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

Obstructive Sleep Apnea Clinical Trial

— AP-FLUID  

Official title:

Effects of Physical Activity on OSA Severity Based on the Level of Fluid Shift in Patients Who Can't Use CPAP or MAD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04623463
• Other study ID #: 38RC20.105
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: October 20, 2026

Study information

• Verified date: December 2023
• Source: University Hospital, Grenoble
• Contact: Monique MENDELSON, phD
• Phone: 04 76 76 72 26
• Email: mmendelson[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: October 20, 2026
• Est. primary completion date: October 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
France	UniversityGrenobleHospital	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	HP2 Laboratory

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-Hypopnea index	Measured during polysomnography	Baseline-4weeks
Secondary	Subjective sleepiness as measured by the Epworth Sleepiness Score	Measured with the Epworth Sleepiness Score Questionnaire	Baseline-4weeks
Secondary	Overnight change in leg fluid volume	Measured using bio-electrical impedance	Baseline-4weeks
Secondary	Quality of life assessed by the SF-36 questionnaire	Measured using the SF-36 questionnaire	Baseline-4weeks