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NCT Number: NCT04623463

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UniversityGrenobleHospital

Grenoble, 38000, France

Location status: Recruiting

Location contact

Monique Mendelson, PhD

CONTACT

[email protected]

33-476764265

Renaud Tamisier, MD PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Apnea-Hypopnea index

    Time frame: Baseline-4weeks

    Measured during polysomnography

Secondary outcomes

  1. Subjective sleepiness as measured by the Epworth Sleepiness 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 assessed by the SF-36 questionnaire

    Time frame: Baseline-4weeks

    Measured using the SF-36 questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Monique MENDELSON, phD

CONTACT

[email protected]

04 76 76 72 26

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • HP2 Laboratory

Registry information

Official study title

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

Acronym: AP-FLUID

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2020
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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