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Controlled Exercises Effectiveness in Patients With Sleep Apnea

Sponsor
Universidad Complutense de Madrid (Other)
Overall Status
Unknown status
CT.gov ID
NCT04326634
Collaborator
(none)
30
Enrollment
2
Arms
15
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim is to compare a programme of controlled exercises therapy vs a programme of non controlled exercises therapy in patients with sleep apnea

Condition or Disease Intervention/Treatment Phase
  • Other: controlled exercises
  • Other: non controlled exercises group
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Controlled Exercises Effectiveness in Patients With Sleep Apnea
Anticipated Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Controlled exercises Group

Other: controlled exercises
controlled exercises

Other: non controlled exercises group
non controlled exercises
Experimental: Non controlled exercises Group

Other: controlled exercises
controlled exercises

Other: non controlled exercises group
non controlled exercises

Outcome Measures

Primary Outcome Measures

  1. awake episodes [immediately after treatment]

    number of awake episodes

  2. awake episodes [3 months]

    number of awake episodes

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • sleep apnea
Exclusion Criteria:
  • neurologic disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universidad Complutense de Madrid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gema Serrano-Hernanz, PhD, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:
NCT04326634
Other Study ID Numbers:
  • Geserher
First Posted:
Mar 30, 2020
Last Update Posted:
Mar 30, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes

Study Results

No Results Posted as of Mar 30, 2020