Whole Body Vibration and the Brain in OSA

NCT04009486 | Withdrawn

• 1 other identifier: 19-006112
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sleep Symptoms

  after 6 weeks of whole body vibration use

• Brain Structure

  after 6 weeks of whole body vibration use

Study Arms (1)

Obstructive Sleep Apnea

EXPERIMENTAL

Subjects will undergo 6 weeks of whole body vibration.

Device: Whole Body Vibration

Interventions

Whole Body Vibration DEVICE

Subjects will undergo whole body vibration (standing on a "power plate" device 3 times a week, for 30 minute sessions, for 6 weeks)

Obstructive Sleep Apnea

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: April 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: November 19, 2020

Record last verified: 2020-11