Control of Tongue Position in Patients with Obstructive Sleep Apnea: Concept and Protocol for a Randomized Controlled Crossover Trial

Tatsuya Fukuda, Yuuya Kohzuka, Fernanda R. Almeida, Takehiko Iijima, Rikuo Masuda and Satoru Tsuiki ()
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Tatsuya Fukuda: Research Department, Institute of Neuropsychiatry, 91, Bentencho, Shinjuku-ku, Tokyo 162-0851, Japan
Yuuya Kohzuka: Department of Perioperative Medicine, Division of Anesthesiology, Showa University School of Dentistry, 2-1-1 Kitasenzoku, Ota-ku, Tokyo 145-8515, Japan
Fernanda R. Almeida: Department of Oral Health Sciences, Faculty of Dentistry, The University of British Columbia, 2199 Wesbrook Mall, Vancouver, BC V6T 1Z3, Canada
Takehiko Iijima: Department of Perioperative Medicine, Division of Anesthesiology, Showa University School of Dentistry, 2-1-1 Kitasenzoku, Ota-ku, Tokyo 145-8515, Japan
Rikuo Masuda: Department of Perioperative Medicine, Division of Anesthesiology, Showa University School of Dentistry, 2-1-1 Kitasenzoku, Ota-ku, Tokyo 145-8515, Japan
Satoru Tsuiki: Research Department, Institute of Neuropsychiatry, 91, Bentencho, Shinjuku-ku, Tokyo 162-0851, Japan

IJERPH, 2023, vol. 20, issue 11, 1-10

Abstract: We hypothesize that the control of tongue position using a newly developed tongue position retainer, where the tongue is held in a protruded position (i.e., intervention A) or in its resting position (i.e., intervention B), is effective for maintaining upper airway patency in obstructive sleep apnea (OSA) compared with no control of tongue position. This is a randomized, controlled, non-blinded, crossover, and two-armed trial (i.e., sequence AB/BA) in 26 male participants (i.e., sample size) who are scheduled to undergo a dental operation under intravenous sedation with OSA (10 ≤ respiratory event index < 30/h). Participants will be randomly allocated into either sequence by a permuted block method, stratified by body mass index. Under intravenous sedation, participants will undergo two interventions, separated by a washout period after receiving intervention A or intervention B using a tongue position retainer after baseline evaluation, before each intervention is provided. The primary outcome is the abnormal breathing index of apnea as determined by the frequency of apnea per hour. We expect that, compared with no control of tongue position, both intervention A and intervention B will improve the abnormal breathing events with superior effects achieved by the former, offering a therapeutic option for OSA.

Keywords: obstructive sleep apnea; randomized controlled trial; intravenous sedation; tongue position retainer (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2023
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