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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02463890
Date of registration:	03/06/2015
Prospective Registration:	Yes
Primary sponsor:	Centre Hospitalier Universitaire de Saint Etienne
Public title:	Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity EXESAS
Scientific title:	Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity
Date of first enrolment:	June 8, 2015
Target sample size:	96
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02463890
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	Frederic ROCHE, MD - PhD
Address:
Telephone:
Email:
Affiliation:	CHU de Saint-Etienne

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients affiliated or entitled to a social security system

- Patients with AHI from 15 to 30 per hour

- Signature of consent

Exclusion Criteria:

- Patients being already treated for sleep apnea or clinical status (cardiovascular
comorbidities) justifying an immediate initiation of CPAP

- Daytime sleepiness (ESS score > 10)

- Known respiratory or heart disease (or discovering during stress test) contraindicated
exercise training

- Patients with Parkinson's disease

Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sleep Apnea, Obstructives

Sleep Apnea Syndromes

Intervention(s)

Other: Control

Other: Training

Primary Outcome(s)

Final polysomnography [Time Frame: 9 months]

Secondary Outcome(s)

Berlin questionnaire [Time Frame: 9 months]

Population Physical Activity questionnaire (POPAQ) [Time Frame: 9 months]

Blood pressure - Baroreflex [Time Frame: 9 months]

Second intermediate polysomnography [Time Frame: 6 months]

Daily physical activity energy expenditure [Time Frame: 9 months]

High frequency [Time Frame: 9 months]

Maximal aerobic capacity (VO2Max) [Time Frame: 9 months]

Pittsburgh questionnaire [Time Frame: 9 months]

Epworth sleepiness Scale [Time Frame: 9 months]

First intermediate polysomnography [Time Frame: 3 months]

Secondary ID(s)

1508033

2015-A00490-49

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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