Change in Sleep Quality Associated With Adaptive Servoventilation for Central Sleep Apnea: Six-Month Follow-Up of the Multicenter Nationwide French "Etude de Cohorte Observationnelle Multicentrique Française de Patients Ayant un Syndrome d'Apnées du Sommeil Central ou Combiné Avec SAS Central Prédominant, Traités par Ventilation Auto-Asservie (FACIL-VAA)" Cohort

Abstract

Background: A large number of symptomatic individuals with central sleep apnea (CSA) in clinical practice have an indication for adaptive servoventilation (ASV) therapy.

Research question: What are the effects of ASV therapy on sleep quality and patient-reported outcome measures in patients with CSA across a range of devices and indications?

Study design and methods: This prospective multicenter observational cohort study was conducted in France and enrolled participants from June 2017 through February 2020. Adults with predominant CSA at diagnosis or OSA with central events not controlled with CPAP who had an indication for ASV were eligible. Participants attended clinic visits at baseline and after 1, 3, 6, and 12 months of follow-up. The primary end point was the change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to 6-month follow-up (evaluated using a Wilcoxon signed-rank test on paired data).

Results: We included 526 individuals (median age, 69 years; 88.2% male). The indication for ASV included CSA with cardiovascular or neurologic cause (38.4%), treatment-emergent CSA (36.1%), idiopathic CSA (14.1%), or drug-induced CSA (11.4%). At the 6-month follow-up, study participants were using ASV for a median of 6.1 h/night. The median change in the PSQI score from baseline to 6 months in the overall study population was -1 (interquartile range, -3 to 0; P < .001), with significant results across all indications for ASV except for drug-induced CSA, where the median change was similar to the overall results, but did not achieve statistical significance (-1 [interquartile range, -2 to 1]; P = .0866). Overall, 65% of participants showed a ≥ 1-point improvement in the PSQI.

Interpretation: In this study, individuals with a clinical indication for ASV therapy experienced improved sleep quality during real-world treatment, regardless of which ASV device was used.

Clinical trial registry: ClinicalTrials.gov; No.: NCT02835638; URL: www.

Clinicaltrials: gov.

Keywords: adaptive servoventilation; patient-reported outcomes; quality of life; sleep quality; sleep-disordered breathing; treatment.