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

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...

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Autores principales: Fukuda, Tatsuya, Kohzuka, Yuuya, Almeida, Fernanda R., Iijima, Takehiko, Masuda, Rikuo, Tsuiki, Satoru
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10252218/
https://www.ncbi.nlm.nih.gov/pubmed/37297630
http://dx.doi.org/10.3390/ijerph20116026
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author Fukuda, Tatsuya
Kohzuka, Yuuya
Almeida, Fernanda R.
Iijima, Takehiko
Masuda, Rikuo
Tsuiki, Satoru
author_facet Fukuda, Tatsuya
Kohzuka, Yuuya
Almeida, Fernanda R.
Iijima, Takehiko
Masuda, Rikuo
Tsuiki, Satoru
author_sort Fukuda, Tatsuya
collection PubMed
description 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.
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spelling pubmed-102522182023-06-10 Control of Tongue Position in Patients with Obstructive Sleep Apnea: Concept and Protocol for a Randomized Controlled Crossover Trial Fukuda, Tatsuya Kohzuka, Yuuya Almeida, Fernanda R. Iijima, Takehiko Masuda, Rikuo Tsuiki, Satoru Int J Environ Res Public Health Study Protocol 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. MDPI 2023-06-01 /pmc/articles/PMC10252218/ /pubmed/37297630 http://dx.doi.org/10.3390/ijerph20116026 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Study Protocol
Fukuda, Tatsuya
Kohzuka, Yuuya
Almeida, Fernanda R.
Iijima, Takehiko
Masuda, Rikuo
Tsuiki, Satoru
Control of Tongue Position in Patients with Obstructive Sleep Apnea: Concept and Protocol for a Randomized Controlled Crossover Trial
title Control of Tongue Position in Patients with Obstructive Sleep Apnea: Concept and Protocol for a Randomized Controlled Crossover Trial
title_full Control of Tongue Position in Patients with Obstructive Sleep Apnea: Concept and Protocol for a Randomized Controlled Crossover Trial
title_fullStr Control of Tongue Position in Patients with Obstructive Sleep Apnea: Concept and Protocol for a Randomized Controlled Crossover Trial
title_full_unstemmed Control of Tongue Position in Patients with Obstructive Sleep Apnea: Concept and Protocol for a Randomized Controlled Crossover Trial
title_short Control of Tongue Position in Patients with Obstructive Sleep Apnea: Concept and Protocol for a Randomized Controlled Crossover Trial
title_sort control of tongue position in patients with obstructive sleep apnea: concept and protocol for a randomized controlled crossover trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10252218/
https://www.ncbi.nlm.nih.gov/pubmed/37297630
http://dx.doi.org/10.3390/ijerph20116026
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