Obstructive Sleep Apnea and a Comprehensive Remotely Supervised
Rehabilitation Program: Protocol for a Randomized Controlled
Trial.

J 2023

Obstructive Sleep Apnea and a Comprehensive Remotely Supervised Rehabilitation Program: Protocol for a Randomized Controlled Trial.

HNATIAK, Jakub, Lujza ZIKMUND GALKOVÁ, Petr WINNIGE, Ladislav BAŤALÍK, Filip DOSBABA et. al.

Basic information

Original name

Obstructive Sleep Apnea and a Comprehensive Remotely Supervised Rehabilitation Program: Protocol for a Randomized Controlled Trial.

Authors

HNATIAK, Jakub (203 Czech Republic, belonging to the institution), Lujza ZIKMUND GALKOVÁ (703 Slovakia, belonging to the institution), Petr WINNIGE (203 Czech Republic, belonging to the institution), Ladislav BAŤALÍK (203 Czech Republic, belonging to the institution), Filip DOSBABA (203 Czech Republic), Ondřej LUDKA (203 Czech Republic) and Jan KREJČÍ (203 Czech Republic, belonging to the institution)

Edition

JMIR Research Protocols, TORONTO, JMIR PUBLICATIONS, 2023, 1929-0748

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30304 Public and environmental health

Country of publisher

Canada

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 1.700 in 2022

RIV identification code

RIV/00216224:14110/23:00131769

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.2196/47460

UT WoS

001089675500004

Keywords in English

CPAP; RCT; apnea-hypopnea index; home based; obstructive sleep apnea; randomized controlled trial; rehabilitation; respiratory; sleep; telehealth; telemedicine; telemonitoring; telerehabilitation.

Abstract

V originále

Background: Obstructive sleep apnea (OSA) is characterized by recurrent, intermittent partial or complete obstruction of the upper respiratory tract during sleep, which negatively affects the patient's daily quality of life (QoL). Middle-aged and older men who smoke and have obesity are most at risk. Even though the use of continuous positive airway pressure (CPAP) during sleep remains the gold standard treatment, various rehabilitation methods, such as exercise, respiratory therapy, myofunctional therapy, and nutritional lifestyle interventions, also appear to be effective. Moreover, it is increasingly recommended to use alternative or additional therapy options in combination with CPAP therapy. Objective: This study aims to evaluate if a comprehensive home-based, remotely supervised rehabilitation program (tele-RHB), in combination with standard therapy, can improve OSA severity by decreasing the apnea-hypopnea index (AHI); improve objective parameters of polysomnographic, spirometric, anthropometric, and body composition examinations; improve lipid profile, maximal mouth pressure, and functional capacity tests; and enhance the subjective perception of QoL, as well as daytime sleepiness in male participants with moderate to severe OSA. Our hypothesis is that a combination of the tele-RHB program and CPAP therapy will be more effective by improving OSA severity and the abovementioned parameters. Methods: This randomized controlled trial aims to recruit 50 male participants between the ages of 30 and 60 years with newly diagnosed moderate to severe OSA. Participants will be randomized 1:1, either to a 12-week tele-RHB program along with CPAP therapy or to CPAP therapy alone. After the completion of the intervention, the participants will be invited to complete a 1-year follow-up. The primary outcomes will be the polysomnographic value of AHI, Epworth Sleepiness Scale score, 36-Item Short Form Health Survey (SF-36) score, percentage of body fat, 6-minute walk test distance covered, as well as maximal inspiratory and expiratory mouth pressure values. Secondary outcomes will include polysomnographic values of oxygen desaturation index, supine AHI, total sleep time, average heart rate, mean oxygen saturation, and the percentage of time with oxygen saturation below 90%; anthropometric measurements of neck, waist, and hip circumference; BMI values; forced vital capacity; forced expiratory volume in 1 second; World Health Organization's tool to measure QoL (WHOQOL-BREF) score; and lipid profile values. Results: Study recruitment began on October 25, 2021, and the estimated study completion date is December 2024. Analyses will be performed to examine whether the combination of the tele-RHB program and CPAP therapy will be more effective in the reduction of OSA severity and improvement of QoL, body composition and circumferences, exercise tolerance, lipid profile, as well as respiratory muscle and lung function, compared to CPAP therapy alone. Conclusions: The study will evaluate the effect of a comprehensive tele-RHB program on selected parameters mentioned above in male participants. The results of this intervention could help the further development of novel additional therapeutic home-based options for OSA.

Citovat

HNATIAK, Jakub, Lujza ZIKMUND GALKOVÁ, Petr WINNIGE, Ladislav BAŤALÍK, Filip DOSBABA, Ondřej LUDKA and Jan KREJČÍ. Obstructive Sleep Apnea and a Comprehensive Remotely Supervised Rehabilitation Program: Protocol for a Randomized Controlled Trial. JMIR Research Protocols. TORONTO: JMIR PUBLICATIONS, 2023, vol. 12, September 2023, p. 1-9. ISSN 1929-0748. Available from: https://dx.doi.org/10.2196/47460.

@article{2317257,
   author = {Hnatiak, Jakub and Zikmund Galková, Lujza and Winnige, Petr and Baťalík, Ladislav and Dosbaba, Filip and Ludka, Ondřej and Krejčí, Jan},
   article_location = {TORONTO},
   article_number = {September 2023},
   doi = {http://dx.doi.org/10.2196/47460},
   keywords = {CPAP; RCT; apnea-hypopnea index; home based; obstructive sleep apnea; randomized controlled trial; rehabilitation; respiratory; sleep; telehealth; telemedicine; telemonitoring; telerehabilitation.},
   language = {eng},
   issn = {1929-0748},
   journal = {JMIR Research Protocols},
   title = {Obstructive Sleep Apnea and a Comprehensive Remotely Supervised Rehabilitation Program: Protocol for a Randomized Controlled Trial.},
   url = {https://www.researchprotocols.org/2023/1/e47460},
   volume = {12},
   year = {2023}
}

TY  - JOUR
ID  - 2317257
AU  - Hnatiak, Jakub - Zikmund Galková, Lujza - Winnige, Petr - Baťalík, Ladislav - Dosbaba, Filip - Ludka, Ondřej - Krejčí, Jan
PY  - 2023
TI  - Obstructive Sleep Apnea and a Comprehensive Remotely Supervised Rehabilitation Program: Protocol for a Randomized Controlled Trial.
JF  - JMIR Research Protocols
VL  - 12
IS  - September 2023
SP  - 1-9
EP  - 1-9
PB  - JMIR PUBLICATIONS
SN  - 19290748
KW  - CPAP
KW  - RCT
KW  - apnea-hypopnea index
KW  - home based
KW  - obstructive sleep apnea
KW  - randomized controlled trial
KW  - rehabilitation
KW  - respiratory
KW  - sleep
KW  - telehealth
KW  - telemedicine
KW  - telemonitoring
KW  - telerehabilitation.
UR  - https://www.researchprotocols.org/2023/1/e47460
N2  - Background: Obstructive sleep apnea (OSA) is characterized by recurrent, intermittent partial or complete obstruction of the upper respiratory tract during sleep, which negatively affects the patient's daily quality of life (QoL). Middle-aged and older men who smoke and have obesity are most at risk. Even though the use of continuous positive airway pressure (CPAP) during sleep remains the gold standard treatment, various rehabilitation methods, such as exercise, respiratory therapy, myofunctional therapy, and nutritional lifestyle interventions, also appear to be effective. Moreover, it is increasingly recommended to use alternative or additional therapy options in combination with CPAP therapy. Objective: This study aims to evaluate if a comprehensive home-based, remotely supervised rehabilitation program (tele-RHB), in combination with standard therapy, can improve OSA severity by decreasing the apnea-hypopnea index (AHI); improve objective parameters of polysomnographic, spirometric, anthropometric, and body composition examinations; improve lipid profile, maximal mouth pressure, and functional capacity tests; and enhance the subjective perception of QoL, as well as daytime sleepiness in male participants with moderate to severe OSA. Our hypothesis is that a combination of the tele-RHB program and CPAP therapy will be more effective by improving OSA severity and the abovementioned parameters. Methods: This randomized controlled trial aims to recruit 50 male participants between the ages of 30 and 60 years with newly diagnosed moderate to severe OSA. Participants will be randomized 1:1, either to a 12-week tele-RHB program along with CPAP therapy or to CPAP therapy alone. After the completion of the intervention, the participants will be invited to complete a 1-year follow-up. The primary outcomes will be the polysomnographic value of AHI, Epworth Sleepiness Scale score, 36-Item Short Form Health Survey (SF-36) score, percentage of body fat, 6-minute walk test distance covered, as well as maximal inspiratory and expiratory mouth pressure values. Secondary outcomes will include polysomnographic values of oxygen desaturation index, supine AHI, total sleep time, average heart rate, mean oxygen saturation, and the percentage of time with oxygen saturation below 90%; anthropometric measurements of neck, waist, and hip circumference; BMI values; forced vital capacity; forced expiratory volume in 1 second; World Health Organization's tool to measure QoL (WHOQOL-BREF) score; and lipid profile values. Results: Study recruitment began on October 25, 2021, and the estimated study completion date is December 2024. Analyses will be performed to examine whether the combination of the tele-RHB program and CPAP therapy will be more effective in the reduction of OSA severity and improvement of QoL, body composition and circumferences, exercise tolerance, lipid profile, as well as respiratory muscle and lung function, compared to CPAP therapy alone. Conclusions: The study will evaluate the effect of a comprehensive tele-RHB program on selected parameters mentioned above in male participants. The results of this intervention could help the further development of novel additional therapeutic home-based options for OSA.
ER  -

HNATIAK, Jakub, Lujza ZIKMUND GALKOVÁ, Petr WINNIGE, Ladislav BAŤALÍK, Filip DOSBABA, Ondřej LUDKA and Jan KREJČÍ. Obstructive Sleep Apnea and a Comprehensive Remotely Supervised Rehabilitation Program: Protocol for a Randomized Controlled Trial. \textit{JMIR Research Protocols}. TORONTO: JMIR PUBLICATIONS, 2023, vol.~12, September 2023, p.~1-9. ISSN~1929-0748. Available from: https://dx.doi.org/10.2196/47460.

Detailed Information on Publication Record