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出境医 / 临床实验 / Whole Body Vibration and the Brain in OSA

Whole Body Vibration and the Brain in OSA

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Whole Body Vibration Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Whole Body Vibration on Sleep Symptoms and the Brain in Obstructive Sleep Apnea
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Obstructive Sleep Apnea
Subjects will undergo 6 weeks of whole body vibration.
 Device: Whole Body Vibration
Subjects will undergo whole body vibration (standing on a "power plate" device 3 times a week, for 30 minute sessions, for 6 weeks)
Outcome Measures
Primary Outcome Measures :
  1. Apnea-Hypopnea Index (AHI) [ Time Frame: after 6 weeks of whole body vibration use ]
    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 :
  1. Sleep Symptoms [ Time Frame: after 6 weeks of whole body vibration use ]
    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)

  2. Brain Structure [ Time Frame: after 6 weeks of whole body vibration use ]
    high resolution T1 or T2 (diffusion tensor imaging) examination of brain structure changes (baseline and after 6 weeks)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date November 19, 2020
Estimated Study Start Date  ICMJE April 2020
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019) 		Apnea-Hypopnea Index (AHI) [ Time Frame: after 6 weeks of whole body vibration use ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Sleep Symptoms [ Time Frame: after 6 weeks of whole body vibration use ]
    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 [ Time Frame: after 6 weeks of whole body vibration use ]
    high resolution T1 or T2 (diffusion tensor imaging) examination of brain structure changes (baseline and after 6 weeks)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • Sleep Symptoms [ Time Frame: after 6 weeks of whole body vibration use ]
    symptoms associated with sleep disturbances within the previous month, as recorded by the Pittsburgh Sleep Quality Index Questionnaire
  • Brain Structure [ Time Frame: after 6 weeks of whole body vibration use ]
    high resolution T1 or T2 (diffusion tensor imaging) examination of brain structure changes (baseline and after 6 weeks)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Whole Body Vibration and the Brain in OSA
Official Title  ICMJE Impact of Whole Body Vibration on Sleep Symptoms and the Brain in Obstructive Sleep Apnea
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE Device: Whole Body Vibration
Subjects will undergo whole body vibration (standing on a "power plate" device 3 times a week, for 30 minute sessions, for 6 weeks)
Study Arms  ICMJE Experimental: Obstructive Sleep Apnea
Subjects will undergo 6 weeks of whole body vibration.
Intervention: Device: Whole Body Vibration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 17, 2020) 		0
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2019) 		15
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04009486
Other Study ID Numbers  ICMJE 19-006112
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, Los Angeles
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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