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

NCT ID: NCT04623463

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-20
• Study Completion Date: 2026-10-20

Brief 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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise intervention

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.

Group Type: OTHER

Physical activity intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Physical activity intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• • Patient aged 18 to 80 years old

• Patient with OSA (AHI ≥ 15 events/hr)
• Patient not receiving any treatment for their OSA
• Patient able to provide written informed consent
• Patient able to participate in regular physical activity (no medical contraindication to exercise)

Exclusion Criteria

• • Pregnancy

• Person deprived of liberty or subject to a legal protection measure
• Patient presenting a condition that can influence the results. (According to the investigator's judgment, i.e. heart failure, venous insufficiency).
• Vulnerable person or legally protected adult.
• Patients already included in another interventional study
• BMI > 30 kg/m²
• Patient taking diuretics

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HP2 Laboratory

UNKNOWN

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UniversityGrenobleHospital

Grenoble, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Monique MENDELSON, phD

Role: CONTACT

mmendelson@chu-grenoble.fr

04 76 76 72 26

Facility Contacts

Monique Mendelson, PhD

Role: primary

monique.mendelson@univ-grenoble-alpes.fr

33-476764265

Other Identifiers

38RC20.105

Identifier Type: -

Identifier Source: org_study_id