Whole Body Vibration and the Brain in OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

Impact of Whole Body Vibration on Sleep Symptoms and the Brain in Obstructive Sleep Apnea

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04009486
• Other study ID #: 19-006112
• Status: Withdrawn
• Phase: N/A
• Start date: April 2020
• Est. completion date: March 2022

Study information

• Verified date: November 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	after 6 weeks of whole body vibration use
Secondary	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)	after 6 weeks of whole body vibration use
Secondary	Brain Structure	high resolution T1 or T2 (diffusion tensor imaging) examination of brain structure changes (baseline and after 6 weeks)	after 6 weeks of whole body vibration use