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01-09-2020 | Sleep Apnea | Sleep Breathing Physiology and Disorders • Original Article

Randomized crossover study of tongue-retaining device and positive airway pressure for obstructive sleep apnea

Authors: Wish Banhiran, Anuch Durongphan, Phawin Keskool, Cheerasook Chongkolwatana, Choakchai Metheetrairut

Published in: Sleep and Breathing | Issue 3/2020

Abstract

Purpose

To compare the efficacy of tongue-retaining device (TRD) versus continuous positive airway pressure (CPAP) for treatment of obstructive sleep apnea (OSA).

Study design

Randomized crossover study.

Subjects and methods

Thirty-six patients with a mean age of 52.7 ± 10.6 years were enrolled. Inclusion criteria were age ≥ 18 years, apnea-hypopnea index (AHI) ≥ 5 events/h, and minimum oxygen saturation (SO₂) ≥ 70% from polysomnography (PSG). Exclusion criteria were severe periodontal disease, unstable cardiopulmonary or neurological diseases, and/or total sleep time < 2 h. A 1-week wash-in period was followed by questionnaires and randomization into two groups: TRD/CPAP and CPAP/TRD (18 patients each). After 3 weeks of intervention, questionnaires were re-administered and WatchPAT was performed. After a 1-week wash-out period, patients were switched to the other treatment. Primary outcome was AHI. Secondary outcomes were SO₂, Functional Outcomes of Sleep Questionnaire (FOSQ), and Epworth Sleepiness Scale (ESS) scores, treatment side effects, and adherence.

Results

Nine patients withdrew, so 27 patients were included in the final analysis. Mean AHI decreased from 38.7 ± 24.0 to 2.5 ± 0.5 and 12.7 ± 2.6 events/h for CPAP and TRD, respectively (95% confidence interval of mean differences 4.65–15.62; p < 0.001). There was no significant difference in ESS and FOSQ scores between treatments. Common adverse effects were drooling, tongue numbness, and pain for TRD; and nasal blockage, mask compression, and difficult portability for CPAP.

Conclusions

CPAP was superior to TRD for resolving PSG parameters; however, both similarly improved QOL and daytime sleepiness. TRD might be considered a short-term alternative treatment for OSA.

Trial registration

NCT02788487

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Title: Randomized crossover study of tongue-retaining device and positive airway pressure for obstructive sleep apnea
Authors: Wish Banhiran
Anuch Durongphan
Phawin Keskool
Cheerasook Chongkolwatana
Choakchai Metheetrairut
Publication date: 01-09-2020
Publisher: Springer International Publishing
Keywords: Sleep Apnea
Polysomnography
Published in: Sleep and Breathing / Issue 3/2020
Print ISSN: 1520-9512
Electronic ISSN: 1522-1709
DOI: https://doi.org/10.1007/s11325-019-01942-z

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Randomized crossover study of tongue-retaining device and positive airway pressure for obstructive sleep apnea

Abstract

Purpose

Study design

Subjects and methods

Results

Conclusions

Trial registration

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Abstract

Purpose

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Subjects and methods

Results

Conclusions

Trial registration

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