Ann Am Thorac Soc. 2023 Nov 28. doi: 10.1513/AnnalsATS.202309-753OC. Online ahead of print.
ABSTRACT
RATIONALE: Around 20-35% of obstructive sleep apnoea (OSA) patients show supine-isolated OSA, where supine sleep avoidance could be an effective therapy. However, traditional supine discomfort-based methods show poor tolerance and compliance to treatment, so cannot be recommended. Supine-alarm devices show promise, but evidence to support favourable adherence to treatment and effectiveness at reducing excessive daytime sleepiness compared to continuous positive airway pressure (CPAP) remains limited.
OBJECTIVES: To establish if alarm-based supine-avoidance treatment in supine-isolated OSA patients is non-inferior to CPAP in reducing daytime sleepiness.
METHODS: Following baseline questionnaires and in-home supine-time and polysomnography assessments, patients with supine-isolated OSA and Epworth sleepiness scale (ESS) score ≥8 were randomised to ≥6 weeks of supine-avoidance or CPAP treatment, followed by cross-over to the remaining treatment with repeat assessments. Non-inferiority was assessed from change in ESS with supine-avoidance compared to CPAP using a pre-specified non-inferiority margin of 1.5. Average nightly treatment use over all nights, and treatment efficacy and effectiveness at reducing respiratory disturbances were also compared between treatments.
RESULTS: The reduction in sleepiness score with supine-avoidance (mean [95%CI] -1.9 [-2.8 to -1.0]) was non-inferior to CPAP (-2.4 [-3.3 to -1.4], supine-avoidance-CPAP difference -0.4 [-1.3 to 0.6]) and the lower confidence limit did not cross the non-inferiority margin of 1.5, p=0.021. Average treatment usage was higher with supine-avoidance compared to CPAP (mean ± SD 5.7 ± 2.4 versus 3.9 ± 2.7 h/night, p<0.001).
CONCLUSIONS: In patients with supine-isolated OSA, vibro-tactile supine alarm device therapy is non-inferior to CPAP for reducing sleepiness and shows superior treatment adherence.
PMID:38015501 | DOI:10.1513/AnnalsATS.202309-753OC
