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Withdrawn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
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
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)
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
NCT ID
NCT04009486
First Posted
July 2, 2019
Last Updated
November 17, 2020
Sponsor
University of California, Los Angeles
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
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