SEARCHRCTpulmonology, internal medicine

RCT·pulmonology, internal medicine, cardiology, clinical trial, nutrition·PMC10546260

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

JMIR Research Protocols · 7 authors, 5 centres

AI SUMMARY

FIDELITY 100%

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

“

TL;DR

This is a protocol for a randomized controlled trial that will compare a 12-week home-based, remotely supervised rehabilitation program combined with CPAP therapy against CPAP therapy alone in 50 male participants with moderate to severe obstructive sleep apnea. No results have been reported yet; the study aims to evaluate effects on apnea-hypopnea index, quality of life, body composition, exercise tolerance, lipid profile, and respiratory muscle function.

Full summary

1,032 CHARS

This paper describes the protocol for a randomized controlled trial evaluating whether a comprehensive remotely supervised rehabilitation program (tele-RHB), combined with CPAP therapy, is superior to CPAP therapy alone for improving outcomes in men with moderate to severe OSA. Fifty male participants aged 30 to 60 years will be randomized 1:1 to receive either the 12-week tele-RHB program alongside CPAP or CPAP alone, with a planned 1-year follow-up. The tele-RHB program incorporates aerobic exercise training, oropharyngeal training, respiratory muscle training, and nutritional, lifestyle, and behavior change recommendations delivered via teleconsultations. Secondary outcomes encompass oxygen desaturation index, anthropometric measures, spirometry, WHOQOL-BREF, and lipid profile. Recruitment began October 25, 2021, with estimated completion December 2024. As a protocol paper, no outcome data are reported; a recognized limitation is the absence of direct physiotherapist supervision during the home-based intervention.

STUDY TYPE

RCT

SPECIALTY

pulmonology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10546260

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

JMIR Research Protocols

READ THE FULL PAPER

ABSTRACT

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. Trial Registration ClinicalTrials.gov NCT04759456 ; https://clinicaltrials.gov/ct2/show/ NCT04759456 International Registered Report Identifier (IRRID) DERR1-10.2196/47460

CITATION EXPORT

Jakub Hnatiak, Lujza Zikmund Galkova, Petr Winnige et al.. Obstructive Sleep Apnea and a Comprehensive Remotely Supervised Rehabilitation Program: Protocol for a Randomized Controlled Trial. JMIR Research Protocols. (2023). https://doi.org/10.2196/47460

AUTHORS

7 · 5 CENTRES

Jakub Hnatiak, Lujza Zikmund Galkova, Petr Winnige, Ladislav Batalik, Filip Dosbaba, Ondrej Ludka, Jan Krejci

1 Department of Rehabilitation University Hospital Brno Brno Czech Republic
2 First Department of Internal Medicine - Cardioangiology, St Anne´s University Hospital Faculty of Medicine Masaryk University Brno Czech Republic
3 Cardiovascular Sleep Center of the First Department of Internal Medicine - Cardioangiology, St Anne´s University Hospital Brno Czech Republic
4 Department of Public Health Faculty of Medicine Masaryk University Brno Czech Republic
5 Department of Internal Medicine, Geriatrics and Practical Medicine University Hospital Brno Brno Czech Republic

EDITOR / REVIEWER

Amaryllis Mavragani, Joshua Roland, Carlos O'Connor-Reina