search
Back to results

Whole Body Vibration for OSA

Primary Purpose

Obstructive Sleep Apnea

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole Body Vibration
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring whole body vibration, sleep, apnea

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • 300 Medical Plaza

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Whole Body Vibration

Arm Description

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

Outcomes

Primary Outcome Measures

Change from Baseline OSA Severity at 6 weeks
OSA severity as measured by Apnea-Hypopnea Index (AHI)
Change from Baseline Brain Structure at 6 weeks
Brain structure as measured by brain magnetic resonance imaging

Secondary Outcome Measures

Change from Baseline PSQI at 6 weeks
Sleep quality as measured by Pittsburgh Sleep Quality Index (PSQI)
Change from Baseline Nonin Wristox Measurement at 6 Weeks
Sleep quality as measured by Nonin Wristox2
Change in Baseline Balance at 6 weeks
Balance as measured by timing how long subject can balance on dominant foot (in seconds)

Full Information

First Posted
December 6, 2017
Last Updated
September 12, 2019
Sponsor
University of California, Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT03377621
Brief Title
Whole Body Vibration for OSA
Official Title
Whole Body Vibration for Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not funded, and therefore not conducted
Study Start Date
December 2, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Obstructive sleep apnea (OSA) can be defined as temporary cessation of breathing (often from 10-30 seconds) during sleep caused by a blockage of the airways. OSA is increasing in the United States and currently afflicts at least 18 to 25 million adults in the country. OSA is a chronic disease which increases the risk of hypertension, heart disease, Type 2 diabetes, stroke, and depression. OSA also has negative effects on the brain, such as significant reductions in white matter and gray matter, which are accompanied by impairments to cognition, mood, and daytime alertness. At this time, the most common and effective way to treat OSA is with the use of continuous positive airway pressure (CPAP). Adequate CPAP usage (use of the CPAP mask/device for at least 4 hours/night for a minimum of 70% of the nights = 5 days/week) is associated with higher sleep quality, increased daytime alertness, improved mood, better memory, decreased blood pressure, greater cardiac left ventricular ejection fraction, and decreased dysrhythmias. Yet despite the significant benefits of CPAP, compliance (use of CPAP for at least 4 hours per night for at least 5 out of 7 nights/week) with CPAP continues to be low (17-54%). Terri Weaver Predictors of CPAP non-compliance are unclear, but most researchers and clinicians cite OSA patient dislike for the equipment (lots of tubing, sometimes noisy), mask discomfort, and inconvenience. Alternatives to CPAP, such as uvuloectomy and dental jaw devices, are either invasive or have less efficacy in some OSA subjects. One non-invasive method to treat OSA which has not been reported in the literature is whole body vibration (WBV). Whole body vibration refers to any vibration of any frequency which is transferred to the human body. Theoretically, WBV creates eccentric muscle reaction and enables anaerobic activity and was initially designed as a form of resistance training. WBV has been used as a successful treatment for osteoporosis, stroke, leg muscle strength and balance in the elderly. However, it has never been utilized or suggested as a treatment for OSA. In a pilot study conducted by the investigators, they found that 30 minutes of WBV (using a commercially available device which costs $250), 3 times per week, for 6 weeks, dramatically decreased apnea-hypopnea index (AHI; a measure of sleep-disordered breathing) in persons with moderate to severe OSA without changes in weight or injury and that WBV treatment compliance was very good. Yet why would WBV have any impact on OSA? According to the investigators' early studies, stimulation of the proprioception nerves (neural system which allows sensorimotor location of the limbs) stimulates the apneustic center of the lower pons (top of spinal cord), which in turn promotes respiratory inspiration. In the investigators' other studies, they have demonstrated that stimulation of the proprioception nerves during sleep stimulates breathing. However, one might ask if WBV is not being administered during sleep, but only while awake, why would this impact breathing during sleep? It appears that respiratory training while awake continues to have impact during sleep, as witnessed by the fact that such activities as opera singing, trumpet or didgeridoo instrument playing, have been used to successfully treat OSA. The investigators theorize that these activities (including WBV) entrain breathing and thus "condition" the apneustic center to improve airway dilation during sleep. Despite the promising preliminary data, the impact of WBV needs to be examined in a larger number of persons with OSA and the neural mechanisms of WBV on the apneustic regions of the lower pons remain to be explored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
whole body vibration, sleep, apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group will receive intervention and will be evaluated before and after intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole Body Vibration
Arm Type
Experimental
Arm Description
OSA subjects will be asked to use whole body vibration machine for 30 minutes, 3 times a week for 6 weeks in between visits.
Intervention Type
Device
Intervention Name(s)
Whole Body Vibration
Intervention Description
Whole Body Vibration Machine from the company Confidence Fitness
Primary Outcome Measure Information:
Title
Change from Baseline OSA Severity at 6 weeks
Description
OSA severity as measured by Apnea-Hypopnea Index (AHI)
Time Frame
Baseline and 6 weeks
Title
Change from Baseline Brain Structure at 6 weeks
Description
Brain structure as measured by brain magnetic resonance imaging
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline PSQI at 6 weeks
Description
Sleep quality as measured by Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Baseline and 6 weeks
Title
Change from Baseline Nonin Wristox Measurement at 6 Weeks
Description
Sleep quality as measured by Nonin Wristox2
Time Frame
Baseline and 6 weeks
Title
Change in Baseline Balance at 6 weeks
Description
Balance as measured by timing how long subject can balance on dominant foot (in seconds)
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary A Woo, PhD, RN
Organizational Affiliation
UCLA School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
300 Medical Plaza
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Investigators will share all de-identified (i.e., no personal identifiers or other HIPAA-related information) data
IPD Sharing Time Frame
Data will be made available 6 months after study completion
IPD Sharing 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)
Citations:
PubMed Identifier
23589584
Citation
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.
Results Reference
background
PubMed Identifier
25142557
Citation
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.
Results Reference
background
PubMed Identifier
22131602
Citation
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.
Results Reference
background
PubMed Identifier
18250209
Citation
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.
Results Reference
background
Links:
URL
http://www.sleepeducation.org/healthysleep
Description
National Healthy Sleep Awareness Project

Learn more about this trial

Whole Body Vibration for OSA

We'll reach out to this number within 24 hrs