search
Back to results

Whole Body Vibration and the Brain in OSA

Primary Purpose

Obstructive Sleep Apnea

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whole Body Vibration
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • AHI ≥15
  • new diagnosis of moderate to severe OSA (via overnight polysomnography)
  • and able to lay flat (requirement for brain MRI)
  • must have space and electrical power access for WBV device at their home

Exclusion Criteria:

  • other forms of sleep-disordered breathing (such as central sleep apnea, restless legs syndrome, mixed sleep apnea)
  • currently using (or will start using during 6-week study period) CPAP or BiPAP or oral appliance for OSA treatment
  • recent (<6 months) myocardial infarction
  • current pregnancy (if subject is female)
  • history of stroke
  • diagnosed psychiatric disease (schizophrenia, manic-depressive)
  • airway or chest deformities that would interfere with breathing
  • mechanical ventilatory support
  • renal failure (requiring dialysis)

For brain MRI

  • claustrophobia
  • metallic-based tattoos
  • metallic implants or devices (such as implantable cardioverter-defibrillator, pacemaker, embolic coils, aneurysm clips) or any other material that could be hazardous in MRI scanner
  • body weight >300 lbs (restrictions of MRI scanner table)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Obstructive Sleep Apnea

    Arm Description

    Subjects will undergo 6 weeks of whole body vibration.

    Outcomes

    Primary Outcome Measures

    Apnea-Hypopnea Index (AHI)
    average number of times per hour during the sleep study/overnight polysomnography that the subject's arterial blood oxygen saturation drops by over 10% from waking baseline

    Secondary Outcome Measures

    Sleep Symptoms
    symptoms associated with sleep disturbances within the previous month, as recorded by the Pittsburgh Sleep Quality Index Questionnaire (measures sleep symptoms, such as fatigue, sleep quality, sleep duration, etc.The PSQI is a 19-item self-report questionnaire which queries the subject regarding sleep symptoms for the month before the instrument's administration. Each question is rated on a 0-3-point scale, with a total score range of 0-21. Higher scores indicate worse sleep symptoms. A global sum of > 5 indicates a "poor" sleeper. The PSQI has good validity when compared with overnight polysomnography measures and acceptable reliability (Cronbach's alpha > 0.7; test-retest reliability 0.72-0.86)
    Brain Structure
    high resolution T1 or T2 (diffusion tensor imaging) examination of brain structure changes (baseline and after 6 weeks)

    Full Information

    First Posted
    July 2, 2019
    Last Updated
    November 17, 2020
    Sponsor
    University of California, Los Angeles
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04009486
    Brief Title
    Whole Body Vibration and the Brain in OSA
    Official Title
    Impact of Whole Body Vibration on Sleep Symptoms and the Brain in Obstructive Sleep Apnea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Not approved for funding
    Study Start Date
    April 2020 (Anticipated)
    Primary Completion Date
    March 2022 (Anticipated)
    Study Completion Date
    March 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Los Angeles

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Participants will have an overnight polysomnography (recording apnea-hypopnea index), MRI (brain structure), and a sleep symptoms questionnaire for baseline data. Participants will then undergo 6 weeks of whole body vibration (using the whole body vibration device), 3 times a week for 30 minutes sessions. After 6 weeks, participants will have complete another polysomnography, MRI and sleep questionnaire.
    Detailed Description
    OSA subjects will be recruited from the UCLA Sleep Disorders Center via recruitment flyers. When prospective subjects contact the study coordinator, the study will be explained in greater detail, and inclusion and exclusion criteria reviewed. If the person agrees to participate, appointments for data collection will be made and copies of the informed consent will be mailed for their review for at least 3 days before the study. Then the Project Coordinator or one of the PI's will contact the prospective subject, answer any questions about the study, and obtain signed, informed consent. Baseline measures (PSQI, BDI-II, height, weight, vital signs [temperature, heart rate, blood pressure]) will be obtained. At 6 weeks, baseline measures will be repeated and an overnight polysomnography study will be performed at the subject's home. All subjects will be given the WBV device at the end of the study. Delivery of the WBV device to each subject's home will be arranged and the WBV device and pedometer set up by the research team. Training in the use of the WBV device will be provided inperson and via written instructions. Phone and e-mail support for the WBV device or any study questions will be available for all study participants. Subjects will use the device at least 3 times/week, for 30 minutes per session, for 6 weeks. In addition to the pedometer, a wall calendar will be provided on which subjects will mark the days that they use the WBV device. Project Coordinator will visit subjects weekly, and as needed, to record pedometer readings, check wall calendar for WBV device use, and to answer any subjects' questions or concerns. Brain MRI scans will be performed at baseline and after 6 weeks. An MRI-compatible pulse oximeter, and an air-filled pressure transducer will be connected to the subject to monitor heart rate, O2 saturation, and thoracic wall movement, and then the subject will be positioned in the scanner for data collection.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Obstructive Sleep Apnea
    Arm Type
    Experimental
    Arm Description
    Subjects will undergo 6 weeks of whole body vibration.
    Intervention Type
    Device
    Intervention Name(s)
    Whole Body Vibration
    Intervention Description
    Subjects will undergo whole body vibration (standing on a "power plate" device 3 times a week, for 30 minute sessions, for 6 weeks)
    Primary Outcome Measure Information:
    Title
    Apnea-Hypopnea Index (AHI)
    Description
    average number of times per hour during the sleep study/overnight polysomnography that the subject's arterial blood oxygen saturation drops by over 10% from waking baseline
    Time Frame
    after 6 weeks of whole body vibration use
    Secondary Outcome Measure Information:
    Title
    Sleep Symptoms
    Description
    symptoms associated with sleep disturbances within the previous month, as recorded by the Pittsburgh Sleep Quality Index Questionnaire (measures sleep symptoms, such as fatigue, sleep quality, sleep duration, etc.The PSQI is a 19-item self-report questionnaire which queries the subject regarding sleep symptoms for the month before the instrument's administration. Each question is rated on a 0-3-point scale, with a total score range of 0-21. Higher scores indicate worse sleep symptoms. A global sum of > 5 indicates a "poor" sleeper. The PSQI has good validity when compared with overnight polysomnography measures and acceptable reliability (Cronbach's alpha > 0.7; test-retest reliability 0.72-0.86)
    Time Frame
    after 6 weeks of whole body vibration use
    Title
    Brain Structure
    Description
    high resolution T1 or T2 (diffusion tensor imaging) examination of brain structure changes (baseline and after 6 weeks)
    Time Frame
    after 6 weeks of whole body vibration use

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: AHI ≥15 new diagnosis of moderate to severe OSA (via overnight polysomnography) and able to lay flat (requirement for brain MRI) must have space and electrical power access for WBV device at their home Exclusion Criteria: other forms of sleep-disordered breathing (such as central sleep apnea, restless legs syndrome, mixed sleep apnea) currently using (or will start using during 6-week study period) CPAP or BiPAP or oral appliance for OSA treatment recent (<6 months) myocardial infarction current pregnancy (if subject is female) history of stroke diagnosed psychiatric disease (schizophrenia, manic-depressive) airway or chest deformities that would interfere with breathing mechanical ventilatory support renal failure (requiring dialysis) For brain MRI claustrophobia metallic-based tattoos metallic implants or devices (such as implantable cardioverter-defibrillator, pacemaker, embolic coils, aneurysm clips) or any other material that could be hazardous in MRI scanner body weight >300 lbs (restrictions of MRI scanner table)

    12. IPD Sharing Statement

    Learn more about this trial

    Whole Body Vibration and the Brain in OSA

    We'll reach out to this number within 24 hrs