Whole Body Vibration & the Brain in OSA

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04009486
Study type	Interventional
Source	University of California, Los Angeles
Contact
Status	Withdrawn
Phase	N/A
Start date	April 2020
Completion date	March 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Whole Body Vibration and the Brain in OSA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms