Durability of treatment effects of the Sleep Position Trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial

• Published in: Sleep & breathing Vol. 22; no. 2; pp. 441 - 450
• Main Authors: de Ruiter, Maurits H. T., Benoist, Linda B. L., de Vries, Nico, de Lange, Jan
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.05.2018; Springer Nature B.V
• Subjects: Adult; Apnea; Clinical trials; Dentistry; Female; Follow-Up Studies; Humans; Internal Medicine; Male; Mandibular Advancement; Medicine; Medicine & Public Health; Middle Aged; Neurology; Otorhinolaryngology; Pediatrics; Pneumology/Respiratory System; Posture; Quality of Life; Sleep; Sleep apnea; Sleep Apnea, Obstructive - physiopathology; Sleep Apnea, Obstructive - therapy; Sleep Breathing Physiology and Disorders • Original; Sleep Breathing Physiology and Disorders • Original Article; Sleep disorders; Therapy; Treatment Outcome; Oral appliance therapy; Sleep position; Obstructive sleep apnea; Randomized controlled trial; Positional therapy
• ISSN: 1520-9512; 1522-1709
• DOI: 10.1007/s11325-017-1568-4

Purpose The Sleep Position Trainer (SPT) is a new option for treating patients with positional obstructive sleep apnea (POSA). This study investigated long-term efficacy, adherence, and quality of life during use of the SPT device compared with oral appliance therapy (OAT) in patients with POSA. Methods This prospective, multicenter trial randomized patients with mild to moderate POSA (apnea-hypopnea index [AHI] 5–30/h) to SPT or OAT. Polysomnography was performed at baseline and after 3 and 12 months’ follow-up. The primary endpoint was OSA severity; adherence, quality of life, and adverse events were also assessed. Results Ninety-nine patients were randomized and 58 completed the study (29 in each group). Median AHI in the SPT group decreased from 13.2/h at baseline to 7.1/h after 12 months ( P  < 0.001); corresponding values in the OAT group were 13.4/h and 5.0/h ( P  < 0.001), with no significant between-group difference ( P  = 1.000). Improvements throughout the study were maintained at 12 months. Long-term median adherence was also similar in the two treatment groups; the proportion of patients who used their device for ≥ 4 h for 5 days in a week was 100% in the SPT group and 97.0% in the OAT group ( P  = 0.598). Conclusions The efficacy of SPT therapy was maintained over 12 months and was comparable to that of OAT in patients with mild to moderate POSA. Adherence was relatively high, and similar in the two groups. Trial registration: www.clinicaltrials.gov (NCT02045576).