- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04326634
Controlled Exercises Effectiveness in Patients With Sleep Apnea
March 26, 2020 updated by: Gema Serrano-Hernanz, Universidad Complutense de Madrid
The aim is to compare a programme of controlled exercises therapy vs a programme of non controlled exercises therapy in patients with sleep apnea
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gema Serrano-Hernanz, PhD
- Phone Number: 669332986
- Email: gema.serrano.hernanz@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- sleep apnea
Exclusion Criteria:
- neurologic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Controlled exercises Group
|
controlled exercises
non controlled exercises
|
Experimental: Non controlled exercises Group
|
controlled exercises
non controlled exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
awake episodes
Time Frame: immediately after treatment
|
number of awake episodes
|
immediately after treatment
|
awake episodes
Time Frame: 3 months
|
number of awake episodes
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2020
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
March 19, 2020
First Submitted That Met QC Criteria
March 26, 2020
First Posted (Actual)
March 30, 2020
Study Record Updates
Last Update Posted (Actual)
March 30, 2020
Last Update Submitted That Met QC Criteria
March 26, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Geserher
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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