Whole Body Vibration for OSA

NCT03377621 | Withdrawn FDA Device

• 1 other identifier: 17-001323
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive Sleep Apnea (OSA) is a serious medical condition which is increasing in the United States and significantly increases risks for other diseases, morbidity and mortality. The most common treatment for OSA is CPAP (Continuous Positive Airway Pressure), but this intervention has low patient compliance, significant expense ($800-2,000/set), and high inconvenience. Whole Body Vibration (WBV) training is a novel OSA intervention which could have higher patient compliance, low expense, and potentially lower morbidity and mortality and improved quality of life in this increasing patient population.

Conditions

Obstructive Sleep Apnea

Keywords

whole body vibration; sleep; apnea

Outcome Measures

Primary Outcomes (2)

• Change from Baseline OSA Severity at 6 weeks

  OSA severity as measured by Apnea-Hypopnea Index (AHI)

  Baseline and 6 weeks

• Change from Baseline Brain Structure at 6 weeks

  Brain structure as measured by brain magnetic resonance imaging

  Baseline and 6 weeks

Secondary Outcomes (3)

• Change from Baseline PSQI at 6 weeks

  Baseline and 6 weeks

• Change from Baseline Nonin Wristox Measurement at 6 Weeks

  Baseline and 6 weeks

• Change in Baseline Balance at 6 weeks

  Baseline and 6 weeks

Study Arms (1)

Whole Body Vibration

EXPERIMENTAL

OSA subjects will be asked to use whole body vibration machine for 30 minutes, 3 times a week for 6 weeks in between visits.

Device: Whole Body Vibration

Interventions

Whole Body Vibration DEVICE

Whole Body Vibration Machine from the company Confidence Fitness

Whole Body Vibration

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must be between ages 21-60
• Clinical diagnosis of moderate-to-severe OSA (AHI \> 15)
• Must be able to stand up for 30 mins at a time with no joint or muscular problems
• Must have adequate space/power in home to run the WBV machine

You may not qualify if:

• Previous history of stroke and/or myocardial infarction
• Diagnosed neuropsychological and neuropsychiatric diseases,
• Airway or chest deformities that would interfere with breathing,
• Chronic obstructive pulmonary disease,
• Cystic fibrosis
• Presence of brain mass lesions
• Any history of drug abuse (e.g., cocaine or tobacco)
• History of renal failure (requiring dialysis).
• Pregnancy (if female) due to the potential dangers to the fetus from the MRI
• Subjects with contraindications to MRI:
• Metallic and electronic implants (phrenic or cardiac pacemakers), braces, or metallic-based tattoos
• Body weight \> 275 pound
• Claustrophobia
• Inadequate space/ electronic power in home to run the WBV machine.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

300 Medical Plaza

Los Angeles, California, 90095, United States

Location

Related Publications (4)

• Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.

  PMID: 23589584 BACKGROUND

• Castronovo V, Scifo P, Castellano A, Aloia MS, Iadanza A, Marelli S, Cappa SF, Strambi LF, Falini A. White matter integrity in obstructive sleep apnea before and after treatment. Sleep. 2014 Sep 1;37(9):1465-75. doi: 10.5665/sleep.3994.

  PMID: 25142557 BACKGROUND

• Billings ME, Auckley D, Benca R, Foldvary-Schaefer N, Iber C, Redline S, Rosen CL, Zee P, Kapur VK. Race and residential socioeconomics as predictors of CPAP adherence. Sleep. 2011 Dec 1;34(12):1653-8. doi: 10.5665/sleep.1428.

  PMID: 22131602 BACKGROUND

• Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008 Feb 15;5(2):173-8. doi: 10.1513/pats.200708-119MG.

  PMID: 18250209 BACKGROUND

Related Links

• National Healthy Sleep Awareness Project

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Apnea

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary A Woo, PhD, RN

  UCLA School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: One group will receive intervention and will be evaluated before and after intervention.

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 19, 2017
• Study Start: December 2, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be made available 6 months after study completion
• Access Criteria: Applicant must e-mail the principal investigator to request access and must submit specific aims and data analysis plans for the information. Applicant must have an academic e-mail (i.e., affiliated with a research academic institution, such as an accredited university or research agency - examples: NIH, RAND Corporation, University of Pennsylvania, etc)

Locations

US (1)