Abstract
PurposeThe 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.MethodsThis 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.ResultsNinety-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).ConclusionsThe 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).
Highlights
Obstructive sleep apnea (OSA) is the most common sleeprelated breathing disorder
This study investigated long-term efficacy, adherence, and quality of life during use of the Sleep Position Trainer (SPT) device compared with oral appliance therapy (OAT) in patients with positional obstructive sleep apnea (POSA)
A total of 177 patients with mild to moderate POSA were screened for eligibility (70.7% male, age 48.3 ± 10.1 years; body mass index (BMI) 27.6 ± 3.8 kg/m2)
Summary
Obstructive sleep apnea (OSA) is the most common sleeprelated breathing disorder. With an overall prevalence of 9– 38% in the general adult population, OSA is more common in men and increases with age [1]. Recent data from Switzerland showed that OSA was more prevalent than previously reported. The proportion of men and women with an apneahypopnea index (AHI) of > 5/h on polysomnography (PSG) was 84 and 61%, respectively [2]. An AHI of ≥ 5/h is required for a diagnosis of OSA, with disease severity rated as mild if the AHI is 5–15/h, moderate if the AHI is 15–30/h, and severe if the AHI is > 30/h [3]. OSA is characterized by recurrent (partial) obstruction of the upper airway, accompanied by oxygen desaturation, sleep
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