0558 Transcranial Alternating Electrical Stimulation in Subjects with Insomnia Symptoms: A Randomized Controlled Study

Transcranial alternating current stimulation in subjects with insomnia symptoms: A randomized, double-blind and controlled study.

Introduction: Patients with inflammatory bowel disease (IBD) have a higher prevalence of subjective sleep disturbances and this has been associated with subclinical inflammation and risk for active disease at 6 months. Although these associations are of interest, objective sleep assessment has not been performed in ulcerative colitis (UC) patients. Methods: This is a prospective assessment of adult UC patients in clinical remission who underwent surveillance colonoscopy and wore a wrist actigraphy watch for 7 days prior to colonoscopy. Subjective sleep quality and quality of life were assessed using the Pittsburgh sleep quality index (PSQI) and the short inflammatory bowel disease questionnaire (SIBDQ). Objective sleep parameters assessed were: sleep onset latency (SOL), total sleep time (TST), wake after sleep onset (WASO), sleep efficiency (SE). Endoscopy and pathology were reviewed for all patients. Statistical analysis included a Fischer’s exact test, Student’s t-test, and Pearson’s correlation coefficient. Results: Fourteen UC patients participated in the study, 9 (64%) were male, the mean age was 44.7 years (standard deviation [SD] 14.2 years), 9 patients (64.3%) were described as having pancolitis, and the mean duration of disease was 16.3 years (SD 11.4 years). A greater number of patients had abnormal objective vs. subjective sleep measures (8 (57.1%) vs. 4 (38.6%)). The mean total time in bed was 481 minutes (SD 72.4 minutes) and TST of 346 minutes (SD 112 minutes), with a calculated SE of 71.3% (SD 6%), SOL 28.5 minutes (SD 22.1 minutes), WASO 40.7 minutes (SD 17.4 minutes), and number of awakenings 30.8 (SD 12.8). Five (35.7%) patients had inflammation present on endoscopic assessment. Patients with inflammation were older (55 years vs. 39 years; p=0.04), had longer disease duration (25.8 years vs. 11 years; p=0.01), and had higher PSQI scores (7.2 vs. 2.9; p<0.01). There were no differences in objective sleep parameters between patients with inflammation and those without inflammation. There was a trend towards higher quality of life scores in patients without inflammation (p=0.08). There was an excellent correlation in all patients between SIBDQ scores and PSQI scores (r=-0.74), WASO (r=+0.64), and number of awakenings (r=+0.61). Conclusion: This is the first description of patients with UC using wrist actigraphy to assess sleep quality. There were no statistical differences in objective sleep measures between patients with histologic inflammation and those without inflammation. Despite all patients being in clinical remission, a large percentage had disrupted sleep. There was excellent correlation between quality of life and PSQI scores and objective sleep measures; WASO and average number of awakenings.

Efficacy and safety of acupuncture for the treatment of insomnia in breast cancer patients: A systematic review and meta-analysis

Introduction The prevalence of insomnia complaints in older adults is 30–48%, compared to 10–15% in the general population. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a first-line, non-pharmacological sleep treatment for Insomnia. However, the relative impact of Behavioral (BT) and Cognitive (CT) components compared to that of CBT-I in older adults is unknown. Methods 128 older adults with insomnia were randomized to receive CBT-I, BT, or CT. Sleep diaries and the Insomnia Severity Index (ISI) were collected pre- and post-treatment and at a 6-month follow-up. We conducted split-plot linear mixed models with age and sex as covariates to assess within and between subject changes to test effects of group, time, and their interaction on ISI, sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), sleep efficiency (SE), and percent of treatment responders (ISI decrease&amp;gt;7) and remitters (ISI&amp;lt;8). Effect size (d) was calculated by dividing the difference between means by the root-mean-squared error of the mixed effects model. Results All treatments lead to a significant improvement across outcome measures at post-treatment (p’s&amp;lt;0.001) and 6-months (p’s&amp;lt;0.01), with the exception of TIB, response, and remission. For TIB, there was a significant Group x Time interaction (p&amp;lt;0.001): while all treatments significantly reduced TIB post-treatment relative to baseline, CBT-I (p&amp;lt;0.001,d=-2.26) and BT (p&amp;lt;0.001,d=-1.59) performed significantly better than CT (p=0.003, d=-0.68). In contrast, at 6-months CBT-I (p&amp;lt;0.001,d=-1.16) performed significantly better at reducing TIB than CT (p=0.195,d=-0.24) or BT (p=0.023,d=-0.61) relative to baseline. There was also a non-significant trend for a Group x Time interaction for remission status (p=0.062). Whereas, the percentage of remitters within all groups post-treatment did not differ from chance (p&amp;gt;0.234), at 6 months, the percentage of remitters was significantly higher than chance in CBT-I (73.63%,p=0.026) and BT (78.08%,p=0.012), but not CT (47.85%,p=0.826). There were no other significant time or interaction effects (all p&amp;gt;0.05). Conclusion CBT-I and its components are effective in improving subjective insomnia symptoms in older adults. Evidence suggests CBT-I may be superior to either CT or BT alone in improving TIB in older adults. Support (if any) NIMHR01MH101468; MIRECC at VAPAHCS

Introduction Sleep disturbance remains common in patients with a history of Restless Legs Syndrome (RLS), even after RLS symptoms are sufficiently controlled with medication. Multiple potential causes for treatment-refractory sleep disturbance exist, including conditioned insomnia and poor sleep habits due to chronic RLS-related sleep disturbance, and comorbid medical and psychiatric illness. We conducted a placebo-controlled crossover trial to examine the efficacy of suvorexant in improving sleep quality and quantity in patients with well-controlled RLS and persistent insomnia. Methods In this double-blind, randomized, placebo-controlled crossover trial, 34 patients with well-controlled RLS were randomized to placebo or suvorexant (10-20 mg) for 6 weeks, followed by a 2-week washout and then the opposite treatment. Well-controlled RLS was defined as a score of less than 15 on the International Restless Legs Syndrome Study Group Rating Scale (IRLS) and Insomnia Disorder was defined by a self-reported combined Sleep Onset Latency (SOL) and Wake After Sleep Onset (WASO) of greater than 45 minutes and a Total Sleep Time (TST) of less than 7 hours. The primary outcome was actigraphically-derived TST, and secondary outcomes were Insomnia Severity Index (ISI) score and actigraphically-derived WASO. Data for all sleep metrics were collected at baseline and for the last two weeks of each treatment period. Results There were no significant improvements in actigraphically-derived TST (p = 0.58) or WASO (p = 0.99) while taking suvorexant compared to placebo. However, there was a significant reduction in insomnia symptoms, measured by the ISI, while taking suvorexant (p = 0.03). Moreover, exploratory analyses revealed a significant increase in self-reported TST (p = 0.01) and a significant reduction in nightly variability in TST (p = 0.03) while taking suvorexant. The most commonly reported side effect of suvorexant was fatigue (29.4%). Conclusion Though we did not observe a significant change between treatments in our primary endpoint of actigraphically-derived TST, our secondary and exploratory findings revealed promising support for suvorexant’s positive impact on self-reported quantity and quality of sleep in people with well-controlled RLS who continue to suffer from insomnia. Support (if any) Funded by an investigator-initiated grant from Merck Pharmaceuticals.

IntroductionDigital CBTI programs are effective at treating symptoms of insomnia. They also have the potential to increase treatment reach, convenience, and affordability for patients, and to reduce long wait times for behavioral sleep medicine providers. The COVID-19 pandemic has instigated an increased reliance on the use of technology for many. Thus, this study evaluates middle aged and older adults before and during the COVID-19 pandemic to assess: (1) differences in treatment modality preference (digital vs. therapist-led CBTI) and (2) sleep-related predictors of treatment modality preference.MethodsParticipants were older adults (N=229, 74% female, mean age=63.14) who were enrolled in the RCT of the Effectiveness of Stepped-Care Sleep Therapy in General Practice (RESTING) study. At baseline, participants rated if they would prefer to access CBTI digitally or with a CBTI therapist, either in person or via telemedicine. After March 2020, in person was no longer listed as an option. Participants completed the Insomnia Severity Index (ISI) and a two-week sleep diary that allowed for an assessment of total sleep time (TST), sleep onset latency (SOL), and wake after sleep onset (WASO). Analyses compared responses to these items from participants completing assessments before March 2020 (Pre-Covid; n=74, 65% female, mean age=62.52) and after March 2020 (During-Covid; n=155, 78% female, mean age=63.44).ResultsPre-Covid, 26% of participants preferred digital treatment, 47% of participants preferred a therapist-led intervention, and 27% did not express a preference. During-Covid, 35% of participants preferred digital treatment, 32% of participants preferred a therapist-led intervention, and 32% did not express a preference. This difference was statistically significant (c2=4.24, p=0.04). Responses were not significantly different between the first six months and the most recent six months of the pandemic (p=0.60). None of the sleep measures (ISI, TST, SOL, WASO) were associated with treatment modality preference in the full sample, Pre-Covid, or During-Covid.ConclusionThe COVID-19 pandemic was associated with increased preference for digital CBTI among patients who are 50 and older, regardless of insomnia severity. Findings suggest that digital CBTI may be an acceptable treatment to many individuals with insomnia, thus increasing its dissemination potential.Support (If Any)R01AG057500 and T32MH019938

ObjectiveThe purpose of this study was to determine, for the first time, whether the application of a self-management program with global postural re-education (GPR) influences stress and sleep quality in female health science students.MethodsIn this randomized controlled trial pilot study, forty-one female health science students were randomized into a control group (n=21) and an intervention group (n=20). Participants underwent 8 weeks of self-management with and without GPR, after familiarization and therapy training. Outcomes included the State-Trait Anxiety Inventory (STAI) questionnaire and cortisol levels in saliva measured with the “CORTISOL Saliva ELISA SA E-6000” kit. Sleep quality was measured with the Pittsburgh Sleep Quality Index (PSQI) and a Sleep Diary; total sleep time (TST), sleep onset latency (SOL), wakefulness after sleep onset (WASO), sleep efficiency (SE), and perceived sleep quality or satisfaction were assessed using the Likert scale.ResultsAfter self-treatment with GPR, participants in the intervention group showed lower cortisol levels compared to the control group (p = 0.041). Additionally, the intervention group demonstrated statistically significant improvements in sleep quality according to their PSQI (p = 0.010), STAI (p = 0.043), SOL (p = 0.049), and SE (p = 0.002).ConclusionThis study shows that self-management through GPR helps reduce stress and improve sleep quality in female health science students.Clinical Trial Registrationhttps://clinicaltrials.gov/, identifier NCT05488015.

ABSTRACTThe relevance of altered rest-activity rhythm (RAR) and light exposure rhythm (LER) in insomnia patients under natural conditions remains unclear. The aim of this study was to compare the parametric and nonparametric circadian variables of RAR and those of LER under natural conditions between insomnia patients and normal controls (NC) in a community-dwelling setting. The relationship of the nonparametric variables with sleep quality was also explored in both groups. Participants above 18 years old were recruited from three Public Health Centers in a rural area of Korea. Actigraphy (Actiwatch 2; Philips Respironics, Murrysville PA, USA) recording was conducted for 7 days. Subjects were eligible for our study if they had an insomnia disorder (ID) for at least 1 month. Actigraphy data of 78 normal control (NC) subjects (Age, 55.95 ± 13.22 years) and 104 patients with insomnia disorder (ID) (Age, 62.14 ± 12.34 years) were included for the analysis. Acrophases and amplitudes of RAR and LER were estimated using cosinor analysis. Interdaily stability (IS), intradaily variability (IV), and relative amplitude (RA) of these rhythms were determined using nonparametric methods. Parametric cosinor and nonparametric variables of RAR and LER were compared between the NC and ID groups. Generalized linear models (GLMs) were applied to evaluate the main effects of group and each nonparametric variable as well as a group by each variable interaction on the sleep onset latency (SOL), sleep efficiency (SE), and wake after sleep onset (WASO) reflecting sleep quality. Among sleep parameters, the ID group showed significantly lower SE and greater WASO than the NC group. There were no significant differences in the acrophase and amplitude of RAR and LER between the two groups. There were no significant differences in IV, IS, and RA of RAR and LER between the two groups either. GLMs for RAR revealed a significant interaction between the group and IS on the SOL (β = −46.39, p < 0.01), indicating a negative relationship of the IS with SOL in ID unlike its positive relationship in NC. There were no significant main effects of IV on the SOL, SE, and WASO, but significant main effects of RA on the SE and WASO (β = 63.65 and β = −221.43, respectively, p < 0.01). GLMs for LER revealed no significant main effects of IS, IV or RA on the SOL, SE, and WASO, but significant interactions between group and RA on the SE and WASO (β = 56.17 and β = −171.93, respectively, p < 0.05), indicating a stronger positive relationship of the RA with SE in ID compared to NC, and a negative relationship of the RA with WASO in ID, unlike its positive relationship in NC. Although our study did not reveal group differences in circadian variables of RAR and LER, it suggested that the regularity of RAR could be positively associated with sleep initiation, while the robustness of LER could be positively associated with sleep maintenance in insomnia patients.

To quantify the contribution of sleep onset latency (SOL), wake after sleep onset (WASO), and wake after sleep offset (WASF) to the discrepancy between total recording time (TRT) and total sleep time (TST) in home-based polysomnography (PSG) using patient-activated and deactivated monitoring devices. This observational study enrolled patients with a high pretest probability of obstructive sleep apnea who underwent unattended home-based PSG. We measured the duration of SOL, WASO, and WASF to quantify the discrepancy between TRT and TST. TRT was defined as the interval from device activation to deactivation by the patients. SOL represented the time from device activation to the first epoch of any sleep, WASO was the total amount of time spent awake after the sleep onset epoch until the last epoch of any sleep, and WASF was defined as the time from the last epoch of any sleep until the patient-initiated device deactivation. We also assessed differences in the apnea-hypopnea index between home-based PSG and type 3 sleep studies by reanalyzing home-based PSG recordings as simulated type 3 studies after omitting type 2 signals. A total of 78 patients were included in the study. The mean TRT exceeded the mean TST by 19%, with TRT at 457 ± 78 minutes and TST at 383 ± 68 minutes. The mean difference between TRT and TST was 74 ± 53 minutes, attributed to SOL (30%), WASO (45%), and WASF (25%). There was considerable variability in the difference between TRT and TST among study participants, ranging from as little as 14 minutes to as much as 233 minutes. The mean apnea-hypopnea index in simulated type 3 studies (41 ± 29 events/h) was, on average, 23% lower than the mean apnea-hypopnea index recorded in home-based PSG (53 ± 30 events/h) (P < .001). There was significant variability in the gap between TRT and TST among patients at increased risk of obstructive sleep apnea undergoing unattended home-based PSG. WASO was identified as the largest contributor to this discrepancy, with notable contributions from SOL and WASF. Additionally, simulated type 3 studies underestimated the true apnea-hypopnea index compared to type 2 studies. Nikolopoulos A, Tatsis K, Tselepi C, etal. Quantifying the sources of discrepancy between total recording time and total sleep time in home sleep apnea testing: insights from home-based polysomnography. J Clin Sleep Med. 2025;21(6):1065-1072.

Background/Objectives: Sleep health impacts numerous domains of human health, and sleep deprivation has emerged as a significant public health concern. Multiple types of dietary nutrient supplementation, dietary intake, and the use of nutritional supplements to enhance sleep quality are recognized as effective methods to improve sleep quality. Methods: We aim to systematically evaluate the efficacy of dietary supplement interventions in sleep quality improvement across populations with sleep disorders and healthy individuals. We conducted a comprehensive literature search across PubMed, Web of Science, CNKI, ScienceDirect, Wiley, and CVIP databases. Sleep evaluation metrics included the Pittsburgh Sleep Quality Index (PSQI), sleep efficiency (SE), sleep latency (SL), total sleep time (TST), wake after sleep onset (WASO), and number of awake after sleep onset (NASO). Meta-analysis procedures were executed in Review Manager 5.3 and Stata 17.0, with heterogeneity quantified via I2 statistics. Results: This study, in total, included 28 randomized controlled trials. This meta-analysis’s results suggest dietary interventions significantly improved sleep outcomes: reduced PSQI (MD: −0.70, 95% CI: −1.37 to −0.03, p < 0.05), increased SE (+2.58 min, 95% CI: 2.01–3.16, p < 0.00001), prolonged TST (SMD: +0.23, 95% CI: 0.04–0.43, p < 0.05), and shortened SL (SMD: −0.24, 95% CI: −0.37 to −0.10) and WASO (SMD: −0.30, 95% CI: −0.48 to −0.12) (both p < 0.001). NASO showed a marginal reduction (MD: −1.57, 95% CI: −3.16 to 0.02, p = 0.05). Conclusions: These findings suggest that tryptophan, vitamin D, omega-3, zinc, and antioxidants may enhance sleep quality by decreasing SL, and WASO increases SE and extends TST, respectively.

Introduction Sleep quality has a significant bearing on disease. A better understanding of sleep quality may help identify opportunities to improve patient-reported outcomes (PROs) in persons with heart failure with preserved ejection fraction (HFpEF). We aimed to explore the association between sleep and PROs in patients clinically diagnosed with HFpEF. Methods Cross-sectional study of 22 participants (71.2±7.2 years, 95% male, 86.4% white) with HFpEF, recruited from a heart failure (n=14) and sleep clinic (n=8). Sleep disordered breathing was measured objectively using one-night in-home obstructive sleep apnea (OSA) testing (ApneaLink). Actigraphy (7 days) was used to assess sleep duration, efficiency, and wake after sleep onset (WASO). Subjective sleep measures included the Insomnia Severity Index (ISI), Epworth Sleepiness scale (ESS), and Pittsburgh Sleep Quality Index (PSQI). PROs included functional status (Functional Outcomes Sleep Questionnaire [FOSQ]), depression (PROMIS Depression), fatigue (PROMIS Fatigue), and heart failure specific quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ]; overall summary score [KCCQ-os] and clinical summary score [KCCQ-cs]). The KCCQ-cs includes physical function and symptom scores to corresponds with NYHA Classification. Results Fifty percent of the participants had poor sleep quality (PSQI &amp;gt;5) and 2 (9.1%) had ISI scores &amp;gt;14. The majority (64%; n=14) had OSA; 10 currently on OSA therapy. Mean oxygen desaturation index (ODI) was 20.8±17.8. Mean actigraphy data indicated poor sleep (sleep duration 302±116 minutes, sleep efficiency 70.0±18.6%, and WASO 52±28 minutes) despite only 5 (22.7%) participants reporting excessive daytime sleepiness (ESS&amp;gt;10). Greater insomnia symptom severity was associated with lower heart failure specific quality of life (KCCQ-os) and functional status, and, greater fatigue and depression (all p-values &amp;lt;.05). FOSQ was negatively associated with PSQI (r= -.710, p= &amp;lt;.001) and positively with sleep efficiency (r=.496, p=.026). The KCCQ-cs was positively associated with sleep duration (r=.496, p=.026) and negatively but not significantly associated with ODI (r= -.453, p=.07). Conclusion Impaired sleep and OSA are highly prevalent in patients with HFpEF and both are adversely associated with PROs. Goals to improve sleep is important for effective symptom management and for potential improvements in PROs. Support American Nurses Foundation, Preventative Cardiovascular Nurses Association

Sleep diary and actigraphy assessments of insomnia symptoms in patients with fibromyalgia (FM) are often discrepant. We examined whether opioid dose and age interact in predicting magnitude or direction of discrepancies. Participants (N=199, M=51.5years, SD=11.7) with FM and insomnia completed 14days of diaries and actigraphy. Multiple regressions determined whether average opioid dose and its interaction with age predicted magnitude or direction of diary/actigraphy discrepancies in sleep onset latency (SOL), wake after sleep onset (WASO) and sleep efficiency (SE), controlling for sex, use of sleep medication, evening pain and total sleep time. Higher opioid dose predicted greater magnitude of discrepancy in SOL and SE. Opioid dose interacted with age to predict direction but not magnitude of discrepancy in SOL and SE. Specifically, higher opioid use was associated with better subjective (shorter SOL, higher SE) than objective reports of sleep among younger adults, and longer subjective than objectively measured SOL among older adults. Opioid dose did not predict magnitude or direction of WASO discrepancies. In FM, a higher opioid dose increases diary/actigraphy SOL and SE discrepancies, and direction of discrepancies may depend on age. We speculate that increased opioid use combined with age-related factors, such as slow wave sleep disruption, increased awakenings and/or cognitive decline, may impact perceived sleep.

PurposeTo determine obstructive sleep apnea (OSA) phenotypes using cluster analysis including variables of sleep perception and sleep quality and to further explore factors correlated with poor sleep quality in different clusters.MethodsThis retrospective study included patients with OSA undergoing polysomnography (PSG) between December 2020 and April 2022. Two-step cluster analysis was performed to detect distinct clusters using sleep perception variables including discrepancy in total sleep time (TST), sleep onset latency (SOL), and wakefulness after sleep onset (WASO); objective TST, SOL, and WASO; and sleep quality. One-way analysis of variance or chi-squared tests were used to compare clinical and PSG characteristics between clusters. Binary logistic regression analyses were used to explore factors correlated with poor sleep quality.ResultsA total of 1118 patients were included (81.6% men) with mean age ± SD 43.3 ± 13.1 years, Epworth sleepiness score, 5.7 ± 4.4, and insomnia severity index 3.0 ± 2.4. Five distinct OSA clusters were identified: cluster 1 (n = 254), underestimated TST; cluster 2 (n = 158), overestimated TST; cluster 3 (n = 169), overestimated SOL; cluster 4 (n = 155), normal sleep discrepancy and poor sleep quality; and cluster 5 (n = 382), normal sleep discrepancy and good sleep quality. Patients in cluster 2 were older, more commonly had hypertension, and had the lowest apnea–hypopnea index and oxygen desaturation index. Age and sleep efficiency were correlated with poor sleep quality in clusters 1, 2, and 5, and also AHI in cluster 2.ConclusionSubgroups of patients with OSA have different patterns of sleep perception and quality that may help us to further understand the characteristics of sleep perception in OSA and provide clues for personalized treatment.

Introduction Sleep metrics are essential for diagnosing insomnia and co-morbid insomnia with obstructive sleep apnea (COMISA). Single-night polysomnography (PSG) is insufficient for comprehensive evaluation, and actigraphy lacks the capability to measure apnea-hypopnea index (AHI). The optimal number of nights required for reliable assessment of insomnia and COMISA has not been established. This study aims to determine the minimum nights needed for accurate estimation of sleep metrics using the Belun Ring (BR). Methods Sixty-six participants with insomnia complaints (median age: 61 years; 61% female; 30% COMISA; median BMI: 23.6) were screened by a clinical psychologist and pulmonologist and underwent multiple-night BR testing. Insomnia was defined by an Insomnia Severity Index (ISI) ≥15 or a diagnosis per ICSD-3 criteria, and COMISA by insomnia criteria with PSG-AHI ≥15 events/h. Sleep metrics included total sleep time (TST), sleep efficiency (SE), REM sleep, wakefulness, sleep onset latency (SOL), wake after sleep onset (WASO), AHI4% and HRV time-domain metrics. Reference values were calculated as the average of all available nights. Concordance correlation coefficient (CCC) assessed agreement between 1-N night averages and reference values, with 1,000 bootstrapped simulations performed for each N-night scenario. Results Participants completed a median of 5 nights (IQR: 4–6; ≥100 minutes/night). Actual data showed key metrics reached a lower 95% CI CCC of ≥0.95 by the fourth night (e.g. AHI 4%, WASO, SOL, TST, SE, REM, RMSSD, SDNN, PNN50). Simulations confirmed that 4 nights were sufficient for good agreement (CCC ≥0.85) across most metrics, though SOL variability persisted beyond 6 nights. Sensitivity analysis, restricted to participants with ≥6 nights (N=27), yielded consistent results, with all metrics stabilising after 4 nights. Conclusion This study establishes that a minimum of four nights is required for reliable sleep metric assessment in insomnia and COMISA using the BR. This duration ensures accurate evaluation of HRV, OSA, and insomnia-related metrics. The BR offers significant advantages over PSG, actigraphy, and self-reports, delivering more precise diagnostics. The findings highlight how wearable-based sleep evaluations enhance the detection and management workflow for insomnia and underdiagnosed COMISA, especially in psychiatric settings. Support (if any)

Early To Bed, Early To Rise: LVAD Patients And Sleep Patterns