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Controlled Exercises Effectiveness in Patients With Sleep Apnea

Primary Purpose

Apnea, Sleep

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
controlled exercises
non controlled exercises group
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apnea, Sleep

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • sleep apnea

Exclusion Criteria:

  • neurologic disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Controlled exercises Group

    Non controlled exercises Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    awake episodes
    number of awake episodes
    awake episodes
    number of awake episodes

    Secondary Outcome Measures

    Full Information

    First Posted
    March 19, 2020
    Last Updated
    March 26, 2020
    Sponsor
    Universidad Complutense de Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04326634
    Brief Title
    Controlled Exercises Effectiveness in Patients With Sleep Apnea
    Official Title
    Controlled Exercises Effectiveness in Patients With Sleep Apnea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2020 (Anticipated)
    Primary Completion Date
    June 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Complutense de Madrid

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Apnea, Sleep

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Controlled exercises Group
    Arm Type
    Experimental
    Arm Title
    Non controlled exercises Group
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    controlled exercises
    Intervention Description
    controlled exercises
    Intervention Type
    Other
    Intervention Name(s)
    non controlled exercises group
    Intervention Description
    non controlled exercises
    Primary Outcome Measure Information:
    Title
    awake episodes
    Description
    number of awake episodes
    Time Frame
    immediately after treatment
    Title
    awake episodes
    Description
    number of awake episodes
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: sleep apnea Exclusion Criteria: neurologic disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gema Serrano-Hernanz, PhD
    Phone
    669332986
    Email
    gema.serrano.hernanz@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Controlled Exercises Effectiveness in Patients With Sleep Apnea

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