OSANCT02613975
A Cross Over Case Control Study of a Vibration Positional Device for Treatment of OSA
A study testing positonal device in people with OSA, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Positional therapy is considered as a kind of conservative treatment especially for patients with OSA which varies with body positions, and has been reported to be useful in selected cases especially those with positional OSA. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- OSA
- What is being tested?
- positonal device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- Apr 2015to Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with position dependent OSA which is defined as supine AHI >2 times the AHI in other positions, while an overall AHI >5/hr.
- Patients who cannot tolerate/not using CPAP.
- Patients who are on dental devices but residual AHI is > 15 and symptomatic.
- Patients consent to study and able to follow the instruction of using positional device and home sleep study device.
Who cannot join
- Patients with pregnancy.
- Patients who refuse home sleep studies.
- Patients with parasomnias.
- Patients who cannot follow the instruction of using positional device or home sleep study device.
- Patients who tolerate CPAP well with good treatment outcome.
- Patients on dental device with good symptoms improvement and residual AHI < 15/hr
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
Shatin
About this study
Official title: A Cross Over Case Control Study Using a Vibration Positional Device for Treatment of Position Dependent Obstructive Sleep Apnea
Positional therapy is considered as a kind of conservative treatment especially for patients with OSA which varies with body positions, and has been reported to be useful in selected cases especially those with positional OSA. Positional OSA is present when the overall apnea hyponea index (AHI) is > 5/hr with a supine AHI being more than 2 times of AHI in other positions, in a symptomatic patient. There will be 2 groups of patients in this study. Group 1 consists of patients with positional OSA who refuse CPAP or tolerate CPAP poorly. They will be provided with a vibration device as treatment, which will be worn on the neck during sleep. This device senses the position of the patient during sleep. It will vibrate when the patient lies supine until the patient turns laterally, thus prevents the patient to lie flat during sleep and reduce the severity of OSA. It will be switched on and off for a period of 15 days alternatively with sleep study performed at the end of each period respectively to determine its efficacy in the on and off mode. There will be a wash out period of 1 week in between the on and off period to remove any residual effect. Group 2 consists of patients with positional OSA who are using dental device but response or tolerated poorly. They will use the vibration device with dental device together as dual therapy, to assess the role of combination therapy. The device will be operated in on and off mode with sleep study being performed in a similar manner as in group 1. Informed consent will be signed. Each participant will have 2 sleep studies performed at home, which will be supported technically by technician visiting their home for hook up of necessary equipment.
- Conditions
- OSA
- Being tested
- positonal device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positonal deviceDevice
positional device detects prone positional and will vibrate to cause patient to lie laterally
| Study group | Role | What they receive |
|---|---|---|
| on positional device | Experimental | patients who could not tolerate cpap will be provided with positional device for treatment of OSA which will vibrate when patients lie in prone position Receives: Device: positonal device |
| patients on dental device | Experimental | patients on dental devices but not optimally treated for OSA will be provided positional device for optimization of treatment for OSA, which will vibrate when patients lie in prone position Receives: Device: positonal device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of AHI using the positional device
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, To Kin Wang, Chinese University of Hong Kong
- Investigators
- Kin Wang To, MBChB, Principal investigator, Honoary clinical assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613975
- Sponsor's protocol ID
- CREC 2013.689
- Status last verified
- Jan 2020
- First submitted
- 23 Nov 2015
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Over Case Control Study Using a Vibration Positional Device for Treatment of Position Dependent Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02613975
- Acronym / sponsor ID
- CREC 2013.689
- Conditions
- OSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 25 Nov 2015 (estimated)
- 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.
Positional therapy is considered as a kind of conservative treatment especially for patients with OSA which varies with body positions, and has been reported to be useful in selected cases especially those with positional OSA. Positional OSA is present when the overall apnea hyponea index (AHI) is > 5/hr with a supine AHI being more than 2 times of AHI in other positions, in a symptomatic patient. There will be 2 groups of patients in this study. Group 1 consists of patients with positional OSA who refuse CPAP or tolerate CPAP poorly. They will be provided with a vibration device as treatment, which will be worn on the neck during sleep. This device senses the position of the patient during sleep. It will vibrate when the patient lies supine until the patient turns laterally, thus prevents the patient to lie flat during sleep and reduce the severity of OSA. It will be switched on and off for a period of 15 days alternatively with sleep study performed at the end of each period respectively to determine its efficacy in the on and off mode. There will be a wash out period of 1 week in between the on and off period to remove any residual effect. Group 2 consists of patients with positional OSA who are using dental device but response or tolerated poorly. They will use the vibration device with dental device together as dual therapy, to assess the role of combination therapy. The device will be operated in on and off mode with sleep study being performed in a similar manner as in group 1. Informed consent will be signed. Each participant will have 2 sleep studies performed at home, which will be supported technically by technician visiting their home for hook up of necessary equipment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| on positional device | Experimental | Device: positonal devicepatients who could not tolerate cpap will be provided with positional device for treatment of OSA which will vibrate when patients lie in prone position |
| patients on dental device | Experimental | Device: positonal devicepatients on dental devices but not optimally treated for OSA will be provided positional device for optimization of treatment for OSA, which will vibrate when patients lie in prone position |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with position dependent OSA which is defined as supine AHI >2 times the AHI in other positions, while an overall AHI >5/hr.
- Patients who cannot tolerate/not using CPAP.
- Patients who are on dental devices but residual AHI is > 15 and symptomatic.
- Patients consent to study and able to follow the instruction of using positional device and home sleep study device.
Key exclusion criteria (6 listed)
- Patients with pregnancy.
- Patients who refuse home sleep studies.
- Patients with parasomnias.
- Patients who cannot follow the instruction of using positional device or home sleep study device.
- Patients who tolerate CPAP well with good treatment outcome.
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 |
|---|---|---|
| positonal devicepositional device detects prone positional and will vibrate to cause patient to lie laterally | Device | on positional device, patients on dental device |
Primary outcome
Reduction of AHI using the positional device
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
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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.
Kin Wang To, MBChB principal investigator
Honoary clinical assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positonal device in people with OSA, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 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: finished, as of the sponsor's last update on 23 Jan 2020. 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 Hong Kong. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of AHI using the positional device (time frame: 1 year). 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 23 Jan 2020.