Clinical Trial

Effects of Physical Activity on OSA Severity Based on the Level of Fluid Shift

Study acronym: AP-FLUID
Recruiting
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Summary
Obstructive sleep apnea (OSA) is characterized by complete or partial upper-airway collapse during sleep associated with sleepiness. OSA causes severe impairments in quality of life (sleepiness, tiredness, concentration difficulties). Moreover, OSA has adverse consequences on the cardiovascular system by causing intermittent hypoxia, increased sympathetic nervous system activation and vascular endothelial dysfunction. Continuous Positive Airway Pressure (CPAP) and mandibular advanced devices (MAD) remain the two first-line therapies for OSA. However, not all patients are eligible for these treatments or are not able to follow for a lifelong therapy and therefore do not use it consistently. A recent meta-analysis has confirmed that regular physical activity reduces OSA by approximately 28% (Mendelson et al. 2018). However, an important inter-individual variability exists and no study to date has identified characteristics of patients who respond to these interventions. The aim of this Prospective study, single-site, non-randomized 4-week trial is to evaluate the impact of a 4-week physical activity intervention on the apnea-hypopnea index (AHI) in OSA patients based on their baseline fluid shift level. Participants included in the present study will benefit from a 4-week physical activity intervention. Upon the initial visit, a physical activity prescription will be defined and they will be equipped with a physical activity monitor that allows feedback. Participants will then exercise one day per week on-site and 4 days/week on their own. Weekly physical activity will be reviewed weekly with the participant during their on-site visit.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2020-11-04.
Trial Details
NCT Number NCT04623463
Lead Sponsor University Hospital, Grenoble
Collaborators: HP2 Laboratory
Conditions Obstructive Sleep Apnea
Enrollment 62 participants
Start Date 2020-10-20
Primary Completion 2026-10-20 (estimated)
Study Completion 2026-10-20 (estimated)
Updated on ClinicalTrials.gov 2024-01-03