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

NCT04623463 | Recruiting

• 1 other identifier: 38RC20.105
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea index

  Measured during polysomnography

  Baseline-4weeks

Secondary Outcomes (3)

• Subjective sleepiness as measured by the Epworth Sleepiness Score

  Baseline-4weeks

• Overnight change in leg fluid volume

  Baseline-4weeks

• Quality of life assessed by the SF-36 questionnaire

  Baseline-4weeks

Study Arms (1)

Exercise intervention

OTHER

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.

Behavioral: Physical activity intervention

Interventions

Physical activity intervention 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.

Exercise intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• HP2 Laboratory: collaborator

Study Sites (1)

UniversityGrenobleHospital

Grenoble, 38000, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Monique MENDELSON, phD

CONTACT

04 76 76 72 26; mmendelson@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 10, 2020
• Study Start: October 20, 2020
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

FR (1)