Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT04623463

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

Led by University Hospital, Grenoble · Updated on 2024-01-03

62

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Grenoble

Lead Sponsor

H

HP2 Laboratory

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Person deprived of liberty or subject to a legal protection measure
  • Patient with conditions affecting results (e.g., heart failure, venous insufficiency) per investigator judgment
  • Vulnerable person or legally protected adult
  • Patients already in another interventional study
  • Body mass index greater than 30 kg/m�b2
  • Patient taking diuretics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

UniversityGrenobleHospital

Grenoble, France, 38000

Actively Recruiting

Loading map...

Research Team

M

Monique MENDELSON, phD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here