Mean Insomnia Severity Index Score Research Articles

0426 Shallower sleep depth in the laboratory is not related to insomnia severity

Abstract Introduction In insomnia, classical sleep scoring parameters are often uncorrelated with symptom severity and may not fully capture more subtle alterations in the polysomnogram (PSG) that could contribute to clinical symptoms. The odds ratio product (ORP) is a well-validated, continuous index of sleep depth (range 0=deep sleep; 2.5=full wakefulness) that offers an alternative to traditional staging. It is unknown whether ORP is related to self-reported insomnia severity. We hypothesized that individuals with insomnia would exhibit higher ORP values than healthy controls (reflecting less deep sleep) which would be associated with greater insomnia severity. Methods This is a secondary analysis of data from a study in which n=15 participants with chronic insomnia disorder and n=15 age- and sex-matched healthy controls completed an in-laboratory protocol (N=30; 66% female; 36±8 years; 63% White). Participants had their sleep monitored with in-lab PSG. The Insomnia Severity Index (ISI) was used to estimate sleep disturbance severity. PSG were used to calculate classical sleep scoring parameters as well as the average ORP in each sleep stage. Independent samples t-tests compared means between the insomnia and healthy control groups and Pearson’s correlations assessed relations between PSG/ORP outcome measures and ISI scores. Results The insomnia group’s mean (SD) ISI score was 14.13 (6.00) and significantly higher than the control group’s (1.73 (2.37); corrected p < 0.001). There were no statistically significant between-group differences for classically-scored sleep parameters or average ORP values after correcting for multiple comparisons. Interestingly, means for the insomnia group’s average ORP values tended to be higher than those of the control group’s. ISI scores were not significantly associated with average ORP values across or within groups. Conclusion Insomnia does not appear to be associated with alterations in global sleep depth when measured in a laboratory setting, but there is a need to conduct more detailed analyses on patterns across the night. Support (If Any) Merck, Inc. Investigator Studies Program

0433 Does Social Media Use Before Bed Lead to Sleep Continuity Disturbance?

IntroductionResearch shows that the use of electronics before bed can negatively impact the circadian rhythm and sleep. Less is known, however, about social media use in relation to sleep continuity disturbance (i.e., insomnia). In the early months of the COVID-19 pandemic, social media use increased and updates about the pandemic were easily accessible online. It is possible that social media use before bed could introduce additional psychological stressors due to availability of negative content online and known correlations to depression and anxiety. Thus, the aim of this research was to examine how social media use before bed influenced different subtypes of insomnia during the initial months of the pandemic.Methods4,138 adults (mean age = 45.8 years; 79% women) completed a national online survey during April – June 2020. Social media use before bed was measured using the first item on the Social Media Engagement questionnaire (i.e., “How often do you use social media in the 15 minutes before you go to sleep?”). Participants responded to this item based on how many days per week (range = 1-7). Sleep disturbance was assessed using a retrospective sleep diary and the Insomnia Severity Index (ISI). The sleep diary asked about sleep continuity (e.g., sleep latency, wake after sleep onset, total sleep time) during the past month.ResultsResults from separate regression analyses supported that social media use before bed was positively related to greater ISI scores, b = 0.25, t = 8.0, p < 0.001. For example, those who use social media before bed every day reported greater mean ISI scores and sleep latency times (mean ISI = 9.5; SL = 37.5 minutes) compared to those who reported never using social media before bed (mean ISI = 7.7; SL = 27.9 minutes). In contrast, social media use before bed was not related to other sleep continuity variables.ConclusionThe present data supports that social media use before bed is related to insomnia symptoms, specifically difficulty with sleep initiation. These findings are significant as they may help us understand which aspects of insomnia are most vulnerable to the negative impact of online social interactions, especially during a highly stressful period, such as the COVID-19 pandemic.Support (If Any)K23HL141581 (PI: Vargas); R25HL10544 (PI: Jean-Louis); K24AG055602 (PI: Perlis)

Real-world evidence from users of a behavioral digital therapeutic for chronic insomnia

BackgroundThere have been many research trials of various digital therapeutics, but few real world evaluations of their efficacy. This type of data, however, can provide a more rounded understanding of their impact, utility, reach, and adoption. Findings presented here focus on outcome and patient engagement data of SHUTi (Sleep Health Using the Internet), a digital therapeutic delivering Cognitive Behavioral Therapy for insomnia (CBT-I), in a large real-world dataset of adults with insomnia. Methods7216 adults who purchased access to SHUTi between December 2015 and February 2019 are included in the analysis. The Insomnia Severity Index (ISI) was administered at the beginning of each of six treatment Cores of the intervention. Users entered sleep diaries between Cores to track changes in sleep over time and obtain tailored sleep recommendations. Number of Cores completed and sleep diaries entered indicate program usage. ResultsUsers showed a reduction in mean ISI scores and a corresponding increase in effect size at the start of each subsequent Core (compared to Core 1) (range: d = 0.3–1.9). Effect sizes at the last Core relative to the first were moderate-to-large for diary-derived sleep onset latency and wake after sleep onset. A reduction in number of medicated nights was also found, with those with severe insomnia showing the largest reduction from last-to-first week of treatment (d = 0.3). At the last Core, 61% met criteria for meaningful treatment response (reduction of >7 points on ISI) and 40% met criteria for remission (ISI<8). Engagement was comparable to SHUTi research trials. ConclusionConsistent with controlled trials, real-world data suggest that digital therapeutics can result in relatively high levels of engagement and clinically meaningful sleep improvements.

Evaluating the Sleep Treatment Education Program (STEP-1): A single-session educational workshop addressing insomnia in cancer survivors

Insomnia is a common late effect of cancer, affecting as many as 27% of cancer survivors. Although cognitive behavioral therapy for insomnia (CBT-I) is highly effective, treatment-associated burdens and limited availability of providers result in few survivors receiving this treatment. To address this gap, we developed the Sleep Treatment Education Program-1 (STEP-1), a single-session intervention addressing insomnia after cancer. As a preliminary evaluation of STEP-1’s potential to improve survivors’ insomnia, STEP-1 was delivered to a convenience sample of 34 cancer survivors as an educational workshop in person or by videoconference. Participants completed the Insomnia Severity Index (ISI) at the workshop and at 1-month follow-up; items assessing participants’ intentions to implement program suggestions and satisfaction were also collected. At 1-month follow-up, mean insomnia symptoms on the ISI were significantly lower compared to baseline (9.73 vs 15.73; d = 1.38, P < .001); the reduction in mean ISI scores did not significantly differ between in-person and videoconference participants (5.82 vs 6.33; P = .78). These results, along with positive indicators of program engagement and satisfaction, support the potential efficacy of STEP-1 to meet survivors’ needs for insomnia care. Particularly when delivered by videoconference, STEP-1 has the potential to dramatically improve access and uptake for insomnia treatment in cancer survivors. Results also more generally support development of low-intensity, self-management insomnia interventions for cancer survivors and potentially other populations.

Electroacupuncture for treating cancer-related insomnia: a multicenter, assessor-blinded, randomized controlled, pilot clinical trial

BackgroundInsomnia is one of the most frequent symptoms in people with cancer. Electroacupuncture has been widely used in people with cancer or insomnia. We explored the feasibility and preliminary effectiveness of electroacupuncture for cancer-related insomnia.MethodsPeople with cancer and insomnia disorder were randomly allocated to electroacupuncture, sham-electroacupuncture, or usual care groups. Participants received either 10 sessions of electroacupuncture at real acupoints, sham-electroacupuncture at non-acupoints, or usual care in each group for 4 weeks. We calculated the recruitment, adherence, and completion rates of participants. The Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diary and actigraphy-derived sleep parameters, Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Montreal Cognitive Assessment (MoCA), and salivary levels of cortisol and melatonin were evaluated as outcome measures.ResultsTwenty-two participants were enrolled (8, 6, and 8 respectively in the electroacupuncture, sham-electroacupuncture, and usual care groups) and 20 participants completed the trials (8, 4, and 8 respectively). The recruitment, adherence, and completion rates were 78.57% (22/28), 95.45% (21/22), and 90.91% (20/22), respectively. Most of the participants had previously received conventional treatment for insomnia, but few had received Korean medicine treatment, without any demographic or clinical differences between groups. In the electroacupuncture group, there was a statistically significant reduction of 10.13 (mean) ± 8.15 (standard deviation) and 5 ± 3.70 points in mean ISI and PSQI scores at 4 weeks post-treatment (P = .0098 and .0066), compared with sham-electroacupuncture (2.06 ± 7.15 and 1.61 ± 4.34; P = .4796 and .3632) and usual care (3.25 ± 2.60 and 1.38 ± 2.13; P = .0096 and .1112). Although there was no significant difference in ISI score between groups at 4 weeks post-treatment, the electroacupuncture group continued to improve significantly at 4 weeks’ follow-up, showing borderline and significant differences compared to the sham-electroacupuncture and usual care (P = .0614 and .0015). The FACT-F scores in electroacupuncture group showed a significant improvement compared with the sham-electroacupuncture group (P = .0305). No electroacupuncture-related adverse events were reported.ConclusionsElectroacupuncture might be feasible for cancer-related insomnia, despite slow participant recruitment. Additional trials with adequately powered sample sizes and a substantial change to the recruitment procedure are needed.Trial registrationClinical Research Information Service, KCT0002162. Submitted 27 October 2016, Registered 2 December 2016 - Retrospectively registered (The first participant enrolment: 28 November 2016),

Prevalence of Sleep Disturbances During COVID-19 Pandemic in a Nepalese Population: A Cross-Sectional Study

Objectives: The coronavirus disease (COVID-19) pandemic and news of daily increasing cases inside Nepal and worldwide is adding to the fear that leads to anger, anxiety, frustration, and stress, emotions that directly affect sleep quality. This study aimed to assess sleep disturbances during the COVID-19 pandemic in a Nepalese population.Methods: This cross-sectional study recruited 206 Nepali residents who completed anonymous self-administered questionnaires. The Insomnia Severity Index (ISI) questionnaire was used to measure sleep disturbances before and after the COVID-19 pandemic. The gathered data were analyzed using descriptive statistics and inferential statistics using SPSS version 20 statistical software.Results: There was a significant variation in sleep disturbances among Nepalese residents before versus after the COVID-19 pandemic (p&lt;0.001). The prevalence of clinical moderate insomnia has increased tremendously in Nepalese individuals. Before the pandemic’s onset, only 3.9% of the participants had moderate to severe levels of clinical insomnia; after its onset, this value increased to 17.5%. The mean ISI scores were 6.35±4.65 and 8.01±6.01 before and after the pandemic’s onset, respectively.Conclusions: Our study findings suggest that people are suffering tremendously with sleep disturbances and calls for further research and active measures to help increase sleep quality during the COVID-19 pandemic.

Effects of melatonin on sleep disturbances in multiple sclerosis: A randomized, controlled pilot study.

BackgroundSleep disturbances are commonly reported by people with multiple sclerosis (PwMS). However, optimal management of sleep disturbances is uncertain, and objective studies of sleep quality in PwMS are scarce.ObjectivesTo determine the effect of exogenous melatonin on sleep quality and sleep disturbances in PwMS.MethodsThirty adult PwMS reporting sleep difficulties were recruited in a randomized, controlled, double-blind cross-over study. They took either melatonin or placebo for 2 weeks, and the opposite for the following 2 weeks. During weeks 2 and 4, an actigraph was used to capture mean total sleep time and sleep efficiency. Patient-reported outcomes (PROs) were collected at weeks 0, 2 and 4.ResultsMelatonin use significantly improved mean total sleep time (p = 0.03), with a trend towards higher sleep efficiency (p = 0.06). No PROs were significantly different; there was a trend for melatonin use to decrease mean Insomnia Severity Index score (p = 0.07), improve Pittsburgh Sleep Quality Index sleep quality component (p = 0.07), and improve NeuroQoL-Fatigue (p = 0.06). No other PROs showed differences between melatonin and placebo; nor did step count measured by actigraphy (all p > 0.45).ConclusionThese results provide preliminary evidence that melatonin, a low-cost, over-the-counter supplement, could improve objective measures of sleep quality in PwMS.

Effectiveness of Internet-Based Cognitive-Behavioral Therapy for Insomnia during Quarantine of Severe Acute Respiratory Syndrome Coronavirus 2 Pandemic: A Controlled Trial

Background and Objective: In the late 2019, an acute respiratory syndrome [severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)] resulted in a pandemic coronavirus disease (COVID-19). This study was designed to compare the efficacy of internet-based cognitive behavioral therapy for insomnia (ICBT-I) with online relaxation training for management of insomnia during SARS-CoV-2 pandemic. Materials and Methods: This controlled trial was conducted on adults (18-65 years) with the complaint of insomnia who called psychology call centers in Mashhad, Iran, from March to June 2020. Participants with insomnia symptoms starting after SARS-CoV-2 pandemic who had Insomnia Severity Index (ISI) scores of ≥ 15 were included in the study. Five weekly sessions of ICBT-I as the intervention were compared with 5 weekly online relaxation training sessions in the control group. ISI before and after 5 weeks of follow-up was compared in both groups. Results: From a total cohort of 144 subjects included in the study, 98 were excluded and the remainder were allocated to 23 cases and 23 control subjects. During follow-up period, 5 individuals (21.7%) dropped out in each group. The mean ISI scores improved after therapy (20.6 to 8.5 and 21.8 to 13.0 for intervention and control groups, respectively). Conclusion: ICBT-I significantly improved insomnia severity during home quarantine of SARS-CoV-2 pandemic. We suggest that ICBT-I could be an effective and feasible alternative in pandemic of an infectious disease. Clients accepted ICBT-I with a minor drop-out in our study.

A Prospective Study Evaluating Sleep Quality and Disorders in Post-ARDS Patients.

IntroductionCritically ill patients are predisposed to developing sleep disorders due to multiple factors like pre-existing sleep disorders, severe acute illness, sleep-altering medical interventions, and the disturbing intensive care unit (ICU) environment. In the current study, a multi-modality approach has been attempted to capture the different aspects of sleep disturbances, including insomnia (using ISI), daytime sleepiness (using ESS), sleep quality (using PSQI), sleep architecture, and SDB (using PSG).Materials and MethodsThe eligible ARDS survivor patients were updated about the study's design prior to hospital discharge. At admission, data regarding demographic details, clinical history, etiology of ARDS, and PaO2/FiO2 (P/F) ratio at presentation, Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) scores was collected. All enrolled patients were evaluated twice (early-within 7 days of admission and late-after 6 weeks of discharge) by the Richards–Campbell Sleep Questionnaire (RCSQ), Insomnia severity index (ISI), and level 1 PSG. Additionally, ESS questionnaire and the Pittsburgh Sleep Quality Index (PSQI) were also recorded in late evaluation. Abnormal sleep was defined if one or more of the following characteristics met: ISI > 15, ESS > 10, global PSQI > 5, AHI ≥ 5 events/h.ResultsThirty patients were recruited out of the total of 88 ARDS patients screened at admission. The median (IQR) PaO2/FiO2 ratio and APACHE II scores were 176 (151–191.5) and 14 (14–16), respectively. The median (IQR) duration of stay in the ICU was 10 (7.3–19.5) days. The median RCSQ score in the early and late evaluation was 42 and 69, respectively. The mean ISI score in the early evaluation was 16.67 ± 4.72, which decreased to 11.70 ± 5.03 in late evaluation (p < 0.05). ISI score > 15 (clinical insomnia) was found in 18 out of 30 subjects (60%) in early evaluation and 11 out of 30 (36%) in late evaluation. During the early evaluation, sleep efficiency was low (median 59.9% and predominantly N1 and N2) which improved in late evaluation (median 80.6%). Of the 30 patients, only 4 had AHI > 5 in early evaluation and none in late evaluation. Neither of P/F ratio, SOFA, and APACHE II scores did correlate with ICU events in the early and late evaluations. Regression analysis showed subjects with ICU stay more than 10 days, duration of IMV more than 7 days, Fentanyl more than 7 mg, duration of sedative use more than 7 days was independently associated with poor objective sleep quality (low sleep efficiency, low TST and high arousal index) during the early and late evaluations after ICU discharge compared to counterparts (p value < 0.05).ConclusionWe conclude that sleep quality in ARDS survivors was poor within 7 days of ICU discharge, characterized by severe disruption of sleep architecture and sleep-disordered breathing. After 6 weeks of ICU discharge sleep quality showed significant improvement in the N3 stage and AHI, however persistent insomnia was observed even at 6 weeks. Therefore, prior identification of risk factors and early diagnosis of sleep quality disorders in post-ARDS patients is essential.

A population-based psychometric analysis of the insomnia severity index in black women with and without a history of cancer.

Black women are under-represented in insomnia research. Further, cancer treatments increase the risk of late effects, thus affecting the sleep of psychologically and medically vulnerable cancer survivors. The Insomnia Severity Index (ISI) is widely used, but has not been researched in black women, and research in cancer survivors is limited. Prior studies demonstrate that psychometric properties of the ISI are not consistent across samples. This study examined the internal consistency and factor structure of the ISI in 29,500 participants from the Black Women's Health Study, an epidemiological study of black women in the United States. This cohort included 28,214 women without a cancer history and 1,286 cancer survivors. Exploratory, confirmatory and multigroup analyses were conducted to determine the psychometric properties of the ISI in these groups. The mean ISI score was 7.18 (standard deviation [SD]=6.82). Findings supported the internal consistency reliability of the ISI in black women with (Ω=0.896) and without (Ω=0.892) a cancer history. Exploratory factor analyses supported a one-factor structure. Confirmatory factor analyses indicated that fit of this one-factor model was not robust in survivors (Satorra-Bentler chi-square [χSB2 (14)]=197.78, comparative fit index [CFI]=0.928, root mean-square error of approximation [RMSEA]=0.143) or in women with no cancer history (χSB2 (14)=2,887.93, CFI=0.945, RMSEA=0.121), but the alternative models we examined were not superior. Although factor structures in previous studies have varied considerably, we found a one-factor structure. Although internal consistency reliability was strong, factor analytic results did not further support the ISI. Inconsistencies in ISI measurement properties across studies may reflect differences in sample sizes and populations.

Effectiveness of App-Based Yoga of Immortals (YOI) Intervention for Insomnia in Asian Population during Pandemic Restrictions.

The coronavirus disease 2019 (COVID-19) pandemic created significant psychological challenges worldwide, including stress, emotional distress, and insomnia. In addition, social distancing, travel restrictions, and spread of disease have resulted in unique challenges, creating barriers to healthcare access. Compared to the rate prior to the COVID-19 pandemic, a significant increase in clinical insomnia rates have been reported. With well-known limitations of currently established treatments (e.g., cognitive behavioral therapy-insomnia (CBT-I), pharmacotherapy), there is a need to explore other effective and safe treatment modalities to treat insomnia, especially those that can be used remotely. The purpose of this study is to assess the effectiveness of app-based intervention to treat insomnia in the current era of the COVID-19 pandemic (using the Yoga of Immortals (YOI) app). This prospective cohort study was approved by the Institutional Review Board. All participants in this study were asked to complete an online survey including demographic data and validated Insomnia Severity Index (ISI) at baseline (15 May 2020), 4 weeks, and 8 weeks after starting the YOI intervention. Survey data was exported using Microsoft Excel. Statistical analysis was done using the GraphPad Prism 8. YOI intervention significantly improved the mean ISI scores in all categories of insomnia (severe, moderate, and subthreshold) at each follow-up (p ≤ 0.0001). The improvement was significant among all age groups and in both genders. In our study, YOI was a novel and effective intervention for improving insomnia symptoms and may be a new addition to the armamentarium of insomnia management. Being app-based, this has potential wider applicability, especially during the current COVID-19 pandemic.

Prevalence of Insomnia among Pancreatic Cancer Patients following Pancreaticoduodenectomy.

Introduction Sleep disturbances are more common in cancer patients than in the general population; however, there is limited research pertaining to the occurrence of such disturbances that subsequently impact patients' quality of life. The aim of our study is to describe the prevalence of insomnia among pancreatic cancer patients who have recently undergone recent pancreaticoduodenectomy. Methods We performed a 6-year (2014-2020) retrospective cohort analysis of all adult patients aged 18 and above with pancreatic cancer who underwent pancreaticoduodenectomy at our institution. Insomnia was characterized using the Pittsburgh Sleep Quality Index (PSQI). Symptoms of insomnia and the impact caused by these symptoms on daily lives were assessed with the Insomnia Severity Index (ISI), and patients were divided into mild insomnia (ISI 8–14) or moderate to severe insomnia (ISI ≥ 15). Results Out of forty patients with pancreatic cancer that have undergone pancreaticoduodenectomy, 19 (47.2%) reported that their sleep disturbances had a significant effect on their quality of life. A total of 22 (55.0%) patients reported insomnia, with 63.2% reporting mild insomnia. Chemotherapy was found to significantly increase the risk of moderate to severe insomnia. The mean ISI score was 7.2 ± 6.9, and the mean PSQI score was 7.0 ± 5.1. ISI and PSQI showed a strong positive correlation (r = 0.78, p < 0.01). Conclusion Sleep disturbances such as insomnia following pancreatic cancer surgery are highly prevalent. Treating physicians and surgeons should recognize and routinely screen for sleep disorders through the management of a multidisciplinary team in order to alleviate some of the burden on the patients' mental well-being.

345 Preliminary efficacy of CBT-I for psychosis in a Veteran sample

Abstract Introduction Sleep dysfunction is pervasive in people with psychosis. Insomnia worsens psychotic symptoms and functioning, though treating insomnia can improve functioning. Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective treatment, but there has been limited research on CBT-I in persons with psychosis. There is mounting evidence that sleep disturbances in people with psychiatric disorders do not improve with treatment of psychiatric illness. The present study 1) developed empirical guidelines for tailoring CBT-I to the needs of people with psychosis and insomnia; 2) conducted a preliminary efficacy study of CBT-I with these novel guidelines for psychosis; and 3) utilized objective and subjective insomnia and functional measures. Methods Novel psychosis guidelines were developed in response to illness-related, environmental, and practical challenges for engaging in traditional components of CBT-I, identified via a series of 25 qualitative interviews and an uncontrolled acceptability trial. A preliminary efficacy study of CBT-I with novel psychosis guidelines was conducted against an active treatment comparison group. Forty-seven Veterans with insomnia and co-occurring psychotic-spectrum disorder completed sleep measures, including the Insomnia Severity Index (ISI), at baseline, post-treatment, and 3-month follow-up. Results Psychosis guidelines for CBT-I included supporting integrated care (e.g., with case managers, prescribers, etc.), simplifying instructions on all treatment materials, reminder handouts, reality testing with sleep-related experiences, cognitive restructuring guidance for common sleep-related cognitions held by people with psychosis, techniques for use during psychotic experiences at bedtime. At post-treatment and follow-up, there was a large effect of CBT-I on ISI scores (d = 1.00, 1.18, respectively). Further, a clinically significant reduction in mean ISI score of participants was observed in the CBT-I condition (&amp;gt; 6), but not in the control condition. Participants in the CBT-I group reported reductions in daily functional impairment due to sleep problems (from 89% to 50%), while the control group reported a slight increase in functional impairment (from 86% to 88%). Conclusion CBT-I delivered with guidelines for psychosis should be further investigated with a larger randomized controlled trial over a longer time period of 6 months. Support (if any) Time on this project was supported by the U.S. Department of Veterans Affairs, Rehabilitation Research and Development Service-1IK2RX001836, PI: Elizabeth A. Klingaman.

Incidence of and Factors Associated with New-Onset Insomnia Among Lebanese Hospitalised Patients: A single-centre study.

ObjectivesThis study aimed to determine the incidence and post-discharge resolution of new-onset insomnia in hospitalised patients with no previous history of insomnia, as well as to define major correlates of in-hospital insomnia.MethodsThis prospective observational study was conducted between November 2019 and January 2020 at a tertiary care centre in Lebanon. All hospitalised patients >18 years of age with no history of insomnia were screened for new-onset insomnia using the Insomnia Severity Index (ISI) scale. Subsequently, patients were re-assessed two weeks after discharge to determine insomnia resolution.ResultsA total of 75 patients were included in the study. Of these, nine (12%) had no insomnia, 34 (45.3%) had subthreshold insomnia, 22 (29.3%) had moderate insomnia and 10 (13.3%) had severe insomnia. The mean ISI score was 14.95 ± 6.05, with 88% of patients having ISI scores of >7 (95% confidence interval: 0.822–0.965). The frequency of new-onset insomnia was significantly higher among patients who shared a room compared to those in single-bed rooms (95.7% versus 75%; P = 0.011). Other factors were not found to be associated with new-onset insomnia, including the administration of medications known to cause insomnia, in-hospital sedative use, overnight oxygen, cardiac monitoring and self-reported nocturnal toilet use. Overall, insomnia resolution occurred in 78.7% of patients two weeks after discharge.ConclusionThere was a high incidence of acute new-onset insomnia among hospitalised patients at a tertiary centre in Lebanon. Additional research is recommended to further examine inhospital sleep disturbance factors and to seek convenient solutions to limit insomnia.

Efficacy of simplified-cognitive behavioral therapy for insomnia(S-CBTI)among female COVID-19 patients with insomnia symptom in Wuhan mobile cabin hospital.

BackgroundThe outbreak of Coronavirus Disease-2019 (COVID-19) caused great psychological distress often with comorbid insomnia. Insomnia is common in patients with COVID-19 admitted to mobile cabin hospitals. Insomnia may lead to immune dysfunction, a condition not conducive to recovery from COVID-19. The use of sedative-hypnotic drugs is limited by their inhibitory effect on the respiratory system. A paucity of research is available regarding psychotherapy interventions to improve insomnia symptoms among patients with COVID-19. In the general population, sleep problems are more common in women than in men; insomnia in women patients requires special attention.The aim of this study was to develop simplified-cognitive behavioral therapy for insomnia (S-CBTI) for patients with COVID-19 and comorbid insomnia symptoms and to verify its effectiveness through a self-control trial. A second aim was to compare the effectiveness of S-CBTI between acute and chronic insomnia among women with COVID-19 and comorbid insomnia symptoms in Wuhan Jianghan Cabin Hospital.MethodsS-CBTI consisted of education on COVID-19 and sleep hygiene, stimulus control, sleep restriction, and self-suggestion relaxation training over a period of two consecutive weeks. Of 67 women, 66 completed psychological intervention and baseline and post-intervention assessments. There were 31 women with acute insomnia and 35 with chronic insomnia. The Insomnia Severity Index (ISI) score and self-compiled sleep data were assessed at baseline and post-intervention, and subjective sleep evaluations were assessed at days 4, 7, 12, and 14.ResultsThe ISI score, sleep latency, night sleep time, and sleep efficiency were statistically significantlly improved from baseline to post-intervention by paired T-test. After the intervention, the mean ISI score of the acute insomnia group was lower than that of the chronic insomnia group. The reduction of the ISI score and the improvement of sleep time from baseline to post-intervention in the acute insomnia group were greater than those in the chronic insomnia group. Utilization of sedative-hypnotic drugs in the acute insomnia group was less than that in the chronic insomnia group, and the difference was statistically significant.ConclusionsS-CBTI can improve the insomnia symptoms of women with COVID-19 in mobile cabin hospitals, especially for stress-related acute insomnia.

The effect of nurse-led Internet-based cognitive behavioural therapy for insomnia on patients with cardiovascular disease: A randomized controlled trial with 6-month follow-up.

AimTo test the effect of nurse‐led Internet‐based cognitive behavioural therapy for insomnia (I‐CBTI), tailored for patients with cardiovascular disease (CVD), with a 6‐month follow‐up.DesignA two‐arm parallel‐group randomized controlled trial (RCT) registered at clinicaltrials.gov (NTC03938805) and reported according to the CONSORT checklist.MethodsForty‐eight patients (mean age 72 years, 65% men) diagnosed with CVD and insomnia were randomized to either 9‐week nurse‐led I‐CBTI with support, or an Internet‐based self‐study programme without support (control group). Insomnia Severity Index (ISI) and Short Form Health Survey (SF‐12) were used as primary and secondary outcomes.ResultsISI showed a significant treatment effect of I‐CBTI compared to the control group at 9‐week follow‐up. The mean ISI score in the I‐CBTI group at 9 weeks post‐treatment was maintained at the 6‐month follow‐up. Patients' adherence to I‐CBTI was associated with a better effect on both the ISI and SF‐12.

Smartphone-Based Virtual Agents to Help Individuals With Sleep Concerns During COVID-19 Confinement: Feasibility Study.

BackgroundThe COVID-19 crisis and consequent confinement restrictions have caused significant psychosocial stress and reports of sleep complaints, which require early management, have increased during recent months. To help individuals concerned about their sleep, we developed a smartphone-based app called KANOPEE that allows users to interact with a virtual agent dedicated to autonomous screening and delivering digital behavioral interventions.ObjectiveOur objective was to assess the feasibility of this app, in terms of inclusion rate, follow-up rate, perceived trust and acceptance of the virtual agent, and effects of the intervention program, in the context of COVID-19 confinement in France.MethodsThe virtual agent is an artificial intelligence program using decision tree architecture and interacting through natural body motion and natural voice. A total of 2069 users aged 18 years and above downloaded the free app during the study period (April 22 to May 5, 2020). These users first completed a screening interview based on the Insomnia Severity Index (ISI) conducted by the virtual agent. If the users were positive for insomnia complaints (ISI score >14), they were eligible to join the 2-stage intervention program: (1) complete an electronic sleep diary for 1 week and (2) follow personalized sleep recommendations for 10 days. We collected and analyzed the following measures: sociodemographic information, ISI scores and sleep/wake schedules, and acceptance and trust of the agent.ResultsApproximately 76% (1574/2069) of the app users completed the screening interview with the virtual agent. The virtual agent was well accepted by 27.4% (431/1574) of the users who answered the acceptance and trust questionnaires on its usability, satisfaction, benevolence, and credibility. Of the 773 screened users who reported sleep complaints (ISI score >14), 166 (21.5%) followed Step 1 of the intervention, and only 47 of those (28.3%) followed Step 2. Users who completed Step 1 found that their insomnia complaints (baseline mean ISI score 18.56, mean ISI score after Step 1 15.99; P<.001) and nocturnal sleep quality improved significantly after 1 week. Users who completed Step 2 also showed an improvement compared to the initial measures (baseline mean ISI score 18.87, mean ISI score after Step 2 14.68; P<.001). Users that were most severely affected (ISI score >21) did not respond to either intervention.ConclusionsThese preliminary results suggest that the KANOPEE app is a promising solution to screen populations for sleep complaints and that it provides acceptable and practical behavioral advice for individuals reporting moderately severe insomnia.

The Frequency of Pregnancy Associated Sleep Disorders Among Pregnant Mothers Who Referred to Rasoul-Akram Hospital for Prenatal Care 2018 - 2019

Background: Sleep, a physiological need, may be disturbed during pregnancy due to the psychological, anatomical, biochemical, hormonal, and emotional adaptations. Objectives: The present study aimed to investigate the frequency of morningness/eveningness, insomnia, and sleep disorders in pregnant mothers. Methods: All healthy pregnant women who referred to Rasoul-Akram Hospital in 2018-2019 for prenatal care without severe medical diseases were included in the study by census method. They were asked to fill their demographics, Morningness Eveningness questionnaire (MEQ), Pittsburgh sleep quality index (PSQI), and insomnia severity index (ISI) after signing their informed consent. The data were analyzed using SPSS V.21. Women who gave birth before the third trimester were excluded from analysis. Results: A total of 347 women completed the study; mean age: 31.46 ± 5.36 years, mean gestational age: 24.68 ± 9.62 weeks. The mean MEQ score was 48.77 ± 5.15; 8.1% were moderate evening type, 85.3% intermediate, and 2.6% moderate morning type. Mean ISI score was 16.92 ± 5.51; 91.9% had insomnia; 31.1% reported (rather or very) poor sleep quality. The frequency of insomnia (based on ISI scores) and sleep disorders (based on PSQI dimensions) were neither different among the three trimesters of pregnancy, nor between complicated and uncomplicated pregnancies (P &gt; 0.05). The MEQ score (P = 0.008, OR = 4.275) was positively, and the academic degree was negatively (P = 0.005, OR = 0.202) associated with sleep disorder. Conclusions: The majority of pregnant mothers reported insomnia, and about one-third reported poor sleep quality, indicating the necessity of paying greater attention to the sleep disorders of pregnant women from the early trimester to prevent further complications.

CORONAVİRÜS HASTALIĞI 2019 (COVİD 19) DÖNEMİNDE ÜNİVERSİTE ÖĞRENCİLERİNDE UYKU KALİTESİ VE İNSOMNİ ŞİDDETİ

Objective: To determine the sleep quality and insomnia severity of university students and the factors affecting them during the coronavirus pandemic (COVID-19) process. Materials and Methods: Our study was conducted by e-mail using Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and Perceived Stress Scale (PSS) between 15 March and 31 May 2020 at our university's Health Services Vocational School. Results: 446 (414 F, 32 M) students participated in the study. Participants' mean time to fall asleep is 26.19 ± 22 minutes, and their average sleep time is 7.98 ± 2.10 hours. PSQI total score average is 15.69 ± 2.96. The mean PSS score was determined as 30.94 ± 8.46. The mean ISI score is 10.87 ± 5.35 and its level is above the lower threshold. It is observed that the group with the curfew has a lower severity of insomnia than the group without it. Sleep quality and perceived stress differ according to alcohol use, but insomnia severity does not differ. It has been found that those who consume more than 2 cups of coffee a day have the worst sleep quality and the highest severity of insomnia. It was found that the participants who did not exercise at all and those who spent 3 hours or more a day on social media had the highest perceived stress level. Conclusion: It is seen that measures applied as staying at home during the COVID-19 pandemic have a negative effect on sleep health.

Evaluation of sedative effects of an intranasal dosage form containing saffron, lettuce seeds and sweet violet in primary chronic insomnia: A randomized, double-dummy, double-blind placebo controlled clinical trial

Ethnopharmacological relevanceTraditional Persian Medicine (TPM) has been established as a valuable source of medicinal plants for the treatment of insomnia for thousands of years. Accordingly, oil extracts from plants’ parts have been widely used to alleviate central nervous system (CNS) ailments including sleep disorders. A number of preparations have been recommended by TPM for the treatment of insomnia. Among them, an intranasal formulation containing oily macerates of Viola odorata L., Crocus sativus L. and Lactuca sativa L. stands out. Aim of the studyIn the present double-dummy, double-blind placebo controlled clinical trial, we aim to evaluate the effectiveness of a combination of violet oil, saffron oil, and lettuce seeds oil nasal drop compared with the placebo (sesame oil). Materials and methodsFifty patients with primary chronic insomnia were randomly assigned in TPM-treatment or placebo groups, received either two drops of the herbal oil or placebo into each nostril every noon and evening for 8 weeks. Before the study commencement and after 1, 4 and 8 weeks of treatment, Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires were completed by all patients. The primary outcome measure was considered as any changes in ISI scores between the first visit and after 8 weeks. Changes in PSQI scores during the study and possible side effects were also assessed. The multicompound herbal oil was standardized using HPLC analysis and contained 0.02 mg/mL crocin and 4 μg/mL isoquercitrin. ResultsOur study revealed a significant reduction in the ISI and PSQI scores from baseline by the study endpoint (P ≤ 0.01). The mean ISI scores in week 8 decreased significantly for the intervention group (P = 0.001) and also the placebo group (P < 0.01) when compared with baseline. Moreover, the use of hypnotic drugs in the intervention group was significantly reduced (P < 0.001), while in the control group was maintained at baseline level. ConclusionsIt seems that intranasal use of the multi-herbal preparation can be used to improve chronic insomnia and to reduce the dose of conventional hypnotic medications in insomniac patients.