Reduction In Sleep Onset Latency Research Articles

An evaluation of a stepped-care telehealth program for improving the sleep of autistic children

BackgroundSleep problems are prevalent in Autistic children, adversely affecting their development, well-being and quality of life. Traditional face-to-face behavioral interventions are hindered by accessibility. Using a single-case design, this study evaluated the efficacy of a stepped-care telehealth-delivered behavioral sleep intervention (TDBSI). MethodSeven Autistic children (aged 4–8) and their parents participated in a 12-week program consisting of baseline plus three sequential intervention phases: (1) self-directed online parent psychoeducation, (2) small group parent coaching via video conferencing, and (3) individualized parent coaching via video conferencing. Parent strategy selection and implementation fidelity were closely monitored and rated across intervention phases. Child sleep outcomes were assessed through daily parent-reported sleep diaries and the Children's Sleep Habits Questionnaire. ResultsFive of seven parents used online parent education to independently select antecedent strategies (e.g., sleep hygiene, stimulus control) and/or rewards that were appropriate for their child’s sleep and implemented them with high fidelity. This resulted in reductions in sleep onset latency, night wakings, early wakings, and bedsharing for their children. Parent implementation fidelity and child sleep outcomes were further improved for all participants with group or individualized coaching, and results were maintained at 12 weeks and six months post-intervention. ConclusionsTDBSIs show promise in addressing sleep difficulties in Autistic children, warranting further investigation and replication.

How do phases of the menstrual cycle affect sleep? A polysomnographic study of the EPISONO database.

Our study aimed to evaluate the impact of the menstrual cycle stages, especially menses, on sleep, inflammatory mediators, fatigue, anxiety, depression, and quality of life. We used data from the EPISONO study cohort, selecting 96 women who had undergone one-night polysomnography. The women were distributed in three groups according to the time point of the menstrual cycle on the polysomnography night: menses, mid/late follicular phase, and luteal phase. The volunteers completed questionnaires related to sleep quality, daytime sleepiness, insomnia, fatigue, anxiety, depression, and quality of life. Blood samples were collected to analyze interleukin 6, tumor necrosis factor-alpha, and C-reactive protein. Sleep efficiency was statistically higher in women in the mid/late follicular group (89.9% ± 9.6) compared to menstrual (83.0% ± 10.8) and luteal (83.7% ± 12.7) groups. The mid/late follicular group presented a statistically significant reduction in sleep onset latency (7.1 ± 7.1min) compared to the menstrual (22.3 ± 32.4min) and luteal groups (15.9 ± 14.7min). No statistical differences among the three groups were observed in other polysomnographic parameters, inflammatory mediators, daytime sleepiness, insomnia, fatigue, anxiety, depression, and quality of life. Our findings demonstrate that the mid/late follicular phase might be beneficial for women's sleep, although there were no statistically changes in inflammatory mediators among the groups.

Sleep architecture and Nusinersen therapy in children with Spinal Muscular Atrophy type 1

BackgroundSpinal muscular atrophy (SMA) is a severe neuromuscular disorder, the phenotype of the disease is caused by the mutation of the SMN1 (survival motor neuron 1) gene which encodes for the SMN protein. Innovative treatments for SMA have become available and the first molecule approved is Nusinersen, an antisense oligonucleotide that increases the production of SMN protein. Nusinersen has been shown to be associated with a significant motor improvement and an increase of the event‐free survival. For these reasons the aim of the present study is to assess if Nusinersen is able modify sleep architecture and microstructure and to improve sleep structure in these patients. MethodsSixteen patients affected by SMA1 were enrolled in the study (4 boys, 12 girls; median age 72.5 months, intelligence quotient range 24–84). All patients underwent complete nocturnal PSG before the start of the treatment trough intrathecal injections with Nusinersen (T0) and after the fifth infusion (day 180, T180). PSG recordings were visually scored and interpreted according to the indications of the American Academy of Sleep Medicine (AASM) and and microstructure by means of the Cyclic Alternating Pattern (CAP). ResultsAfter 6 months therapy we found a significantly reduced sleep latency and a significantly increased sleep efficiency. Regarding sleep microstructure parameters (CAP), we did not find any significant change after therapy however, it is worth mentioning that a moderate effect size was observed for the increase in CAP A3 index. ConclusionsWe observed short-term effects of Nusinersen on sleep with an improvement in sleep efficiency and reduction in sleep onset latency; regarding sleep microstructure, a moderate effect size was found for the number of CAP A3 subtypes that slightly increased, possibly indicating a slightly higher arousability. This finding points at a probably overall better sleep pattern organization associated with the treatment, but they need to be confirmed by larger studies with patients treated earlier in life and for a longer period.

A feasibility study of pre-sleep audio and visual alpha brain entrainment for people with chronic pain and sleep disturbance.

Chronic pain and sleep disturbance are bi-directionally related. Cortical electrical activity in the alpha frequency band can be enhanced with sensory stimulation via the phenomenon of entrainment, and may reduce pain perception. A smartphone based programme which delivers 10 Hz stimulation through flickering light or binaural beats was developed for use at night, pre-sleep, with the aim of improving night time pain and sleep and thereby subsequent pain and related daytime symptoms. The aim of this study was to assess the feasibility and give an indication of effect of this programme for individuals with chronic pain and sleep disturbance. In a non-controlled feasibility study participants used audio or visual alpha entrainment for 30 min pre-sleep each night for 4 weeks, following a 1 week baseline period. The study was pre-registered at ClinicalTrials.gov with the ID NCT04176861. 28 participants (79% female, mean age 45 years) completed the study with high levels of data completeness (86%) and intervention adherence (92%). Daily sleep diaries showed an increase compared to baseline in total sleep time of 29 min (p = 0.0033), reduction in sleep onset latency of 13 min (p = 0.0043), and increase in sleep efficiency of 4.7% (p = 0.0009). Daily 0-10 numerical rating scale of average pain at night improved by 0.5 points compared to baseline (p = 0.027). Standardised questionnaires showed significant within-participant improvements in sleep quality (change in median Global PSQI from 16 to 12.5), pain interference (change in median BPI Pain Interference from 7.5 to 6.8), fatigue (change in median MFI total score from 82.5 to 77), and depression and anxiety (change in median HADS depression score from 12 to 10.5 and anxiety from 13.5 to 11). Pre-sleep use of a smartphone programme for alpha entrainment by audio or visual stimulation was feasible for individuals with chronic pain and sleep disturbance. The effect on symptoms requires further exploration in controlled studies.

Changes in sleep performance and chronotype behaviour after vestibular rehabilitation in unilateral vestibular hypofunction.

This study aimed to investigate changes in sleep parameters and self-perceived sleep quality in unilateral vestibular hypofunction participants after vestibular rehabilitation. Forty-six unilateral vestibular hypofunction participants (before and after vestibular rehabilitation) along with a control group of 60 healthy patients underwent otoneurological examination, a one-week actigraphy sleep analysis and a series of self-report and performance measures. After vestibular rehabilitation, unilateral vestibular hypofunction participants showed a significant score decrease in the Pittsburgh Sleep Quality Index, a self-rated reliable questionnaire depicting sleep quality during the last month, as well as a reduction in sleep onset latency and an increase in total sleep time, indicating an objective improvement in sleep quality as measured by actigraphy analysis. However, after vestibular rehabilitation, unilateral vestibular hypofunction participants still showed statistically significant differences with respect to the control group in both self-rated and objective measurements of sleep quality. Vestibular rehabilitation may impact on sleep performance and chronotype behaviour, possibly by opposing long-term structural changes along neural pathways entangled in sleep activity because of the deafferentation of the vestibular nuclei.

Nutritional Modulation of Sleep Latency, Duration, and Efficiency: A Randomized, Repeated-Measures, Double-Blind Deception Study.

This study aimed to test the hypothesis that a novel nutritional blend composed of tryptophan, glycine, magnesium, tart cherry powder, and l -theanine enhances subjective and objective measures of sleep during free living conditions. In a randomized, repeated-measures crossover and double-blind deception design, participants ( n = 9 males and 7 females, age = 24 ± 3 yr, body mass = 69.8 ± 11.6 kg, stature = 170.8 ± 9.1 cm) completed a 3-d familiarization period, followed by 3-d intervention and placebo trials. Subjective Pittsburgh Quality Sleep Index, Core Consensus Sleep Diary, and Karolinska Sleepiness Scale survey tools, alongside objective actigraphy measures of sleep, were assessed, with daily nutritional intake, activity, and light exposure standardized between trials. Participants provided daily urine samples for assessment of targeted and untargeted metabolomes. The intervention trial reduced sleep onset latency (-24 ± 25 min; P = 0.002), increased total sleep time (22 ± 32 min; P = 0.01), and increased sleep efficiency (2.4% ± 3.9%; P = 0.03), while also reducing morning sleepiness ( P = 0.02). Throughout the study, 75% of participants remained blinded to sleep assessment as a primary outcome measure, with 56% subjectively indicating improved sleep during the intervention trial. Metabolomic analysis highlighted several significantly altered metabolomes related to sleep regulation between trials, inclusive of 6-sulfatoxymelatonin, d -serine, and l -glutamic acid. Data demonstrate that using the proposed blend of novel nutritional ingredients during free living conditions reduced sleep onset latency, increased total sleep duration, and increased sleep efficiency, leading to reduced perceptions of morning sleepiness. These effects may be mediated by the upregulation of key metabolites involved in the neurophysiological modulation of the sleep/wake cycle.

Cognitive behavior therapy for insomnia in cancer patients: a systematic review and network meta-analysis.

The aim of this study was to examine the most effective delivery format of cognitive behavioral therapy for insomnia (CBT-I) on insomnia in cancer patients. We searched five databases up to February 2021 for randomized clinical trials that compared CBT-I with inactive or active controls for insomnia in cancer patients. Outcomes were insomnia severity, sleep efficiency, sleep onset latency (SOL), wake after sleep onset (WASO), and total sleep time (TST). Pairwise meta-analyses and frequentist network meta-analyses with the random-effects model were applied for data analyses. Sixteen unique trials including 1523 participants met inclusion criteria. Compared with inactive control, CBT-I could significantly reduce insomnia severity (mean differences [MD]=-4.98 points, 95% confidence interval [CI]: -5.82 to -4.14), SOL (MD=-12.29 min, 95%CI: -16.48 to -8.09), and WASO (MD=-16.58 min, 95%CI: -22.00 to -11.15), while increasing sleep efficiency (MD=7.62%, 95%CI: 5.82% to 9.41%) at postintervention. Compared with active control, CBT-I could significantly reduce insomnia severity (MD=-2.75 points, 95%CI: -4.28 to -1.21), SOL (MD=-13.56 min, 95%CI: -18.93 to -8.18), and WASO (MD=-6.99 min, 95%CI: -11.65 to -2.32) at postintervention. These effects diminished in short-term follow-up and almost disappeared in long-term follow-up. Most of the results were rated as "moderate" to "low" certainty of evidence. Network meta-analysis showed that group CBT-I had an increase in sleep efficiency of 10.61%, an increase in TST of 21.98 min, a reduction in SOL of 14.65 min, and a reduction in WASO of 24.30 min, compared with inactive control at postintervention, with effects sustained at short-term follow-up. CBT-I is effective for the management of insomnia in cancer patients postintervention, with diminished effects in short-term follow-up. Group CBT-I is the preferred choice based on postintervention and short-term effects. The low quality of evidence and limited sample size demonstrate the need for robust evidence from high-quality, large-scale trials providing long-term follow-up data.

0087 Feasibility of examining component-specific effects of yogic breathing on self-report sleep metrics: A three-arm pilot RCT

Abstract Introduction Mind-body interventions (MBIs) continue to receive widespread interest for improving sleep disturbances. This study investigated the feasibility of using an automated electronic survey system in REDCap in the context of a fully remote clinical trial study to produce detailed measures of participant adherence, daily sleep quality, and associations with physiological outcomes captured by wearable devices. Methods Eighteen healthy participants (age 18-30 yrs, 12 female) were randomized to one of three 8-week long interventions: slow-paced breathing (SPB, N=5, 24.6 ± 2.1 years, 4 female), mindfulness (M, N=6, 23.7 ± 3.7 years, 4 female), or yogic breathing (SPB+M, N=7, 24.3 ± 3.1 years). Participants completed two weeks of daily sleep logs along with the Pittsburgh Sleep Quality Index (PSQI) prior to a virtual laboratory visit, which consisted of a 60-min intervention-specific training, including a 20-min guided practice, and subsequent tasks including experimental stress induction. Participants were then instructed to repeat their assigned intervention practice daily, selecting either the same or a similar guided audio as their initial training. After an initial video check-in appointment, participants received regular visual feedback of their data and completed weekly check-ins with the study team to improve adherence. At the end of the intervention period, participants again completed daily sleep logs and the PSQI, in addition to other outcome measures and a virtual laboratory visit. Data were analyzed using linear mixed models. Results Sleep log adherence was over 90% in all three groups. The groups were successfully distinguishable based on HRV-derived breathing and mindfulness ratings. For the SBP+M group only, there was a trend of reduced sleep onset latency (SOL, p=.093) and a significant increase in sleep efficiency (SE, p=.025). There were no significant changes in PSQI or other sleep log measures. More detailed analysis of timecourse across these measures is ongoing. Conclusion These findings support feasibility for a fully remote, semi-automated clinical trial study assessing component-specific effects of these MBIs on sleep in generally healthy young adults. Research evaluating MBIs for sleep in both clinical and nonclinical populations would benefit from similar study designs to examine intervention-specific components while increasing both scalability and quality control. Support (If Any) Pilot Research Grant, Osher Center for Integrative Medicine of Harvard Medical School and Brigham & Women’s Hospital; National Institutes of Health (5T32HL007901-22)

A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance.

This study examines the impact of cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) therapy for comorbid insomnia and sleep apnea on nocturnal sleep and daytime functioning. A partial factorial design was used to examine treatment pathways with CBT-I and PAP and the relative benefits of each treatment. One hundred eighteen individuals with comorbid insomnia and sleep apnea were randomized to receive CBT-I followed by PAP, self-monitoring followed by CBT-I concurrent with PAP, or self-monitoring followed by PAP only. Participants were assessed at baseline, PAP titration, and 30 and 90 days after PAP initiation. Outcome measures included sleep diary- and actigraphy-measured sleep, Flinders Fatigue Scale, Epworth Sleepiness Scale, Functional Outcome of Sleep Questionnaire, and cognitive emotional measures. A main effect of time was found on diary-measured sleep parameters (decreased sleep onset latency and wake after sleep onset; increased total sleep time and sleep efficiency) and actigraphy-measured sleep parameters (decreased wake after sleep onset; increased sleep efficiency) and daytime functioning (reduced Epworth Sleepiness Scale, Flinders Fatigue Scale; increased Functional Outcome of Sleep Questionnaire) across all arms (all P < .05). Significant interactions and planned contrast comparisons revealed that CBT-I was superior to PAP and self-monitoring on reducing diary-measured sleep onset latency and wake after sleep onset and increasing sleep efficiency, as well as improving Functional Outcome of Sleep Questionnaire and Flinders Fatigue Scale compared to self-monitoring. Improvements in sleep and daytime functioning were found with PAP alone or concomitant with CBT-I. However, more rapid effects were observed on self-reported sleep and daytime performance when receiving CBT-I regardless of when it was initiated. Therefore, concomitant treatment appears to be a favorable approach to accelerate treatment outcomes. Registry: ClinicalTrials.gov; Name: Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea (MATRICS); URL: https://clinicaltrials.gov/ct2/show/NCT01785303; Identifier: NCT01785303. Tu AY, Crawford MR, Dawson SC, etal. A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance. J Clin Sleep Med. 2022;18(3):789-800.

Eucaloric Balanced Diet Improved Objective Sleep in Adolescents with Obesity.

Background: A better understanding of the influence of energy balance on sleep in adolescents, particularly those with obesity, could help develop strategies to optimize sleep in these populations. The purpose of this study was to investigate sleep under ad libitum-vs-controlled diets adjusted to energy requirement (eucaloric) among adolescents with obesity and their normal weight controls. Methods: Twenty-eight male adolescents aged between 12 and 15 years, n = 14 adolescents with obesity (OB: BMI ≥ 90th centile) and n = 14 normal weight age matched controls (NW), completed an experimental protocol comprising ad libitum or eucaloric meals for three days, in random order. During the third night of each condition, they underwent in home polysomnography (PSG). Results: An interaction effect of energy intake (EI) was detected (p < 0.001). EI was higher during ad libitum compared to the eucaloric condition (p < 0.001) and in OB compared to NW (p < 0.001) in the absence of any substantial modification to macronutrient proportions. Analyses of energy intake distribution throughout the day showed a significant interaction with both a condition and group effect during lunch and dinner. Sleep improvements were noted in OB group during the eucaloric condition compared to ad libitum with reduced sleep onset latency and N1 stage. Sleep improvements were correlated to reduced EI, especially during the evening meal. Conclusion: Simply adjusting dietary intake to energy requirement and reducing the energy proportion of the evening meal could have therapeutic effects on sleep in adolescents with obesity. However, positive energy balance alone cannot justify worsened sleep among adolescents with obesity compared to normal weight counterparts.

Pre-sleep social media use does not strongly disturb sleep: a sleep laboratory study in healthy young participants

ObjectiveSleep is critical for our mental health and optimal cognitive functioning. Social media use is increasingly common and suspected to disturb sleep due to increasing bedtime arousal. However, most studies rely on self-reported sleep. MethodsWe tested the effects of 30 min social media use on arousal and subsequent sleep in the sleep laboratory in 32 healthy young volunteers. Effects of blue-light were excluded in this study. We compared it to 30 min progressive muscle relaxation (PMR) and neutral sleep in a within-subject design. ResultsThirty minutes of social media use immediately before sleep did not significantly increase arousal and did neither disturb objective nor subjective sleep. After social media use, participants only spent less time in sleep stage N2. In contrast, PMR had the expected positive effects on pre-sleep arousal level indicated by reduced heart rate. In addition, PMR improved sleep efficiency, reduced sleep onset latency, and shortened the time to reach slow-wave sleep compared to a neutral night. Oscillatory power in the slow-wave activity and spindle bands remained unaffected. ConclusionSocial media use before sleep (controlling for effects of blue-light) had little effect on bedtime arousal and sleep quality than what was previously expected. The most notable effect appears to be the additional time spent engaging in social media use at bedtime, potentially keeping people from going to sleep. As wake up-time is mostly determined externally, due to school or working hours, limiting personal media use at bedtime—and especially in bed—is recommended to get sufficient hours of sleep.

Alteration of sleep homeostasis and cognitive impairment in apneic obese adolescents

To evaluate specific features of sleep pattern and neurocognitive performance in OSA obese adolescents to correlate sleep macrostructural parameters and phasic events (K-complexes, KCs; and sleep spindles, SSs) with cognitive functioning in these individuals. Polysomnography was recorded from 25 male apneic obese patients (15–17 years), 20 age- and sex-matched non-apneic obese and 15 lean adolescents. KCs and SSs were identified during stage 2 non-rapid eye movement sleep (N2) and characteristics were evaluated. Furthermore, all participants underwent cognitive performance assessment using a battery of neurocognitive tests. Participant’s data, macro- and microstructural sleep variables and cognitive measures were compared. Finding data were analyzed using descriptive and regression analyses. Differences were reliable at p < 0.05. Compared to both controls, the OSA obese group had significantly reduced sleep onset latency (p = 0.061), slow-wave sleep (SWS) and rapid eye movement (REM) sleep (p < 0.01 for both), but increased N1–N2 stage duration (p < 0.01), the appearance of KCs during apnea and after apnea episodes (DE-KCs and AE-KCs, respectively), reduced spontaneous KCs (SN-KCs) number and periodicity, and lowered amplitude of apnea evoked KCs. SSs activity was an atypical increased in the OSA group. SWS, REM sleep, minimal SaO2, DE-KCs, AE-KCs, and SSs, as well as SN-KCs number, were predictors of cognitive functioning (attention, memory, thinking, speech) changes in OSA adolescents. Together, the above results provide some evidence for impairment in sleep homeostatic mechanisms, when OSA and obesity are comorbid, and provide novel insights into the relationship between sleep microstructure disruption and waking cognitive functioning in these adolescents.

Hot-water bathing before bedtime and shorter sleep onset latency are accompanied by a higher distal-proximal skin temperature gradient in older adults.

Passive body heating in controlled settings could shorten sleep onset latency (SOL). The hypothesized mechanism is vasodilation-induced heat loss before bedtime. However, this evidence is based on small sample-sized studies in specific populations. Thus, we analyzed the association of hot-water bathing and its before-bedtime timing with SOL and heat loss in a large study population of older adults. We conducted a longitudinal analysis using repeated measurements of hot-water bathing and sleep among 1,094 older adults (mean age, 72.0 years). SOL was recorded using actigraphy and self-reported sleep estimates and was categorized into conditions (intervals of 1-60, 61-120, 121-180, and > 181 minutes between hot bath and bedtime) and compared with the control condition of no bathing. The heat-loss indicator, distal-proximal skin temperature gradient, was examined in the same categorization. Mixed-effects linear regression models suggested that the bathing conditions of 61-120 minutes and 121-180 minutes showed significantly shorter log-transformed actigraphic SOL by 0.23 log-minutes (95% confidence interval (CI), 0.03-0.42) and 0.32 log-minutes (95% CI, 0.09-0.56), shorter self-reported SOL by 0.16 log-minutes (95% CI, 0.02-0.30) and 0.18 log-minutes (95% CI, 0.01-0.35), and higher distal-proximal skin temperature gradient for 30 minutes before bedtime by 0.49°C (95% CI, 0.22-0.75) and 0.51°C (95% CI, 0.20-0.83), respectively, independent of potential confounders. Hot-water bathing before bedtime is significantly associated with shorter SOL and higher distal-proximal skin temperature gradient among the large-scale older population. This finding could enhance the generalizability of hot-water bathing habits for ameliorating sleep initiation difficulty.

Effects of Tangerine Essential Oil on Brain Waves, Moods, and Sleep Onset Latency.

Tangerine (Citrus tangerina) is one of the most important crops of Thailand with a total harvest that exceeds 100,000 tons. Citrus essential oils are widely used as aromatherapy and medicinal agents. The effect of tangerine essential oil on human brain waves and sleep activity has not been reported. In the present study, we therefore evaluated these effects of tangerine essential oil by measurement of electroencephalography (EEG) activity with 32 channel platforms according to the international 10–20 system in 10 male and 10 female subjects. Then the sleep onset latency was studied to further confirm the effect on sleep activity. The results revealed that different concentrations, subthreshold to suprathreshold, of tangerine oil gave different brain responses. Undiluted tangerine oil inhalation reduced slow and fast alpha wave powers and elevated low and mid beta wave powers. The subthreshold and threshold dilution showed the opposite effect to the brain compared with suprathreshold concentration. Inhalation of threshold concentration showed effectively decreased alpha and beta wave powers and increased theta wave power, which emphasize its sedative effect. The reduction of sleep onset latency was confirmed with the implementation of the observed sedative effect of tangerine oil.

Effects of forehead cooling and supportive care on menopause-related sleep difficulties, hot flashes and menopausal symptoms: a pilot study

ABSTRACT Objective/Background This pilot study explored the efficacy of a novel forehead cooling device for perceived sleep difficulties and hot flashes in menopausal-age women. Participants 20 women (55.1 ± 4.2 years; 19 post-menopausal) with insomnia symptoms and self-reported two or more hot flashes per day. Methods Participants completed daily assessments of sleep and hot flashes (via diaries) across 1 baseline week and 4 weeks of open-label, in-home, nightly treatment with a forehead cooling device (15–18°C) along with sleep hygiene instructions. They also completed ratings of insomnia and menopausal symptoms using standardized questionnaires. Results Women reported reductions in sleep onset latency (SOL), wakefulness after sleep onset (WASO), and nocturnal hot flash severity during the first week of treatment (SOL: 25.7 ± 18.4 min; WASO: 36.3 ± 27.3 min; hot flash severity: 3.0 ± 2.8) compared with baseline (SOL: 38 ± 26.3 min; WASO: 52.2 ± 35.6 min; hot flash severity: 6.8 ± 3.7), with further improvements after 2–4 weeks of use (p < .001). There were also clinically meaningful reductions in insomnia severity and hot flash-related daily interference and lower psychological and physical symptom scores on the Greene climacteric scale after treatment (all p’s<0.001). Conclusions This exploratory, naturalistic, pilot study shows that nightly use of a forehead cooling device produces improvements in self-reported sleep and reductions in insomnia, hot flash, and other menopausal, symptoms. Controlled studies are warranted to determine the role of this therapy in the management of sleep difficulties and menopausal symptoms in women. Further mechanistic studies are needed to understand the physiological impact of forehead cooling on sleep and menopausal symptoms.

Optimisation and Validation of a Nutritional Intervention to Enhance Sleep Quality and Quantity.

Background: Disturbed sleep may negatively influence physical health, cognitive performance, metabolism, and general wellbeing. Nutritional interventions represent a potential non-pharmacological means to increase sleep quality and quantity. Objective: (1) Identify an optimal suite of nutritional ingredients and (2) validate the effects of this suite utilising polysomnography, and cognitive and balance tests. Methods: The optimal and least optimal combinations of six ingredients were identified utilising 55 male participants and a Box–Behnken predictive model. To validate the model, 18 healthy, male, normal sleepers underwent three trials in a randomised, counterbalanced design: (1) optimal drink, (2) least optimal drink, or (3) placebo were provided before bed in a double-blinded manner. Polysomnography was utilised to measure sleep architecture. Cognitive performance, postural sway, and subjective sleep quality, were assessed 30 min after waking. Results: The optimal drink resulted in a significantly shorter sleep onset latency (9.9 ± 12.3 min) when compared to both the least optimal drink (26.1 ± 37.4 min) and the placebo drink (19.6 ± 32.0 min). No other measures of sleep, cognitive performance, postural sway, and subjective sleep quality were different between trials. Conclusion: A combination of ingredients, optimised to enhance sleep, significantly reduced sleep onset latency. No detrimental effects on sleep architecture, subjective sleep quality or next day performance were observed.

Treating subclinical and clinical symptoms of insomnia with a mindfulness-based smartphone application: A pilot study

Background/objectivesEmerging research suggests that face-to-face group mindfulness-based therapies are an effective intervention for insomnia. This pilot study examined the effectiveness of a mindfulness-based smartphone application for improving objectively-measured sleep, self-reported sleep, insomnia severity, pre-sleep arousal and daytime mood. MethodA community sample of 23 adults with subclinical to moderately severe symptoms of insomnia were randomized to either a mindfulness or progressive muscle relaxation (PMR) smartphone application for 40 or 60 days. Objective sleep outcomes assessed using actigraphy, and self-report measures of total wake time, cognitive and somatic pre-sleep arousal, and daytime positive and negative affect were assessed for 14 nights at baseline and post-intervention. Insomnia severity was recorded at baseline and post-intervention. ResultsA greater reduction in sleep onset latency was observed in the mindfulness group over time, relative to the PMR group. The mindfulness group also reported medium effect size improvements for sleep efficiency. No significant interaction effects were found for self-reported sleep measures, however, main effects of time were found for both groups for total wake time, insomnia severity, cognitive pre-sleep arousal, and daytime positive and negative affect. ConclusionsThese preliminary findings suggest that both mindfulness and PMR smartphone applications have the potential to improve symptoms of insomnia. In particular, this mindfulness-based smartphone application may improve sleep onset latency and reduce the duration of night-awakenings. Further research exploring digital therapeutics as a self-help option for those with insomnia is needed.

Effects of a forehead cooling device in veterans with chronic insomnia disorder and co-morbid medical and psychiatric conditions: a pilot study.

While forehead cooling has been studied in patients with insomnia in the absence of comorbid medical/psychiatric disorders, it has never been evaluated in patients with insomnia in the presence of co-morbid medical/psychiatric disorders. Veterans with chronic insomnia disorder and co-morbid medical and psychiatric conditions received 4-week open-label, in-home, nightly treatment with a forehead cooling device (14-16 °C) along with personalized sleep hygiene following baseline assessments. Pre- and post-treatment, participants completed the Insomnia Severity Index (ISI), the Generalized Anxiety Disorder 7-item scale (GAD-7), and the Patient Health Questionnaire 9-item scale (PHQ-9). Participants recorded daily sleep and anxiety/arousal symptoms. Of 24 veterans (20 men, 42.2 ± 9.5 years), 17 (71%) had marked insomnia severity improvement (a decrease of > 8 on the ISI) and 10 (42%) participants scored 7 or below on the ISI at post-treatment reflecting remission. Participants reported reductions in sleep onset latency (SOL) (F = 12.9, p < 0.001), and wakefulness after sleep onset (WASO) (F = 8.4, p < 0.001) across treatment. They also had significant reductions in insomnia severity (t = 10.04, p < 0.001), anxiety (t = 3.59, p = 0.002), and depression (t = 7.75, p < 0.001) from pre- to post-treatment. This pilot study shows that 4-week nightly use of a forehead cooling device produces improvements in insomnia, anxiety, and depressive symptoms in veterans with chronic insomnia disorder and co-morbid medical and psychiatric conditions. Controlled studies are warranted to determine the role of this therapy in the management of insomnia in veterans. Not required as a small sample size feasibility study.

0916 The Use of Immersive Virtual Reality and Slow Breathing to Enhance Relaxation and Sleep in Adolescents

Abstract Introduction Sleep disturbances frequently emerge during adolescence amongst profound, normative, sleep maturation and biopsychosocial changes. Factors like stress, worry or rumination may make falling asleep and maintaining sleep more difficult. Here, we evaluate the efficacy of a novel intervention based on virtual reality (VR) and slow breathing to promote bedtime relaxation and facilitate sleep in high-school adolescents. Methods Twenty-nine 16-18 year-old adolescents with (N=9, 6 girls) and without (N=20, 11 girls) sleep difficulties underwent two counterbalanced in-lab relaxation and baseline polysomnography (PSG) nights. For the relaxation condition, immediately preceding bedtime, participants were engaged in slow diaphragmatic breathing (to promote physiological downregulation) whilst passively experiencing a relaxation immersive VR environment, designed to promote cognitive relaxation/distraction (20min). On the baseline night, participants engaged in quiet activities (e.g., reading a book) before bedtime (20min). Results The VR intervention resulted in a significant immediate increase in perceived relaxation and reduced worry (p&amp;lt;0.05). Also, heart rate dropped (~5bpm) in the pre-to-post intervention (p&amp;lt;0.05), while no significant change in heart rate was evident before and after the time spent in quiet activities on the baseline night. PSG-defined sleep onset latency was shorter (~6min reduction) and sleep efficiency was greater (~3% increase) on the VR relaxation night compared to the baseline night (p&amp;lt;0.05). In addition, baseline sleep onset latency was related to the magnitude of the baseline-to-relaxation reduction in sleep onset latency in participants (R2=0.70; p&amp;lt;0.01). There was no apparent difference in responses to the VR intervention between adolescents with or without insomnia. Conclusion Our data highlight the potential for combining cognitive relaxation/distraction strategies, using immersive VR technology and physiological downregulation, to promote bedtime relaxation and improve overall sleep quality in adolescents. Further research is needed to evaluate the feasibility and effectiveness of such interventions over time. Support National Heart, Lung and Blood Institute (NHLBI) R01HL139652 (to MdZ)

Lemborexant in insomnia disorder: a profile of its use

Lemborexant (Dayvigo™), a dual orexin receptor antagonist, is an effective and well-tolerated treatment option for adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. In phase 3 clinical trials, oral lemborexant 5 or 10 mg once nightly significantly reduced sleep onset latency (SOL) and wake-after-sleep onset (WASO), and improved sleep efficiency (SE). Lemborexant was also associated with reductions in patient-reported fatigue and insomnia severity, and was well tolerated through 12 months of treatment. In special safety studies, lemborexant did not increase the auditory awakening threshold or cause next-day postural instability, and was not associated with rebound insomnia, withdrawal symptoms, or clinically meaningful impairment of next-day memory or driving performance.