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Open Access 15.09.2017 | Sleep Breathing Physiology and Disorders • Original Article

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

verfasst von: Maurits H. T. de Ruiter, Linda B. L. Benoist, Nico de Vries, Jan de Lange

Erschienen in: Sleep and Breathing | Ausgabe 2/2018

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Abstract

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).

Nur mit Berechtigung zugänglich

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Titel: 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
verfasst von: Maurits H. T. de Ruiter
Linda B. L. Benoist
Nico de Vries
Jan de Lange
Publikationsdatum: 15.09.2017
Verlag: Springer International Publishing
Erschienen in: Sleep and Breathing / Ausgabe 2/2018
Print ISSN: 1520-9512
Elektronische ISSN: 1522-1709
DOI: https://doi.org/10.1007/s11325-017-1568-4

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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

Abstract

Purpose

Methods

Results

Conclusions

Trial registration:

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Abstract

Purpose

Methods

Results

Conclusions

Trial registration:

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