Journal of Clinical Sleep Medicine最新文献

Study objectives: Evaluate nocturnal polysomnography sleep stage stability features in an adult, sample of clinical patients with hypersomnolence disorder (HD) against healthy sleeper controls (HSCs). Explore differences in sleep stage stability features across HD who displayed objective criteria for idiopathic hypersomnia (IH) (HD/IH+) and those who did not (HD/IH-).

Methods: Sixty unmedicated clinical patients with HD (average age = 28.6 ± 8.6 years; percentage female = 78.3%) and 29 HSCs underwent ad libitum nocturnal polysomnography and daytime Multiple Sleep Latency Tests. Sleep stage stability features included number of stage bouts, median stage bout duration, number of transitions between stages, and survival analysis of stage bouts. Regression and Cox proportional hazards models compared HD against HSC. Analysis of covariance, log-rank tests, and pairwise comparisons explored differences between HSC, HD/IH+ (n = 14), and HD/IH-. All analyses accounted for age, sex, body mass index, and depressive symptom severity.

Results: HD displayed longer non-rapid eye movement (NREM) stage 2 sleep bouts (P = .02) and increased survival of NREM stage 2 sleep (P < .0001) and rapid eye movement (REM) (P < .0001) bouts, relative to HSC, with fewer NREM stage 3 sleep bouts (P = .02) that were comparable in duration and survival. Many phenotypic similarities were observed between HD/IH+ and HD/IH-, though HD/IH+ displayed significantly increased NREM stage 2 sleep survival (P = .03), longer sleep duration (P = .004), and greater sleep continuity (P = .003).

Conclusions: Our findings demonstrate enhanced NREM stage 2 sleep and REM stability in adult clinical patients with unexplained hypersomnolence. Follow-up studies are necessary to determine the role of distinct sleep stage stability features as valid, reliable and specific signatures of unexplained hypersomnolence. These results may also be useful for future nosological frameworks that consider unexplained hypersomnolence along a continuum of severity that includes both HD and IH.

Citation: Cook JD, Rumble ME, Vascan AM, et al. Nocturnal sleep stage stability features in unexplained hypersomnolence. J Clin Sleep Med. 2025;21(11): 1911-1924.

Study objectives: We compared the performance of a comprehensive automated polysomnogram analysis algorithm-CAISR (Complete Artificial Intelligence Sleep Report)-to a multiexpert gold-standard panel, crowdsourced scorers, and experienced technicians for sleep staging and detecting arousals, respiratory events, and limb movements.

Methods: A benchmark dataset of 57 polysomnogram records (Inter-Scorer Reliability dataset) with 200 30-second epochs scored per American Academy of Sleep Medicine guidelines was used. Annotations were obtained from (1) the American Academy of Sleep Medicine multiexpert gold-standard panel, (2) American Academy of Sleep Medicine Inter-Scorer Reliability (ISR) platform users ("crowd," averaging 6,818 raters per epoch), (3) 3 experienced technicians, and (4) CAISR. Agreement was assessed via Cohen's kappa (κ) and percent agreement.

Results: Across tasks, CAISR achieved performance comparable to that of experienced technicians but did not match consensus-level agreement between the multiexpert gold standard and the crowd. For sleep staging, CAISR's agreement with multiexpert gold standard was 82.1% (κ = 0.70), comparable to experienced technicians but below the crowd (κ = 0.88). Arousal detection showed 87.81% agreement (κ = 0.45), respiratory event detection 83.18% agreement (κ = 0.34), and limb movement detection 94.89% agreement (κ = 0.11), each aligning with performance equivalent to experienced technicians but trailing crowd agreement (κ = 0.83, 0.78, and 0.86 for detection of arousal, respiratory events, and limb movements, respectively).

Conclusions: CAISR achieves experienced technician-level accuracy for polysomnogram scoring tasks but does not surpass the consensus-level agreement of a multiexpert gold standard or the crowd. These findings highlight the potential of automated scoring to match experienced technician-level performance while emphasizing the value of multirater consensus.

Citation: Tripathi A, Nasiri S, Ganglberger W, et al. Automated analysis of the American Academy of Sleep Medicine Inter-Scorer Reliability gold-standard polysomnogram dataset. J Clin Sleep Med. 2025;21(11):1821-1829.

Study objectives: Sleep apnea occurs more often in patients with primary aldosteronism (PA), whereas unsuppressed plasma renin activity (PRA) after treatment is associated with a lower risk of cardiovascular events. However, the relationship between PA and severe sleep apnea remains unclear, and it is not known whether PRA following treatment is associated with an apnea condition in affected patients.

Methods: Cross-sectional relationships between PA (n = 176 affected patients) and severe sleep apnea, classified by respiratory event index obtained with use of an Apnomonitor, were examined, with the results compared to those of patients with essential hypertension (n = 418). Additionally, the correlation between PRA at follow-up and change in respiratory event index findings obtained at baseline and follow-up examinations was analyzed in 45 patients with PA, stratified based on treatment status.

Results: PA was found to be significantly associated with severe sleep apnea compared to essential hypertension, even after adjustment for other clinical risk factors (odds ratio = 2.08, 95% confidence interval = 1.09-3.95, P = .025). Furthermore, posttreatment PRA showed a significantly negative correlation with change in respiratory event index from before to after treatment (r = -0.550, P = .004).

Conclusions: Compared to patients with essential hypertension, those with PA had a higher prevalence of severe sleep apnea. Furthermore, a significantly negative correlation of posttreatment PRA with a change in respiratory event index from before to after treatment was noted.

Citation: Kidawara Y, Kadoya M, Igeta M, et al. Association of primary aldosteronism with severe sleep apnea and correlation between posttreatment renin activity and amount of change in respiratory event index during sleep. J Clin Sleep Med. 2025;21(11):1935-1942.

Study objectives: Previous studies have suggested that obstructive sleep apnea (OSA) may be associated with aortic dilatation. We aimed to further characterize the association between OSA severity with thoracic aortic diameter.

Methods: We evaluated 1,470 patients attending an Australian clinic during 2014-2023 and who underwent transthoracic echocardiogram followed by polysomnographic study in the following 6 months (43.7% female, median age 65 years, median body mass index 29.6 kg/m²). Aortic root and ascending aortic diameters were compared among patients based on OSA severity, defined by apnea-hypopnea index.

Results: OSA was observed in 90% of patients. Both aortic root and ascending aorta diameters were associated with increasing OSA severity (P < .01). These associations remained significant when indexed for height, but not body surface area. Multivariate analysis considering age, weight, hypertension status, atrial fibrillation, and smoking history suggested an independent role of OSA on aortic dimensions in females but not in males. However, a case-control sensitivity analysis did not demonstrate a significant difference in aortic diameter between no/mild OSA compared to moderate/severe OSA.

Conclusions: This is the largest study examining the association of OSA and thoracic aortic dimensions in a clinical sample. It found a significant increase in both aortic root and ascending aorta diameters with increasing OSA severity, although this may be explained by shared risk factors such as age, body mass index, hypertension, and atrial fibrillation. A minor independent association between aortic dimensions and OSA severity was observed in females but not males. Further research is warranted to explore the relationship between OSA and aortopathy.

Citation: Cistulli DC, Tong BK, Currie PJ, et al. Association between obstructive sleep apnea and thoracic aortic diameter: a cross-sectional study in a clinical sample. J Clin Sleep Med. 2025;21(11):1847-1855.

Narcolepsy is a chronic sleep disorder that causes overwhelming daytime sleepiness. In an effort to continue addressing gaps and variations in care in this patient population, the American Academy of Sleep Medicine Quality Measures Task Force performed quality measure maintenance on the Quality Measures for the Care of Patients with Narcolepsy (originally developed in 2015). The Quality Measures Task Force reviewed the current medical literature, including updated clinical practice guidelines and systematic literature reviews, existing narcolepsy quality measures, and performance data highlighting remaining gaps or variations in care.

Citation: Lloyd RM, Crawford T, Donald R, et al. Quality measure for care of patients with narcolepsy: 2025 update after measure maintenance. J Clin Sleep Med. 2025;21(11):1943-1951.

Study objectives: The majority of patients with Prader-Willi syndrome experience excessive daytime sleepiness (EDS). This study evaluated the effects of pitolisant, a histamine 3 (H₃)-receptor antagonist/inverse agonist that promotes wakefulness, in patients with Prader-Willi syndrome and EDS.

Methods: In this phase 2, randomized, double-blind, placebo-controlled, proof-of-concept study, patients ages 6-65 years with a confirmed diagnosis of Prader-Willi syndrome with EDS were randomized 1:1:1 to receive lower-dose pitolisant (children/adolescents/adults, 8.9/13.35/17.8 mg), higher-dose pitolisant (children/adolescents/adults, 17.8/26.7/35.6 mg), or matching placebo for 11 weeks (3-week titration/8-week maintenance). The primary endpoint was change from baseline to week 11 in Epworth Sleepiness Scale for Children and Adolescents (parent/caregiver version) score. Other measures included the Caregiver Global Impression of Severity for EDS, Aberrant Behavior Checklist-Community, second edition, and Hyperphagia Questionnaire for Clinical Trials.

Results: Of 65 patients randomized and treated, 59 (90.8%) completed the double-blind phase. Least-squares (LS) mean improvement from baseline to week 11 in Epworth Sleepiness Scale for Children and Adolescents score was greater for higher-dose pitolisant (-5.0) vs placebo (-3.9; LS mean [standard error] difference, -1.1 [1.52]), but not for lower-dose pitolisant (-3.5) vs placebo (LS mean [standard error] difference, 0.5 [1.6]). The largest effect of pitolisant was seen in children (ages 6 to < 12 years; LS mean [standard error] difference for higher-dose pitolisant vs placebo, -3.5 [1.90]). Improvements were observed across other measures, especially in the higher-dose pitolisant group, including LS mean (standard error) change of -5.5 (1.2) on the irritability domain of the Aberrant Behavior Checklist-Community, second edition, and -3.1 (1.0) on the Hyperphagia Questionnaire for Clinical Trials. The most common adverse events in pitolisant-treated patients (doses pooled) were anxiety, irritability, and headache (11.9% each), consistent with the known safety profile of pitolisant.

Conclusions: Results of this proof-of-concept study support further evaluation of pitolisant in patients with Prader-Willi syndrome and EDS.

Clinical trial registration: Registry: ClinicalTrials.gov; Name: A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension; URL: https://clinicaltrials.gov/study/NCT04257929; Identifier: NCT04257929.

Citation: Revana A, Bhattacharjee R, Miller JL, et al. A proof-of-concept study of pitolisant for excessive daytime sleepiness in patients with Prader-Willi syndrome. J Clin Sleep Med. 2025;21(11):1893-1902.

Study objectives: We sought to determine the role of sleep-disordered breathing, insomnia symptoms, and sleep quality in the daytime function and quality of life of veterans with spinal cord injury.

Methods: This cross-sectional cohort study took place in a Veterans Administration medical center in the midwestern United States. Thirty-eight male veterans with spinal cord injury (22 cervical, 16 thoracic; mean [standard deviation] age = 62.9 [9.5] years) completed baseline assessments within a larger clinical trial. Measures assessed sleep apnea severity (apnea-hypopnea index), insomnia symptoms (Insomnia Severity Index), self-reported sleep quality (Pittsburg Sleep Quality Index), daytime sleepiness (Epworth Sleepiness Scale), fatigue (Flinders Fatigue Scale), depression (Patient Health Questionnaire-9 item, excluding sleep item), functioning (Spinal Cord Independence Measure), and quality of life (World Health Organization Quality of Life). Bivariate correlations (alpha P < .05) were used to assess relationships between sleep (apnea-hypopnea index, Insomnia Severity Index, Pittsburg Sleep Quality Index, Epworth Sleepiness Scale) and function (Flinders Fatigue Scale, Patient Health Questionnaire-9 item, Spinal Cord Independence Measure, World Health Organization Quality of Life).

Results: Mean apnea-hypopnea index was 29.9 (26.6) events/h, mean Insomnia Severity Index was 9.4 (6.2), mean Pittsburg Sleep Quality Index was 9.0 (4.6), and mean Epworth Sleepiness Scale was 7.0 (5.2). There were no significant relationships between apnea-hypopnea index and function measures. Significant relationships emerged between worse Insomnia Severity Index and worse Patient Health Questionnaire-9, some World Health Organization Quality of Life subscales, and Spinal Cord Independence Measure as well as between worse Pittsburg Sleep Quality Index and worse Flinders Fatigue Scale, Patient Health Questionnaire-9 item, and some World Health Organization Quality of Life subscales (P < .05).

Conclusions: Among veterans with spinal cord injury, insomnia symptom severity and poor sleep quality were associated with worse functioning, whereas sleep-disordered breathing severity was not. Insomnia and poor sleep quality represent modifiable contributors to poor daytime function. Research evaluating the impact of evidence-based insomnia treatments among individuals living with spinal cord injury is warranted.

Clinical trial registration: Registry: ClinicalTrials.gov; Name: Treatment of Sleep-disordered Breathing in Patients With SCI; URL: https://www.clinicaltrials.gov/study/NCT02830074; Identifier: NCT02830074.

Citation: Badr AN, Zeineddine S, Salloum A, et al. Sleep and daytime function in people with spinal cord injury. J Clin Sleep Med. 2025;21(11):1903-1909.

Study objectives: Long COVID presents with symptoms that persist for weeks or months postinfection, with sleep disturbances that significantly affect quality of life. The diverse approaches to managing sleep disturbances highlight the need for comparing treatment effectiveness to improve patient outcomes. This study systematically reviews and conducts a meta-analysis of randomized controlled trials to assess the effectiveness of current interventions for sleep disturbances in patients with long COVID and explores the underlying mechanisms and promising treatments.

Methods: Relevant studies were identified through a comprehensive literature search across Embase, Web of Science, PubMed, Cochrane Library, China National Knowledge Infrastructure, and Wanfang Data databases. The included studies focused on interventions aimed at managing patients with long COVID with sleep disturbances. Data extraction and analysis were performed, followed by a meta-analysis of comparable studies. The quality of evidence was assessed using the Cochrane Risk of Bias Tool (RoB 2.0) and the Grading of Recommendations, Assessment, Development, and Evaluation system.

Results: Out of 3,352 retrieved studies, 14 were included in the systematic review and 2 in the meta-analysis. Interventions were categorized as pharmacological and nonpharmacological. Whereas most studies indicated improved sleep quality measured by standardized scales, some did not demonstrate significant benefits. The quality of evidence varied from low to moderate.

Conclusions: The results suggest that sleep disturbances in patients with long COVID result from a complex interplay of physiological, psychological, and neurological factors. Both pharmacological and nonpharmacological interventions show potential in managing these disturbances, with nonpharmacological approaches showing particular promise. To establish more robust evidence, more high-quality, large-scale randomized controlled trials are necessary in future research.

Citation: Goh DY, Lam WC, Zhong LLD. Effect of interventions for the management of sleep disturbances in patients with long COVID: a systematic review and meta-analysis of randomized controlled trials. J Clin Sleep Med. 2025;21(11):1993-2005.