Journal of Clinical Sleep Medicine最新文献

Study objectives: Mouth leak during continuous positive airway pressure (CPAP) therapy is a common barrier to tolerability and adherence and is often managed with chinstraps. We investigated whether V̇-Com, a device that reduces inspiratory pressure by adding noncompensated resistance into the CPAP circuit, could lower the chinstrap usage rate during in-laboratory titration. Additionally, we tested the effect of V̇-Com on study abortion rate due to CPAP intolerance.

Methods: We conducted a retrospective study of in-laboratory CPAP titrations performed at a multisite sleep center. Mouth leak was identified based on ventilator-reported leak (> 30 L/min), visual observation of mouth opening, or characteristic alterations in the flow signal. V̇-Com was added as a first-line intervention when mouth leak was detected. If V̇-Com proved ineffective, it was removed, and a chinstrap was utilized. Similarly, V̇-Com was used in the attempt to salvage studies that were otherwise going to be aborted due to positive airway pressure intolerance.

Results: Among 1,632 titrations, 190 patients (12%) experienced mouth leak and 46 individuals requested to abort their titration due to positive airway pressure intolerance (3%). V̇-Com reduced the chinstrap usage rate by 68% and the study abortion rate by 91%. In sensitivity analysis modeling hypothetical placebo response rates, the number needed to treat to avoid chinstrap use in 1 additional participant remained as low as 5, even under conservative assumptions.

Conclusions: V̇-Com was associated with reduced chinstrap use and fewer aborted studies during CPAP titration. This suggests that V̇-Com may serve as a useful tool to improve pressure tolerance and leak management.

Citation: Messineo L, Keasling C, Hughes B, et al. The impact of V̇-Com on chinstrap usage and study completion rates during CPAP titration. J Clin Sleep Med. 2025;21(12):2121-2127.

Study objectives: While not all sleep laboratories distinguish between obstructive and central hypopneas, recent research suggests that patients may receive an incorrect primary diagnosis without this effort. The remedē System Pivotal Trial studied transvenous phrenic nerve stimulation in patients with moderate-to-severe central sleep apnea. Entry criteria required apnea-hypopnea index (AHI) ≥ 20 events/h with central apnea index greater than obstructive apnea index and obstructive apneas < 20% of AHI but did not classify hypopneas. This analysis re-examined sleep studies from the trial to assess hypopnea classification impact on candidacy and treatment outcomes.

Methods: Hypopneas were classified as central vs obstructive by a sleep core laboratory following a modified version of American Academy of Sleep Medicine recommended criteria. AHI composition was assessed pre/post treatment.

Results: At baseline, 91% (138/151) of patients had ≥ 50% of events classified as central accounting for hypopnea classification. If all hypopneas were assumed obstructive, only 63% (95/151) would have had ≥ 50% central events. The likelihood of achieving ≥ 50% AHI reduction increased with the percentage of baseline events that were central: responder rates were 37.5% for patients with < 50% central events, incrementally increasing to 76.5% for those with ≥ 90% central events. At 6 months, residual AHI predominantly consisted of obstructive hypopneas. Central events decreased by 89% with treatment (baseline median 32 events/h). Obstructive apneas and hypopneas increased by 2 and 3 events/h, respectively.

Conclusions: Distinguishing central from obstructive hypopneas is required to accurately determine the proportion of central and obstructive breathing events, and is crucial for appropriate therapy selection and managing patient expectations about treatment outcomes.

Clinical trial registration: Registry: ClinicalTrials.gov; Name: Respicardia, Inc. Pivotal Trial of the remede System; URL: https://www.clinicaltrials.gov/study/NCT01816776, Identifier: NCT01816776.

Citation: Dupuy-McCauley K, Schwartz AR, Javaheri S, Germany R, McKane S, Morgenthaler TI. Classifying hypopneas as obstructive or central can enhance transvenous phrenic nerve stimulation therapy patient selection and outcomes. J Clin Sleep Med. 2025;21(12):2113-2120.

Study objectives: We assessed the use of mouth tape in patients with mouth breathing during continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea, focusing on CPAP adherence. Additional outcomes included daytime sleepiness (Epworth Sleepiness Scale), snoring (visual analog scale), night awakenings, mouth/throat dryness, leakage, and adverse effects.

Methods: This randomized crossover study compared CPAP adherence with and without silicone hypoallergenic mouth tape. Participants used each intervention for 30 days, separated by a 1-week washout period. After each period, CPAP data (adherence, apnea-hypopnea index, leakage) and questionnaires were retrieved.

Results: Sixty-two patients with obstructive sleep apnea (36 males; apnea-hypopnea index [mean ± standard deviation], 45.8 ± 22.2 events/h; age, 57.7 ± 17.6 years; body mass index, 27.9 ± 7.1 kg/m²) were randomly assigned. Participants using mouth tape, compared to those without, showed better CPAP adherence: Average use increased by 51.8 minutes per day (95% confidence interval, 33.1-70.4) and by 41.4 minutes per used day (95% confidence interval, 27.9-55.0). Frequency of use increased by 14.2% (95% confidence interval, 9.3-19.0), with 17.6% more days reaching ≥ 4 hours/night (95% confidence interval, 12.7-22.6). Good adherence increased with an odds ratio of 4.5. Mouth tape statistically improved Epworth Sleepiness Scale score, snoring visual analog scale, mouth/throat dryness, and night awakenings. Adverse effects were reported.

Conclusions: Using mouth tape in patients with mouth breathing during CPAP improved CPAP adherence in both duration and frequency. Unfavorable symptoms related to obstructive sleep apnea or CPAP were alleviated, leading to better sleep quality.

Citation: Meksukree A, Pitipanyakul S, Laohavinij W, et al. The role of mouth tape for CPAP use in patients with mouth breathing and OSA. J Clin Sleep Med. 2025;21(12):2063-2071.

Study objectives: Restless legs syndrome (RLS) has long been associated with iron deficiency. Current clinical guidelines recommend intravenous (IV) iron therapy for patients with serum ferritin levels ≤ 100 µg/L, but the effectiveness and safety of IV iron in patients with ferritin levels between 100 and 300 µg/L have not been well established. The aim of this study is to assess the efficacy and safety of IV iron in patients with RLS with serum ferritin levels both below and above the 100 µg/L threshold, hypothesizing no significant differences in therapeutic response between these groups.

Methods: We conducted a longitudinal retrospective analysis of 58 patients with RLS treated with 1,000 mg of ferric carboxymaltose, with baseline serum ferritin concentrations < 300 µg/L. Patients were divided into 2 groups: group A (serum ferritin < 100 µg/L) and group B (serum ferritin 100-300 µg/L). We compared changes in symptom severity (International Restless Legs Syndrome Severity Scale), substantia nigra iron deposits (substantia nigra echogenicity index), and systemic iron parameters.

Results: Both groups showed similar improvements in International Restless Legs Syndrome Severity Scale scores and substantia nigra echogenicity index. Serum ferritin increased significantly in group B posttreatment, while no major differences were observed in transferrin saturation or serum transferrin levels between the 2 groups. Regarding risk of iron overload, only 2 patients (group B) showed a transferrin saturation > 45%. No harm resulted to either patient, with no hepatic dysfunction observed.

Conclusions: IV iron therapy is effective in patients with RLS without hepatic iron overload with serum ferritin levels ranging from 100-300 µg/L. These findings challenge current guidelines and suggest that IV iron could be considered for a broader range of patients with RLS.

Citation: Garcia-Malo C, Garcia-Borreguero D, Silber MH. Efficacy and safety of intravenous iron in patients with restless legs syndrome with normal serum ferritin levels: a stratified subanalysis. J Clin Sleep Med. 2025;21(12):2023-2029.

Study objectives: Sleep misperception is well-documented in insomnia but remains understudied in central disorders of hypersomnolence (CDH). This study aimed to examine (1) total sleep time (TST) misperception in CDH and healthy controls, (2) the prevalence of accurate estimators, underestimators, and overestimators, and (3) the relationship between misperception and polysomnography fragmentation variables.

Methods: We included 420 adults with CDH (38 narcolepsy type 1, 52 narcolepsy type 2, 192 idiopathic hypersomnia, 138 nonspecified hypersomnia) and 86 healthy controls tested in Montreal, Quebec, Canada. A replication cohort from a National Reference Center in France (n = 182; 79 narcolepsy type 1, 13 narcolepsy type 2, 35 idiopathic hypersomnia, 55 nonspecified hypersomnia) was also analyzed. Participants underwent full-night polysomnographies, Multiple Sleep Latency Tests, and clinical interviews. TST misperception was defined as the ratio between self-reported to objective TST. Group comparisons were performed using analyses of covariance adjusting for age and sex, and chi-square tests. Partial correlations were conducted to explore relationships between sleep fragmentation and TST misperception.

Results: In the Canadian cohort, all CDH subgroups underestimated their TST relative to controls (P < .001). The highest underestimation rates occurred in narcolepsy type 1 (44.7%) and idiopathic hypersomnia (26.6%), while the lowest was observed in healthy controls (11.6%). The French cohort confirmed the absence of significant differences in TST misperception between CDH subgroups. No correlations were found between polysomnography fragmentation variables and TST misperception.

Conclusions: Underestimation of nocturnal TST is common in adults with CDH and may complicate clinical assessment. These findings underscore the importance of integrating objective sleep measures when evaluating patients with hypersomnolence.

Citation: Mombelli S, Deshaies-Rugama A-S, Blais H, et al. Underestimation of nocturnal sleep duration in central disorders of hypersomnolence: an underrecognized feature? J Clin Sleep Med. 2025;21(12):2101-2112.

Study objectives: Obstructive sleep apnea (OSA) is a common condition that contributes to atrial fibrillation occurrence, but the evidence on the day-night pattern of paroxysmal atrial fibrillation (PAF) is still scanty. The aim of this study was to evaluate whether OSA is associated with a higher occurrence of PAF, especially PAF events during the nighttime, and determine the frequency and potential underdiagnoses of OSA in patients with PAF.

Methods: We recruited consecutive patients who had undergone a recent 24-hour Holter monitoring and showed at least 1 episode of PAF. All patients were invited to undergo a clinical evaluation. To assess OSA status, we conducted validated portable sleep monitoring. OSA was defined by an apnea-hypopnea index of ≥ 15 events/h.

Results: We studied 102 patients (mean age: 64 ± 9 years, 56% male). Sixty patients (57%) had OSA (none with a previous diagnosis). A total of 339 episodes of PAF (a third of them occurring at night) were available for analysis. We observed a significant association between OSA and nighttime PAF episodes: patients with OSA had a higher chance of nighttime episodes than those without OSA (odds ratio = 1.78, 95% confidence interval = 1.12-2.83; P = .014). Interestingly, the distribution of PAF episodes over 24 hours showed that patients with OSA had more atrial fibrillation episodes between 10 pm and 4 am than patients without OSA (OSA: median = 10 [interquartile range = 7.5-11] vs No OSA: median = 2 [interquartile range = 3-5.5]; P = .037), suggesting an abnormal day-night pattern of the PAF occurrence.

Conclusions: OSA is common, underdiagnosed, and in patients with OSA, associated with a higher nighttime occurrence of PAF episodes compared with patients without OSA.

Citation: Rocha CMG, de Medeiros HD, Brigido ARD, et al. Obstructive sleep apnea and the day-night pattern of paroxysmal atrial fibrillation burden. J Clin Sleep Med. 2025;21(12):2073-2079.