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Effects of Physical Activity on OSA Severity Based on the Level of Fluid Shift (AP-FLUID)

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ClinicalTrials.gov Identifier: NCT04623463
Recruitment Status : Recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborator:
HP2 Laboratory
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Behavioral: Physical activity intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : October 20, 2022
Estimated Study Completion Date : November 20, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Apnea-Hypopnea index [ Time Frame: Baseline-4weeks ]
    Measured during polysomnography


Secondary Outcome Measures :
  1. Epworth score [ Time Frame: Baseline-4weeks ]
    Measured with the Epworth Sleepiness Score Questionnaire

  2. Overnight change in leg fluid volume [ Time Frame: Baseline-4weeks ]
    Measured using bio-electrical impedance

  3. Quality of life - physical and mental components [ Time Frame: Baseline-4weeks ]
    Measured using the SF-36 questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04623463


Contacts
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Contact: Monique MENDELSON, phD 04 76 76 72 26 mmendelson@chu-grenoble.fr

Locations
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France
UniversityGrenobleHospital Recruiting
Grenoble, France, 38000
Contact: Monique Mendelson, PhD    33-476764265    monique.mendelson@univ-grenoble-alpes.fr   
Principal Investigator: Renaud Tamisier, MD PhD         
Sponsors and Collaborators
University Hospital, Grenoble
HP2 Laboratory
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04623463    
Other Study ID Numbers: 38RC20.105
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases