Obstructive Sleep ApneaNCT03377621
Whole Body Vibration for OSA
A study testing Whole Body Vibration in people with Obstructive Sleep Apnea, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Whole Body Vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2017to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Whole Body Vibration for Obstructive Sleep Apnea
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Whole Body Vibration
- Keywords
- whole body vibration, sleep, apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body VibrationDevice
Whole Body Vibration Machine from the company Confidence Fitness
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Whole Body Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline OSA Severity at 6 weeks
OSA severity as measured by Apnea-Hypopnea Index (AHI)
Measured: Baseline and 6 weeks
Change from Baseline Brain Structure at 6 weeks
Brain structure as measured by brain magnetic resonance imaging
Measured: Baseline and 6 weeks
Secondary outcomes (3)
Change from Baseline PSQI at 6 weeks
Sleep quality as measured by Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline and 6 weeks
Change from Baseline Nonin Wristox Measurement at 6 Weeks
Sleep quality as measured by Nonin Wristox2
Measured: Baseline and 6 weeks
Change in Baseline Balance at 6 weeks
Balance as measured by timing how long subject can balance on dominant foot (in seconds)
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start2 Dec 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Why it stopped: Study was not funded, and therefore not conducted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group will receive intervention and will be evaluated before and after intervention.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary A. Woo, University of California, Los Angeles
- Investigators
- Mary A Woo, PhD, RN, Principal investigator, UCLA School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377621
- Sponsor's protocol ID
- 17-001323
- Status last verified
- Sep 2019
- First submitted
- 6 Dec 2017
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Investigators will share all de-identified (i.e., no personal identifiers or other HIPAA-related information) data
Publications
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.
PubMed 23589584Castronovo 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.
PubMed 25142557Billings 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.
PubMed 22131602Weaver 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.
PubMed 18250209
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Vibration for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03377621
- Acronym / sponsor ID
- 17-001323
- Conditions
- Obstructive Sleep Apnea
- Keywords
- whole body vibration, sleep, apnea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not funded, and therefore not conducted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 2 Dec 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group will receive intervention and will be evaluated before and after intervention.
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration | Experimental | Device: Whole Body VibrationOSA subjects will be asked to use whole body vibration machine for 30 minutes, 3 times a week for 6 weeks in between visits. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Body VibrationWhole Body Vibration Machine from the company Confidence Fitness | Device | Whole Body Vibration |
Primary outcome
Change from Baseline OSA Severity at 6 weeks
Time frame: Baseline and 6 weeks
OSA severity as measured by Apnea-Hypopnea Index (AHI)
Change from Baseline Brain Structure at 6 weeks
Time frame: Baseline and 6 weeks
Brain structure as measured by brain magnetic resonance imaging
3 secondary outcomes
Change from Baseline PSQI at 6 weeks
Time frame: Baseline and 6 weeks
Change from Baseline Nonin Wristox Measurement at 6 Weeks
Time frame: Baseline and 6 weeks
Change in Baseline Balance at 6 weeks
Time frame: Baseline and 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Background: PubMed 23589584Peppard 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.
- Background: PubMed 25142557Castronovo 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.
- Background: PubMed 22131602Billings 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.
- Background: PubMed 18250209Weaver 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.
- National Healthy Sleep Awareness ProjectLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Investigators will share all de-identified (i.e., no personal identifiers or other HIPAA-related information) data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary A Woo, PhD, RN principal investigator
UCLA School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Body Vibration in people with Obstructive Sleep Apnea, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline OSA Severity at 6 weeks (time frame: Baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377621, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.