Abstract Introduction Improving outcomes for patients with mild-to-moderate sleep disordered breathing (SDB) remains a clinical challenge. A key limitation of the existing literature is failure to consider the contribution of insufficient sleep. Both SDB and insufficient sleep contribute to daytime sleepiness, although treatment typically focuses only on positive airway pressure (PAP) therapy use. This randomized trial (NCT04279834) evaluated whether a 4-week behavioral sleep time extension (STE) intervention was superior to PAP + a 4-week behavioral adherence program (PAP+BA) in reducing daytime sleepiness and fatigue symptoms among patients with mild to moderate SDB and insufficient sleep. Methods Participants were enrolled from 2 accredited sleep disorders centers in Detroit, MI. 129 individuals with an AHI of 5.0-29.9, a diary total sleep time 7 hours at least 4 nights/week, and evidence of baseline sleepiness were randomized to receive either STE or PAP+BA. The main outcomes were (1) changes in Epworth Sleepiness Scale (ESS) and (2) Fatigue Severity Scale (FSS) total scores at 3-month follow-up (main outcome time point). Mixed effects models were used to test the time (baseline, post-treatment, 3-month follow-up) x treatment group (STE, PAP+BA) interactions. Follow-up analyses were conducted within each treatment group. Results At baseline, 129 randomized participants (74 women; mean age = 51.7±12.5 yrs, AHI= 15.5±7.5), had mean (SD) ESS =10.7 (4.1), and mean (SD) FSS = 36.0 (11.6). There were no time x group interactions (p’s.05). For PAP+BA, ESS decreased from baseline to 3-month follow up (mean (SD) change = -2.9 (4.6); p.001), and FSS decreased from baseline to 3-month follow-up (mean (SD) change = -3.1 (10.2); p=.014). For STE, ESS decreased from baseline to 3-month follow up (mean (SD) change = -2.4 (5.4); p.001), and FSS decreased significantly from baseline to 3-month follow-up (mean (SD) change = -3.4 (9.8); p=.014). Conclusion Both STE and PAP+BA led to reductions in sleepiness and fatigue, with no evidence of superiority of one treatment over the other. Clinicians should consider each of these options when determining how best to reduce daytime sleepiness among patients with mild-to-moderate SDB and insufficient sleep. Support (if any) Support: NIH/NHLBI R01HL146059, K24HL143055, and K23HL157754
Badr et al. (Fri,) studied this question.