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

Primary Purpose

Obstructive Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity intervention
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UniversityGrenobleHospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Exercise intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Apnea-Hypopnea index
Measured during polysomnography

Secondary Outcome Measures

Epworth score
Measured with the Epworth Sleepiness Score Questionnaire
Overnight change in leg fluid volume
Measured using bio-electrical impedance
Quality of life - physical and mental components
Measured using the SF-36 questionnaire

Full Information

First Posted
November 4, 2020
Last Updated
November 4, 2020
Sponsor
University Hospital, Grenoble
Collaborators
HP2 Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT04623463
Brief Title
Effects of Physical Activity on OSA Severity Based on the Level of Fluid Shift
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
October 20, 2022 (Anticipated)
Study Completion Date
November 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
HP2 Laboratory

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise intervention
Arm Type
Other
Arm Description
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
Intervention Name(s)
Physical activity intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Apnea-Hypopnea index
Description
Measured during polysomnography
Time Frame
Baseline-4weeks
Secondary Outcome Measure Information:
Title
Epworth score
Description
Measured with the Epworth Sleepiness Score Questionnaire
Time Frame
Baseline-4weeks
Title
Overnight change in leg fluid volume
Description
Measured using bio-electrical impedance
Time Frame
Baseline-4weeks
Title
Quality of life - physical and mental components
Description
Measured using the SF-36 questionnaire
Time Frame
Baseline-4weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monique MENDELSON, phD
Phone
04 76 76 72 26
Email
mmendelson@chu-grenoble.fr
Facility Information:
Facility Name
UniversityGrenobleHospital
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monique Mendelson, PhD
Phone
33-476764265
Email
monique.mendelson@univ-grenoble-alpes.fr
First Name & Middle Initial & Last Name & Degree
Renaud Tamisier, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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