Journal of Clinical Sleep Medicine最新文献

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.

Study objectives: To evaluate the safety and efficacy of a novel bilateral hypoglossal nerve stimulation (HNS_BL) device for the treatment of obstructive sleep apnea.

Methods: Adult patients with moderate-to-severe obstructive sleep apnea who refused, failed, or did not tolerate positive airway pressure therapy underwent implantation and nightly use of HNS_BL. The coprimary endpoints at 12 months were (1) a minimum of 50% reduction in the 4% apnea-hypopnea index (AHI) from baseline with a final AHI of less than 20 events/h, and (2) a minimum of 25% reduction in the 4% oxygen desaturation index. Objective secondary endpoints included changes in mean AHI, oxygen desaturation index, and sleep time with blood oxygen saturation less than 90%. Self-reported secondary endpoints included changes in Epworth Sleepiness Scale, the short Functional Outcomes of Sleep Questionnaire score, the Symptoms of Nocturnal Obstruction and Related Events score, and bedpartner assessment of snoring.

Results: HNS_BL was implanted in 113 participants. Eleven serious adverse events occurred in 10 (8.7%) participants. The coprimary endpoints were completed by 89 (77.4%) participants. AHI and oxygen desaturation index responses were achieved in 63.5% (73/115, P = .002) and 71.3% (82/115, P < .001), respectively. Secondary endpoint analysis revealed significant changes in mean AHI (-18.3 ± 11.8 events/h, P < .001), oxygen desaturation index (-17.7 ± 14.6 events/h, P < .001), and sleep time with blood oxygen saturation less than 90% (6.9 ± 10.7%, P < .001). Significant changes were observed in all secondary endpoints (P < .001).

Conclusions: This pivotal clinical trial of HNS_BL demonstrated an acceptable safety profile with clinically significant improvements in obstructive sleep apnea severity and quality-of-life metrics. HNS_BL is a promising new treatment option for select patients with obstructive sleep apnea.

Clinical trial registration: Registry: ClinicalTrials.gov; Name: Dual-sided Hypoglossal NeRvE StimulAtion for the TreatMent of Obstructive Sleep Apnea (DREAM); URL: https://clinicaltrials.gov/study/NCT03868618; Identifier: NCT03868618.

Citation: Woodson BT, Kent DT, Huntley C, et al. Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial. J Clin Sleep Med. 2025;21(11):1883-1891.