Obstructive Sleep ApneaNCT04009486
Whole Body Vibration and the Brain in OSA
A study testing Whole Body Vibration in people with Obstructive Sleep Apnea, run by University of California, Los Angeles.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 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
- No sites listed yet
- Study dates
- Apr 2020to Mar 2022
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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)
About this study
Official title: Impact of Whole Body Vibration on Sleep Symptoms and the Brain in Obstructive Sleep Apnea
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.
Read the detailed 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Whole Body Vibration
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body VibrationDevice
Subjects will undergo whole body vibration (standing on a "power plate" device 3 times a week, for 30 minute sessions, for 6 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Sleep Apnea | Experimental | Subjects will undergo 6 weeks of whole body vibration. Receives: Device: Whole Body Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after 6 weeks of whole body vibration use
Secondary outcomes (2)
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)
Measured: after 6 weeks of whole body vibration use
Brain Structure
high resolution T1 or T2 (diffusion tensor imaging) examination of brain structure changes (baseline and after 6 weeks)
Measured: after 6 weeks of whole body vibration use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startApr 2020 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: Not approved for funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 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
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009486
- Sponsor's protocol ID
- 19-006112
- Status last verified
- Nov 2020
- First submitted
- 2 Jul 2019
- Last updated
- 19 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Whole Body Vibration on Sleep Symptoms and the Brain in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04009486
- Acronym / sponsor ID
- 19-006112
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not approved for funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 5 Jul 2019 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea | Experimental | Device: Whole Body VibrationSubjects will undergo 6 weeks of whole body vibration. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 VibrationSubjects will undergo whole body vibration (standing on a "power plate" device 3 times a week, for 30 minute sessions, for 6 weeks) | Device | Obstructive Sleep Apnea |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: after 6 weeks of whole body vibration use
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
2 secondary outcomes
Sleep Symptoms
Time frame: after 6 weeks of whole body vibration use
Brain Structure
Time frame: after 6 weeks of whole body vibration use
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 19 Nov 2020.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
The record lists no contact. Use the official record to reach the sponsor.
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.
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 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Apnea-Hypopnea Index (AHI) (time frame: after 6 weeks of whole body vibration use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2020.