A randomized, controlled trial of positional therapy versus oral appliance therapy for position-dependent sleep apnea

Sleep Med. 2017 Jun;34:109-117. doi: 10.1016/j.sleep.2017.01.024. Epub 2017 Mar 27.

Abstract

Objective: To compare the effectiveness of positional therapy (PT) with the sleep position trainer (SPT) to oral appliance therapy (OAT) in patients with mild-to-moderate positional obstructive sleep apnea (POSA).

Methods: Multicenter, prospective, randomized, controlled trial. Patients with mild-to-moderate POSA (apnea-hypopnea index (AHI) ≥5 ≤ 30/hour sleep) were randomized for PT or OAT. Polysomnography was repeated after 3 months. Efficacy, adherence, mean disease alleviation (MDA), quality of life, dropouts and adverse events were evaluated.

Results: A total of 177 patients were screened for the study; 99 underwent randomization and 81 completed the study. Intention-to-treat (ITT) analysis of median [IQR] AHI showed a reduction in the PT group from 13.0 [9.7-18.5] to 7.0 [3.8-12.8], p < 0.001 and in the OAT group from 11.7 [9.0-16.2] to 9.1 [4.9-11.7], p < 0.001. Mean adherence (≥4 h/night, ≥5 days/week) was 89.3 ± 22.4% for SPT versus 81.3 ± 30.0% in OAT patients, p = 0.208.

Conclusions: Oral appliance therapy and positional therapy were equally effective in reducing the median AHI in patients with mild-to-moderate POSA. The results of this study have important implications for future OSA treatment guidelines and daily clinical practice. CLINICALTRIALS.

Gov number: NCT02045576.

Keywords: Obstructive sleep apnea; Oral appliances; Positional obstructive sleep apnea; Positional therapy; Randomized, controlled trial.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Female
  • Humans
  • Male
  • Mandibular Advancement* / instrumentation
  • Middle Aged
  • Mouth
  • Orthodontic Appliances, Removable*
  • Patient Compliance
  • Patient Dropouts
  • Patient Positioning*
  • Polysomnography
  • Quality of Life
  • Respiration
  • Sleep Apnea Syndromes / therapy*
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT02045576