Obstructive Sleep Apnea (OSAS)Phase 2/3POSASNCT02114424
Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS)
A Phase 2/3 study testing Positional vibrator belt in people with Obstructive Sleep Apnea (OSAS), run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
POSAS can be treated with CPAP however there is now evidence from a few studies that Night Balance is effective in POSAS. Night Balance seems to be better accepted than CPAP so we would like to examine if we could find similar results in routine clinical work and especially we would like to confirm the subjective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSAS)
- What is being tested?
- Positional vibrator belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Feb 2016
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHI supine ≥ AHI non-supine x 2,
- AHI supine ≥ 10
- AHI non-supine <10
- 10 -90 % sleep time in supine position
- Daytime tiredness and/or disturbed sleep and/or snoring
Who cannot join
- Not able or willing to cooperate
- Age <18 years
- Central Sleep Apnea
- Night or shifting work
- Severe chronic heart failure or severe COPD
- A medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy)
Show all 16Show fewer
- Seizure disorder
- A known medical history of mental retardation, memory disorders or psychiatric disorders
- The inability to provide informed consent
- Pacemaker
- Pain in joints or shoulder
- Other reasons unable to sleep in lateral positions.
- Pregnant females or females that plan pregnancy in study period (problems sleeping supine)
- Breastfeeding females in study period (other reasons for disturbed sleep)
- Plan weight reduction in study period
- Plan to quit smoking in study period
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Glostrup University Hospital
Glostrup Municipality, 2600
Philip Toennesen, M.D., Ph.D.
About this study
Official title: Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS) A Prospective, Randomized, Controlled Open Trial in Daily Clinical Practice
POSAS can be treated with CPAP however there is now evidence from a few studies that Night Balance is effective in POSAS. Night Balance seems to be better accepted than CPAP so we would like to examine if we could find similar results in routine clinical work and especially we would like to confirm the subjective effects with objective measures i.e. a reduction in AHI in the supine position during sleep.
Read the detailed description
Primary aim: Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine).
Secondary aim: Efficacy and adherence of Night Balance in POSAS after a 6 months period (Sleep supine and compliance and AHI).
Nigh Balance is a vibrator and a belt that vibrate when laying supine so that after a few days you will not sleep supine.
- Conditions
- Obstructive Sleep Apnea (OSAS)
- Being tested
- Positional vibrator belt
- Keywords
- Positional Obstructive sleep apnea syndrome (POSAS), Obstructive sleep apnea syndrome (OSAS), Apnea-Hypnea Index (AHI), Sleep questionnaire, Positional sleep apnea belt, Adverse events, Compliance
- Medical subject headings
- Sleep Apnea, Obstructive, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positional vibrator beltDevice
Also called Night Balance, B.V,, 2629 JD Delft, The Netherlands
Belt with vibarator to avoid sleep supine
| Study group | Role | What they receive |
|---|---|---|
| Positional vibrator belt | Active comparator | Positional belt to avoid supine sleep. Receives: Device: Positional vibrator belt |
| No Night balance | No intervention | the first 2 months without Night Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine and AHI).
AFter 2 months assessment will be done by sleep questionnaires and CRM
Measured: After 2 months
Secondary outcomes (1)
Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine).
ALl wil ahve a new CRM after 6 months with Night Balance and sleep questionnaires
Measured: 6 months after entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea (OSAS)Studies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Tønnesen, M.D., Glostrup University Hospital, Copenhagen
- Investigators
- Philip Toennesen, M.D., Ph.D., Principal investigator, GlsotrupUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114424
- Sponsor's protocol ID
- H-3-2014-039
- Acronym
- POSAS
- Status last verified
- Apr 2014
- First submitted
- 10 Apr 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
23. van der Star A, Mekking S, van Riet M. The technical validation of the Sleep Position Trainer. Nightbalance Research and Development [Internet]. 2012 Oct [cited 2013 Dec 6]:1-12. Available from http://www.nightbalance.com/research.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS) A Prospective, Randomized, Controlled Open Trial in Daily Clinical Practice
- ClinicalTrials.gov ID
- NCT02114424
- Acronym / sponsor ID
- POSAS / H-3-2014-039
- Conditions
- Obstructive Sleep Apnea (OSAS)
- Keywords
- Positional Obstructive sleep apnea syndrome (POSAS), Obstructive sleep apnea syndrome (OSAS), Apnea-Hypnea Index (AHI), Sleep questionnaire, Positional sleep apnea belt, Adverse events, Compliance
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 15 Apr 2014 (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.
POSAS can be treated with CPAP however there is now evidence from a few studies that Night Balance is effective in POSAS. Night Balance seems to be better accepted than CPAP so we would like to examine if we could find similar results in routine clinical work and especially we would like to confirm the subjective effects with objective measures i.e. a reduction in AHI in the supine position during sleep.
Detailed description
Primary aim: Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine).
Secondary aim: Efficacy and adherence of Night Balance in POSAS after a 6 months period (Sleep supine and compliance and AHI).
Nigh Balance is a vibrator and a belt that vibrate when laying supine so that after a few days you will not sleep supine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positional vibrator belt | Active comparator | Device: Positional vibrator beltPositional belt to avoid supine sleep. |
| No Night balance | No intervention | –the first 2 months without Night Balance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- AHI supine ≥ AHI non-supine x 2,
- AHI supine ≥ 10
- AHI non-supine <10
- 10 -90 % sleep time in supine position
- Daytime tiredness and/or disturbed sleep and/or snoring
Key exclusion criteria (16 listed)
- Not able or willing to cooperate
- Age <18 years
- Central Sleep Apnea
- Night or shifting work
- Severe chronic heart failure or severe COPD
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 |
|---|---|---|
| Positional vibrator beltAlso: Night Balance, B.V,, 2629 JD Delft, The NetherlandsBelt with vibarator to avoid sleep supine | Device | Positional vibrator belt |
Primary outcome
Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine and AHI).
Time frame: After 2 months
AFter 2 months assessment will be done by sleep questionnaires and CRM
1 secondary outcome
Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine).
Time frame: 6 months after entry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Background23. van der Star A, Mekking S, van Riet M. The technical validation of the Sleep Position Trainer. Nightbalance Research and Development [Internet]. 2012 Oct [cited 2013 Dec 6]:1-12. Available from http://www.nightbalance.com/research.
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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.
Philip Toennesen, M.D., Ph.D. principal investigator
GlsotrupUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Positional vibrator belt in people with Obstructive Sleep Apnea (OSAS), run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 15 Apr 2014. 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 Denmark. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Toennesen, M.D., Ph.D. ((45)51264850, philip.toennesen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine and AHI). (time frame: After 2 months). 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 NCT02114424, which also lists 1 linked publication.
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 15 Apr 2014; AzTrials last refreshed its copy on 6 Nov 2026.