Insomnia Severity Index Change Research Articles

Neurological mechanism and efficacy of acupuncture for breast cancer-related insomnia: a study protocol for randomized clinical trial.

Breast cancer survivors (BCSs) are at a higher risk of developing insomnia. The negative effects of cancer-related insomnia (CRI) include depression, anxiety, fatigue, aggressive pain, impaired immune functioning, decreased quality of life, and even increased cancer mortality. Although preliminary progress has been made in the treatment of CRI with acupuncture, the evidence is insufficient and the neurological mechanism underlying the effect of acupuncture is still unclear. The study employs a single-blinded, randomized, controlled trial design. A total of 80 participants will be randomly allocated in a 1:1 ratio to either the treatment group (n = 40) or the control group (n = 40). The former will receive acupuncture treatment, while the latter will receive sham acupuncture treatment. Both groups will receive 12 sessions over a 4-week period, three times per week (every other day), and each session will last for 30 min. Follow-up assessments will be conducted in week 8. The primary outcome will be the treatment response rate. Secondary outcomes include the change in Insomnia Severity Index (ISI), the treatment remission rate, actigraphy sleep assessment, Generalized Anxiety Disorder Scale (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Quality of Life Core Scale (QLQ-C30), the weekly usage of remedial drugs, and functional magnetic resonance imaging (fMRI) analysis. Data for the outcomes will be collected at week 0 (the baseline), week 1 (the intervention period), week 4 (the post-treatment period), and week 8 (the follow-up period). The objective of this study is to assess the efficacy of acupuncture for patients with CRI in comparison with sham acupuncture. Additionally, the research aims to explore the neuropathological mechanisms of CRI and provide the first evidence on the characteristics of acupuncture treatment using fMRI. We expect that the results of this study will provide valuable scientific evidence of acupuncture treatment for CRI.Clinical trial registration: Chinese Clinical Trial Registry, identifier ChiCTR2300070349: https://www.chictr.org.cn/showproj.html?proj=188677.

0394 Effect of electrical vestibular nerve stimulation on sleep quality in young adults with insomnia: a randomized controlled trial

Abstract Introduction Insomnia is a common sleep disorder among all age groups which adversely affects physical and mental health. Young adults are considered a high-risk population group due to increased use of electronic media at bedtime, stress associated with balancing educational demands and unhealthy sleep practices. Previous research suggests that electrical vestibular nerve stimulation (VeNS) may improve sleep outcomes by influencing the hypothalamus and brainstem nuclei involved in regulating the circadian rhythm and wakefulness. The present study is a randomised, double blinded, sham-controlled trial with the aim of assessing the efficacy of VeNS on the sleep quality of young adults suffering from insomnia. Methods Eighty adults aged 18-24 years who scored 15 or higher on the Insomnia Severity Index (ISI) were recruited. Participants assigned to the intervention group (n=40) received 30 minutes per day of VeNS with 5 sessions per week for 4 weeks, while the control group (n=40) received sham stimulation for the same period. ISI scores were recorded at baseline and repeated weekly. The primary outcome was between-group change in ISI from baseline to day 28. Secondary outcomes included between-group change in the emotional states of depression, anxiety and stress measured by the DASS-21 questionnaire, and quality of life (QoL) measured by the WHOQoL-BREF. Results A group-by-time interaction effect on change in ISI score from day 0 to day 28 (F3, 248 = 295.56; P< 0.001) was observed. The intervention group had a higher reduction in mean ISI score relative to the control group at day 28 (mean change [95% CI]: 7.23 [6.78, 7.67] vs. 0.98 [0.89, 1.06], P< 0.001; respectively). Furthermore, the intervention group showed improvements in depression, anxiety, and stress scores (P< 0.001) and QoL outcomes (P< 0.001) compared with the control group. Conclusion Regular VeNS usage over 4 weeks lead to a clinically meaningful decrease in ISI scores and improved general well-being in young adults with insomnia. VeNS may have potential as a drug-free and non-invasive therapy to improve sleep outcomes. Support (if any)

0399 Examining Insomnia Treatment Adherence and Outcomes in Black Women Veterans

Abstract Introduction Black identified women and veterans consistently experience disproportionately higher rates of insomnia. Cognitive behavioral therapy for insomnia (CBT-I) improves sleep outcomes, although higher rates of attrition and sub-optimal adherence in these groups can limit symptom improvement. Few studies have examined CBT-I treatment adherence and outcomes in women veterans, particularly among those who identify as black. . The current study examined differences in adherence and treatment outcomes in Black identified women veterans compared to white identified women veterans who engaged in CBT-I. Methods As part of a larger clinical trial (NCT02076165), 26 black and 25 white women veterans with insomnia disorder completed a 5-session CBT-I program. Insomnia Severity Index (ISI) and sleep diaries were completed at baseline, post-treatment, and 3-month follow-up. Multiple and fractional regression models were used to evaluate the association between race and change in ISI, change in sleep diary sleep efficiency (SE), and adherence to bedtime and rise time during CBT-I. Results Mean change from baseline to 3-month follow-up in ISI score for black and white women were -7.31 and -7.97 and mean change in diary SE was +14.9% and +10.8%, respectively. Race did not impact change-scores for ISI or SE (1.09 < F < 1.8, p>.05); however, in the fractional regression model, (Χ2=6.9, p=.008; pseudo R2=.058) race was a significant predictor (OR=.27, p=.009) of adherence to prescribed bedtime in the second week of CBT-I, with black women less likely to adhere to prescribed bedtime than women. Race was not a significant predictor of wake time adherence. Conclusion Both black and white women veterans benefitted from CBT-I; however, early adherence to the recommended sleep schedule was lower in black women. Future research could expand on these findings by examining potential barriers in early adherence to recommendations, and how to improve early adherence to ensure that therapy meets the needs of all patients. Support (if any) VA/HSR&D IIR-HX002300 (PI: Martin), NIH/NHLBI K24HL143055 and VA HSR&D RCS 20-191. Dr. May supported by the VA Office of Academic Affiliations.

Use of Daridorexant among Patients with Chronic Insomnia: A Retrospective Observational Analysis.

Insomnia is the most prevalent sleep disorder, affecting millions worldwide and taking a heavy toll on patient health with significant social and economic impact. Even though there are multiple different types of insomnia medications and behavioral therapies, there are still many individuals for whom treatment remains ineffective. The objective of this retrospective study was to analyze the effectiveness of daridorexant in a cohort of chronic insomnia patients largely transitioned from GABA-A positive allosteric modulators (benzodiazepines, zolpidem or eszopiclone) or other frequently prescribed insomnia medications (including trazodone, atypical antipsychotics or tricyclic antidepressants). A total of 86 patients were treated in the course of ordinary practice and the primary analytic endpoint was the change in Insomnia Severity Index (ISI) score following ≥ 30 nights of treatment with daridorexant. Results from 80 of the 86 patients with full data (65% female, mean age 53.5 years, 18.8% with comorbid obstructive sleep apnea, 91.3% transitioned from a different medication) showed a mean improvement in ISI score of 7.0 ± 0.54 points (SEM) (p < 0.0001) from 18.0 to 11.0. Overall, 78% of the cohort demonstrated a clinically meaningful improvement as defined by at least a six-point drop in ISI. Total sleep time increased by 54 ± 1.0 min (SEM) (p < 0.0001) from 6.0 h to 6.9 h. Mean sleep latency decreased by 23.9 ± 2.4 min (SEM) (p < 0.0001) from 58.8 min to 34.9 min. Wake after sleep onset decreased by 31.6 ± 3.2 min (SEM) (p < 0.001) from 42.8 min to 11.3 min. Sleep efficiency improved by 10.5 ± 1.1% (SEM) (p < 0.0001) from 79.3% to 89.8%. No significant adverse events were noted during the study duration. Keeping in mind this study's limitations, these data suggest that for insomnia patients with an incomplete response to current therapy, switching to daridorexant is safe and may be an effective alternative treatment.

In-person and telehealth treatment of veterans with insomnia disorder using cognitive behavioral therapy for insomnia during the COVID-19 pandemic.

Cognitive behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for insomnia disorder. The goal of this study was to evaluate clinical benefits of CBT-I to veterans with insomnia disorder during the early months of the COVID-19 pandemic using an uncontrolled observational design. A cohort of 63 Veterans Affairs (VA) mental health providers delivered CBT-I to 180 veterans as part of an evidence-based psychotherapy training program and captured de-identified treatment outcome data through a data portal. The main patient outcomes were change in the Insomnia Severity Index (ISI) total score from the initial clinical assessment session to the last treatment session, response rate (% with ISI change > 7 from assessment to last session), and remission rate (% with ISI < 8 at the last session). We tested the noninferiority of telehealth only compared with at least 1 in-person session. Fifty-six percent of veterans seen for an evaluation completed CBT-I treatment during the structured training program phase and completed an initial and final ISI. Among these veterans, ISI scores decreased by an average of 9.9 points from before to after treatment (P < .001), 66% experienced a clinically meaningful treatment response, and 43% experienced insomnia symptom remission. Benefits were similar whether the veteran received some in-person care or received CBT-I entirely via telehealth. Findings suggest, regardless of treatment modality, CBT-I remained highly effective during the early months of the pandemic, which was a challenging time for both clinical providers and veterans in need of insomnia treatment. Martin JL, DeViva J, McCarthy E, etal. In-person and telehealth treatment of veterans with insomnia disorder using cognitive behavioral therapy for insomnia during the COVID-19 pandemic. J Clin Sleep Med. 2023;19(7):1211-1217.

Cereset Research Standard Operating Procedures for Insomnia: A Randomized, Controlled Clinical Trial.

Interventions for insomnia that also address autonomic dysfunction are needed. We evaluate Cereset Research™ Standard Operating Procedures (CR-SOP) in a pilot randomized, controlled trial. CR-SOP is a less operator-dependent, more generalizable innovation of HIRREM®, a noninvasive, closed-loop, allostatic, acoustic stimulation neurotechnology demonstrated to improve insomnia and autonomic function. Adults with Insomnia Severity Index (ISI) scores of ≥8 were randomized to receive ten sessions of CR-SOP, with tones linked to brainwaves (LB, intervention), or a sham condition of random tones not linked to brainwaves (NL, control). Measures were collected at enrollment and 0-14days and 4-6weeks post-allocated intervention. The primary outcome was differential change in ISI from baseline to 4-6weeks post-intervention. Secondary self-report measures assessed sleep quality65 and behavioral outcomes. Ten-minute recordings of heart rate and blood pressure were collected to analyze autonomic function (heart rate variability [HRV] and baroreflex sensitivity). Of 22 randomized, 20 participants completed the allocated condition. Intention to treat analysis of change from baseline to the 4-6 week outcome demonstrated mean ISI score reduction of 4.69 points among controls (SE 1.40). In the intervention group, there was an additional 2.58 point reduction in ISI score (SE 2.13; total reduction of 7.27, P = .24). Sleep quality and some measures of autonomic function improved significantly among the intervention group compared to control. This pilot study compared use of a standardized, allostatic, acoustic neurotechnology intervention with a sham, active control condition. The magnitude of change in insomnia severity was clinically relevant and similar to the findings in a prior, fully powered trial, but the differential improvement observed was not statistically significant. Significant improvements were demonstrated in sleep quality and some autonomic function measures.

Network meta-analysis comparing the effectiveness of a prescription digital therapeutic for chronic insomnia to medications and face-to-face cognitive behavioral therapy in adults

Objective The purpose of this study was to compare the effectiveness of the only Food and Drug Administration-authorized prescription digital therapeutic (PDT) Somryst versus face-to-face cognitive behavioral therapy for insomnia (CBT-I), or FDA-approved prescription medications for insomnia. Methods A systematic literature review was undertaken to identify relevant studies. A Bayesian network meta-analysis (NMA) was conducted to examine (1) mean change in insomnia severity index (ISI); (2) proportional change in ISI remitters; (3) mean change in wake after sleep onset (WASO); and (4) mean change in sleep onset latency (SOL). Results Twenty studies provided data on the PDT, CBT-I, CBT-I in combination with self-help (SH), or two prescription medications (eszopiclone and zolpidem). The PDT was associated with significant mean change in ISI (–5.77, 95% Credible Interval [CrI] − 8.53, −3.07) and ISI remitters (OR 12.33; 95% CrI 2.28, 155.91) compared to placebo, and had the highest probability of being the most effective treatment overall for ISI mean change (56%), and ISI remitters (64%). All evaluated interventions significantly outperformed placebo for WASO but no significant differences were observed for SOL (five interventions). Sensitivity analyses excluding medications and meta-regression (assessing type, duration, delivery method for CBT-I) did not affect NMA results. Conclusions This network meta-analysis demonstrated that a PDT delivering CBT-I had the highest probability of being most effective compared to face-to-face CBT-I, prescription sleep medications, or placebo, as measured by reductions in mean ISI score from baseline and ISI-determined remittance.

0481 Effectiveness of a digital therapeutic compared to medications and cognitive behavioral therapy for treating chronic insomnia in adults

Abstract Introduction Limitations on the availability of guideline-recommended cognitive behavioral therapy for insomnia (CBT-I) constrain its use and create an unmet need for innovative ways to expand access. Digital therapeutics offer a potential solution. This study compared a digital intervention, traditional face-to-face CBT-I, and prescription medications for insomnia. Methods Of 184 articles identified in a systematic literature review, 13 studies reported ISI mean change from baseline data: 1 using the digital therapeutic (DT) SHUTi (now known as the prescription digital therapeutic Somryst), 1 on the medication eszopiclone, and 11 on traditional CBT. A Bayesian network meta-analysis (NMA) was performed on the mean change from baseline and the proportion of remitters using the insomnia severity index (ISI) endpoint with follow-up timepoints between 6-12 weeks. Mean change in ISI score from baseline was analyzed as a continuous endpoint while comparisons of the proportion of remitters was performed using odds ratios. The analysis used a random-effects model for the base case analysis. A surface under the cumulative ranking curve (SUCRA) analysis was performed to rank the treatments on each endpoint. Results Only the DT and CBT-I were significantly different than placebo. The DT had the greatest mean change from baseline in ISI from placebo (-5.77 points, 95% Credible Interval (CrI) [-8.53, -3.07]), followed by CBT-I (-4.3 points, 95% CrI [-6.32, -2.39]). In the SUCRA analysis, the DT had the highest probability (56%) of being the most effective treatment based on ISI mean change from baseline. 8 studies reported the proportion of ISI remitters. Only the DT showed a statistically significant difference in remission vs. placebo, and the DT had the highest odds ratio for remission vs. placebo (OR 12.33; 95%CrI [2.28, 155.91]). The DT had the highest probability (64%), of being the most effective treatment for inducing remission using ISI definitions. Conclusion The DT in this study was projected to be the most effective therapy on both mean change in ISI and ISI remission within 6-12 weeks of treatment start vs. either traditional CBT-I or medications. Support (If Any) This analysis was funded by Pear Therapeutics, Inc.

0459 The First Step of a Triaged Stepped-Care Delivery of CBTI: A Preliminary Report from the RESTING Study

Abstract Introduction Both online and therapist-led cognitive behavioral therapy for insomnia (CBTI) are effective. However, little is known about the optimal combination and sequence to maximize both access and effectiveness. The RESTING study is a randomized controlled trial assessing the effectiveness of a triaged stepped care approach (STEPPPED-CARE) to delivering CBTI that utilizes a simple five-item Checklist to determine which patients should start treatment with online versus therapist-led CBTI. Methods Adults 50 years and older (N=222; age = 63.1 (SD=8.2); 74% female) with insomnia disorder who met the study’s broad eligibility criteria were randomized to STEPPED-CARE (N=112) or to ONLINE-ONLY CBTI (N=110). Participants in the STEPPED-CARE arm who responded yes to any Checklist item (Checklist Yes) received therapist-led CBTI (N=61); the rest (Checklist NO) received the online CBTI program Sleepio (N=62). All participants in the ONLINE-ONLY arm received Sleepio. Randomization was stratified by Checklist (Yes/No). We used mixed effects models with an Arm by Checklist by Time interaction to determine the effect of STEPPED-CARE on insomnia severity two months after randomization, using the Insomnia Severity Index (ISI). Results A mixed effects model revealed an Arm by Checklist by Time interaction (p=0.013). Post-hoc analyses within stratum revealed that within the Checklist Yes stratum, participants assigned to STEPPED-CARE (all received therapist-led treatment) experienced significantly greater reduction in ISI (from 16.2 (SD=1.2) to 11.6 (SD=2.1)) than those assigned to ONLINE-ONLY (from 16.2 (SD=1.2) to 13.7 (SD=1.4); p=0.007, d=0.22). Among those in the Checklist No stratum, there was no Arm difference in ISI change. The combined mean ISI in the Checklist No group was 14.8 (0.8) at baseline and 11.2 (0.8) at 2 months. Overall, remission of insomnia (ISI&amp;lt;8) was attained by 23% of those in STEPPED-CARE and 15% of those assigned to ONLINE-ONLY. Conclusion Results support the efficacy of the first step of a triaged stepped care approach to CBTI among middle age and older adults with insomnia disorder. Given minimal exclusion criteria, results from the current trial are generalizable to individuals with comorbidities and those who use hypnotics, offering a way to triage patients to digital or therapist-led CBTI effectively and efficiently. Support (If Any) R01AG057500

0466 Living Alone as a Predictor of Symptom Change During Cognitive Behavioral Therapy for Insomnia

Abstract Introduction Interpersonal factors have implications for sleep quality. Research has begun to explore how such factors may play a role in cognitive behavioral therapy for insomnia (CBTI). This study investigated whether living alone predicts reductions in insomnia severity and sleep-related daytime impairment across the first two months of treatment in a trial of CBTI. Methods Participants were 224 middle-to-older-aged adults with insomnia (166 women, M age = 63.16) enrolled in the ongoing Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy (RESTING). All study participants received CBTI, delivered either via a therapist or a validated software program. At baseline, participants indicated whether they lived alone or with at least one other person. The Insomnia Severity Index (ISI) and PROMIS Sleep-Related Impairment (SRI) short form were administered at baseline and two months after starting treatment. Mixed effects models assessed whether living alone predicted reduction in symptoms across the first two months of CBTI. Results Across the total sample, ISI scores decreased from baseline to two months (β=-3.52, SE=0.35, p&amp;lt;.001, 95% CI=-4.20, -2.84). Living alone was not associated with baseline ISI scores nor change in ISI score. A reduction in PROMIS SRI score was also observed in the total sample from baseline to two months (β=-4.18, SE=0.50, p&amp;lt;.001, 95% CI=-5.15, -3.21). Living alone was not associated with baseline SRI score, but it did predict reduction in SRI score (β=-3.23, SE=0.88, p=.001, 95% CI=1.31, 5.15). Participants living alone displayed less reduction in SRI compared to those living with at least one other person. Conclusion Participants undergoing CBTI who live alone experienced reduction in insomnia severity over the course of treatment, but they displayed less improvement in daytime sequalae of poor sleep compared to those living with others. Future studies should further explore how living status contributes to insomnia treatment response across both nighttime and daytime sleep symptomology. Regular engagement with others living in the home may be important for insomnia treatment to translate into perceived functional improvements during the day. Support (If Any) 1R01AG057500

Alteration of gamma-aminobutyric acid in the left dorsolateral prefrontal cortex of individuals with chronic insomnia: a combined transcranial magnetic stimulation-magnetic resonance spectroscopy study

ObjectiveTo investigate changes in the level of gamma-aminobutyric acid (GABA) in the left dorsolateral prefrontal cortex (DLPFC) of patients with chronic insomnia treated with real repetitive transcranial magnetic stimulation (rTMS) as compared to sham-rTMS, as measured with 1H-Magnetic Resonance Spectroscopy (1H-MRS). MethodsForty chronic insomnia participants were randomized to either real or sham rTMS group. The rTMS was administered once per day Continuously for 14 days with the stimulation over the left DLPFC. Left DLPFC GABA level relative to creatine (Cr) was measured by 1H-MRS. Insomnia symptom was evaluated by Insomnia Severity Index (ISI). MRS and ISI were assessed among all participants before and after treatment. This study was registered in the Chinese Clinical Trial Registry (No. ChiCTR2100047255). ResultsAfter treatment, the ISI score in real rTMS group was markedly decreased as compared to pre-rTMS (t = −4.25, p < 0.001, Cohen's d = 0.90), whereas no significant change in ISI was observed in the group of sham rTMS. In addition, we observed a significant increase of GABA+/Cr concentration in the real rTMS group after stimulation (0.37 ± 0.11 to 0.40 ± 0.11, p = 0.039), but that of sham did not (0.38 ± 0.10 to 0.39 ± 0.11, p = 0.151). However, there was no significant association between the change of GABA+/Cr in left DLPFC and the changes of ISI scores in the two groups. Conclusion1 Hz rTMS has the potential to increase GABA + level in left DLPFC of patients with chronic insomnia, and warrants further investigation.

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop

ABSTRACT Study Objectives : Cognitive behavioral treatment for insomnia (CBT-I) is the first line of treatment for insomnia. However, the expanded use of CBT-I is limited by the number of specialty-trained clinicians in addition to the duration and cost of individual treatment sessions. One viable option is a single-session educational group format delivered by a trained health educator. Methods : In a preliminary, single group pretest-posttest design, the effectiveness of group CBT-I delivered to community dwelling individuals with self-reported insomnia symptoms was evaluated. Participants completed the Insomnia Severity Index (ISI) and provided information on sleep aid use, prior to and 1-month post attendance of a single 4-hour CBT-I workshop. Results : Participants (N = 45) were 54 ± 16 years and 71% female. ISI scores significantly improved from baseline (20.09 ± 4.1) to 1-month follow-up (11.89 ±5.7; t = 10.1, p < .001) with an average change of 8.2 ± 5.4 points. Frequency of sleep aid use significantly dropped (χ2 = 105.7, p = .017). Eighty percent of participants reported sleeping better or much better at follow-up. Twenty percent of participants met criteria for remission of insomnia and 35.6% of participants had ISI change scores meeting criteria for a Minimally Important Difference associated with improvements in fatigue, work productivity, and health related quality of life. Conclusions : These preliminary data suggest that a single 4-hour CBT-I workshop delivered by a health educator can significantly improve insomnia symptoms, improve subjective sleep quality, and reduce sleep aid use among community dwelling adults with and without co-morbidities within 1-month.

A double-blind, randomized, placebo-controlled trial of suvorexant for the treatment of vasomotor symptom-associated insomnia disorder in midlife women.

The neuropeptide orexin promotes wakefulness, modulates thermoregulation, increases after menopause, and is normalized in women receiving estrogen therapy, suggesting a role for orexin antagonism as a treatment for the vasomotor symptom (VMS)-associated insomnia disorder. We tested the efficacy of the dual orexin receptor antagonist suvorexant for chronic insomnia related to nighttime VMS. In a double-blind, placebo-controlled trial, 56 women with chronic insomnia associated with nighttime VMS, Insomnia Severity Index (ISI) scores ≥15, and >30 min of diary-rated wake after sleep-onset (WASO) were randomized to receive oral suvorexant 10-20 mg (n = 27) or placebo (n = 29) nightly for 4 weeks. Analysis of within-person change in ISI was adjusted for baseline ISI and race. Mean baseline ISI scores were 18.1 (95% CI, 16.8 to 19.4) and 18.3 (95% CI, 17.2 to 19.5) in the suvorexant and placebo groups, respectively (p = .81). The average 4-week ISI within-person decrease from baseline was greater on suvorexant (-8.1 [95% CI, -10.2 to -6.0]) compared to placebo (-5.6 [95% CI, -7.4 to -3.9], p = .04). Compared to placebo, nighttime diary-rated VMS frequency was significantly reduced with suvorexant (p < .01). While diary-rated WASO and total sleep time trended toward improvement on suvorexant, findings were not significant after adjustment for multiple comparisons. Daytime VMS and other sleep-related outcomes did not differ between groups. Suvorexant was well tolerated. These results suggest that suvorexant is likely a well-tolerated and efficacious treatment for VMS-associated insomnia disorder and reduces nighttime VMS. Antagonism of orexin receptors could provide a novel therapeutic option for midlife women with VMS-associated chronic insomnia. Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia, https://clinicaltrials.gov/ct2/show/NCT03034018, ClinicalTrials.gov Identifier: NCT03034018.

P139 Co-morbid insomnia and sleep apnoea (COMISA): Identifying patients that are responsive to continuous positive airway pressure therapy

Abstract Introduction Co-morbid insomnia and sleep apnoea (COMISA) is a prevalent and debilitating condition that is difficult to treat. COMISA patients have lower average adherence to continuous positive airway pressure (CPAP) therapy compared to patients with sleep apnoea alone. However, a sub-sample of COMISA patients may show adequate CPAP use that improves both the insomnia and sleep apnoea. It is important to identify this group of CPAP-responsive COMISA patients to guide personalised-medicine approaches. Methods Seventy-three COMISA patients (AHI≥15; ICSD-3 insomnia; 55% male, Age M=57y) completed questionnaires, home-based polysomnography, and one-week sleep diaries before and 6-months after commencing CPAP therapy. No patients accessed CBTi. We investigated baseline predictors of CPAP adherence (min/night) and overall change in Insomnia Severity Index (ISI) scores during treatment. Results Average CPAP adherence was 205 minutes/night (SD=153). 56% of patients used CPAP at least 4h/night. Average CPAP adherence was predicted by higher baseline AHI (r=0.39), arousal index (r=0.28), N1 sleep (r=0.32) and age (r=0.26), and lower N3 sleep (r=-0.28). The ISI decreased from baseline (17.9, CI=1.2) to 6-month follow-up (11.6, CI=1.3; p&amp;lt;0.001). There was a significant positive association between ISI reduction and CPAP use (r=0.31). 26% of patients reported an ISI&amp;lt;8 at 6-month follow-up. Conclusion Approximately half of COMISA patients show CPAP adherence of ≥4h/night and one quarter experience insomnia remission with CPAP. CPAP use is positively associated with AHI, light sleep, and age at baseline, and reduction of insomnia severity during treatment. Future randomized controlled trials are required to confirm the results of this small un-controlled study.

Insomnia symptoms and chronic pain: Outcomes of an interdisciplinary pain rehabilitation program.

Insomnia is a highly prevalent problem among patients with chronic pain. Interdisciplinary pain rehabilitation programs (IPRPs) are a leading treatment option for chronic pain; however, research is limited and existing findings are mixed on the impact of insomnia symptoms on IPRP outcomes and the extent to which insomnia symptoms improve as a result of IPRP treatment. In this study, insomnia and pain-related outcomes following a 10-week IPRP were examined from a relatively large sample (N = 393) of adult patients with varying chronic pain conditions who completed the Insomnia Severity Index (ISI) at program admission and discharge. Both group- and individual-level changes in insomnia severity were examined to evaluate statistically and clinically significant changes in insomnia symptoms, along with the impact of insomnia symptoms on measures of pain, emotional distress, and functioning. Participants were categorized as having no clinically significant insomnia symptoms (NCSI), mild, moderate, or severe insomnia based on ISI scores. Higher levels of insomnia severity were associated with worse pain, functioning, and emotional distress. Most patients reporting mild, moderate, or severe insomnia symptoms at program admission moved to a lower insomnia symptom category at the time of discharge (62%); however, only 33% of these patients reported a meaningful score reduction (i.e., ISI change ≥8 points). In addition, insomnia symptoms had a negative impact on treatment gains related to pain interference and physical health-related quality of life. These findings suggest that usual IPRP care confers overall treatment benefit for individuals with chronic pain and insomnia. However, insomnia symptoms may negatively impact pain treatment outcomes and usual care appears insufficient to address elevated insomnia symptoms for many patients. Additional insomnia-specific treatment may be warranted for patients with comorbid chronic pain.

The Effectiveness of Digital Insomnia Treatment with Adjunctive Wearable Technology: A Pilot Randomized Controlled Trial

ABSTRACT Objective This pilot trial aimed to provide evidence for whether the integration of a wearable device with digital behavioral therapy for insomnia (dBTi) improves treatment outcomes and engagement. Participants and Methods One hundred and twenty-eight participants with insomnia symptoms were randomized to a 3-week dBTi program (SleepFix®) with a wearable device enabling sleep data synchronization (dBTi+wearable group; n = 62) or dBTi alone (n = 66). Participants completed the Insomnia Severity Index (ISI) and modified Pittsburgh Sleep Quality Index (PSQI) parameters: wake-after-sleep-onset (WASO), sleep-onset-latency (SOL), and total sleep time (TST) at baseline and weeks 1, 2, 3, and primary endpoint of week 6 and follow-up at 12 weeks. Engagement was measured by the number of daily sleep diaries logged in the app. Results There was no difference in ISI change scores between the groups from pre- to post-treatment (Cohen’s d= 0.7, p= .061). The dBTi+wearable group showed greater improvements in WASO (d= 0.8, p = .005) and TST (d= 0.3, p= .049) compared to the dBTi group. Significantly greater engagement (sleep diary entries) was observed in the dBTi+wearable group (mean = 22.4, SD = 10.0) compared to the dBTi group (mean = 14.1, SD = 14.2) (p = .010). Conclusions This pilot trial found that integration of wearable device with a digital insomnia therapy enhanced user engagement and led to improvements in sleep parameters compared to dBTi alone. These findings suggest that adjunctive wearable technologies may improve digital insomnia therapy effectiveness.

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT.

Study ObjectivesDigital cognitive behavioral therapy for insomnia (dCBT-I) is an effective treatment for insomnia. However, less is known about mediators of its benefits. The aim of the present study was to test if intraindividual variability in sleep (IIV) was reduced with dCBT-I, and whether any identified reduction was a mediator of dCBT-I on insomnia severity and psychological distress.MethodsIn a two-arm randomized controlled trial (RCT), 1720 adults with insomnia (dCBT-I = 867; patient education about sleep = 853) completed the Insomnia Severity Index (ISI), the Hospital Anxiety and Depression Scale (HADS) and sleep diaries, at baseline and 9-week follow-up. Changes in IIV were analyzed using linear mixed modeling followed by mediation analyses of ISI, HADS, and IIV in singular sleep metrics and composite measures (behavioral indices (BI-Z) and sleep disturbance indices (SI-Z)).ResultsdCBT-I was associated with reduced IIV across all singular sleep metrics, with the largest between-group effect sizes observed for sleep onset latency (SOL). Reduced IIV for SOL and wake after sleep onset had the overall greatest singular mediating effect. For composite measures, SI-Z mediated change in ISI (b = −0.74; 95% confidence interval (CI) −1.04 to −0.52; 13.3%) and HADS (b = −0.40; 95% CI −0.73 to −0.18; 29.2%), while BI-Z mediated minor changes.ConclusionReductions in IIV in key sleep metrics mediate significant changes in insomnia severity and especially psychological distress when using dCBT-I. These findings offer important evidence regarding the therapeutic action of dCBT-I and may guide the future development of this intervention.Clinical trials Name: Overcoming Insomnia: Impact on Sleep, Health and Work of Online CBT-I Registration number: NCT02558647 URL: https://clinicaltrials.gov/ct2/show/NCT02558647?cond=NCT02558647&draw=2&rank=1

Polysomnographic Predictors of Treatment Response to Cognitive Behavioral Therapy for Insomnia in Participants With Co-morbid Insomnia and Sleep Apnea: Secondary Analysis of a Randomized Controlled Trial.

ObjectiveCo-morbid insomnia and sleep apnea (COMISA) is a common and debilitating condition that is more difficult to treat compared to insomnia or sleep apnea-alone. Emerging evidence suggests that cognitive behavioral therapy for insomnia (CBTi) is effective in patients with COMISA, however, those with more severe sleep apnea and evidence of greater objective sleep disturbance may be less responsive to CBTi. Polysomnographic sleep study data has been used to predict treatment response to CBTi in patients with insomnia-alone, but not in patients with COMISA. We used randomized controlled trial data to investigate polysomnographic predictors of insomnia improvement following CBTi, versus control in participants with COMISA.MethodsOne hundred and forty five participants with insomnia (ICSD-3) and sleep apnea [apnea-hypopnea index (AHI) ≥ 15] were randomized to CBTi (n = 72) or no-treatment control (n = 73). Mixed models were used to investigate the effect of pre-treatment AHI, sleep duration, and other traditional (AASM sleep macrostructure), and novel [quantitative electroencephalography (qEEG)] polysomnographic predictors of between-group changes in Insomnia Severity Index (ISI) scores from pre-treatment to post-treatment.ResultsCompared to control, CBTi was associated with greater ISI improvement among participants with; higher AHI (interaction p = 0.011), less wake after sleep onset (interaction p = 0.045), and less N3 sleep (interaction p = 0.005). No quantitative electroencephalographic, or other traditional polysomnographic variables predicted between-group ISI change (all p > 0.09).DiscussionAmong participants with COMISA, higher OSA severity predicted a greater treatment-response to CBTi, versus control. People with COMISA should be treated with CBTi, which is effective even in the presence of severe OSA and objective sleep disturbance.

Randomized trial of telehealth delivery of cognitive-behavioral treatment for insomnia vs. in-person treatment in veterans with PTSD

• Insomnia is common in veterans with PTSD. • Cognitive behavioral treatment for insomnia can effectively treat insomnia in this population. • Cognitive behavioral treatment can be delivered via telemedicine without losing clinical effectiveness. Insomnia is prevalent in veterans with PTSD but often goes untreated. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious treatment but many patients do not have access to this intervention. Clinical video telehealth provides a means of increasing access to care but there is a need to understand the effectiveness of care delivered using this modality. Randomized non-inferiority trial comparing group CBT-I delivered between VA clinics over video telehealth to in-person treatment. 116 Veterans with PTSD received CBT-I over six weeks in a group format at a VA healthcare facility. The Insomnia Severity Index (ISI) was the primary outcome measure. Secondary outcomes included measures of sleep, PTSD severity and quality of life. The non-inferiority margin was defined as a difference in ISI change scores between groups ≥1.67 points. The mean(SD) improvement in the ISI was 6.48 (0.90) points for in-person treatment and 4.45 (0.98) points for telehealth treatment in intent-to-treat analyses. In both intent-to-treat and per-protocol analyses, the difference between these change scores of 2.03 had a confidence interval that included the non-inferiority margin of 1.67, supporting the hypothesis of non-inferiority. On secondary outcomes, there were significant improvements after treatment only in sleep quality and no between-group differences. The eligibility criteria were intentionally broad, so there were several potential confounding factors. Drop-out was also considerable, with only 54.3% of subjects in the in-person group and 46.9% in the telehealth group completing treatment. Delivery of group CBT-I by clinical video telehealth to veterans with PTSD is non-inferior to in-person treatment, although overall efficacy of treatment was modest. Telehealth technology can increase access to care without sacrificing clinical gains.

High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) improves symptoms and autonomic function for insomnia: A randomized, placebo-controlled clinical trial.

IntroductionEffective insomnia interventions that also address autonomic dysregulation are lacking. We evaluate high‐resolution, relational, resonance‐based, electroencephalic mirroring (HIRREM®), in a randomized, controlled clinical trial. HIRREM is a noninvasive, closed‐loop, allostatic, acoustic stimulation neurotechnology, to support self‐optimization of brain rhythms.MethodsOne hundred and seven adults (mean age 45.7, SD ± 5.6, 73 women), with Insomnia Severity Index (ISI) scores of ≥15, received ten, 90‐min sessions of HIRREM, with tones linked to brainwaves (LB, 56), or random tones not linked to brainwaves (NL, 51), as an active, sham placebo. Outcomes were obtained at enrollment (V1), 1–7 days (V2), 8–10 weeks (V3), and 16–18 weeks (V4) after intervention. Primary outcome was differential change in ISI from V1 to V3. Secondary measures assessed depression (BDI), anxiety (BAI), quality of life (EQ‐5D), and a sleep diary. Ten minute recordings of HR and BP allowed analysis of heart rate variability (HRV) and baroreflex sensitivity (BRS).ResultsOf 107 randomized, 101 completed the intervention. Intention‐to‐treat analysis (107) of change from V1 to V3 revealed a mean reduction of ISI in NL of −4.93 (SE ± 0.76) points, with additional, significant reduction of −2.05 points (0.74) in LB (total reduction of −6.98, p = .045). Additional reduction of −2.30 points (0.76) was still present in the LB at V4 (p = .058). Total ISI reduction from V1 to V4 was −5.90 points for NL and −7.93 points in LB. There were group differences (p < .05) for multiple HRV and BRS measures (rMSSD, SDNN, HF alpha, and Seq ALL), as well as total sleep time, sleep onset latency, and sleep efficiency. There were no serious adverse events.ConclusionsResults of this controlled clinical trial showed clinically relevant reduction of insomnia symptoms with HIRREM, over, and above an active, sham control, with associated, durable improvement in autonomic cardiovascular regulation.