Obstructive Sleep ApneaPOSANCT02045576
RCT: Oral Appliance Therapy and Sleep Position Trainer in Patients With Position Dependant Obstructive Sleep Apnea
A study testing sleep position trainer and Oral Appliance Therapy in people with Obstructive Sleep Apnea and Sleep Position Trainer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial summary
SUMMARY Rationale: Fifty-six percent of patients with Obstructive Sleep Apnea (OSA) are position dependent, defined as having an AHI, which is at least twice as high in supine sleeping position compared to the AHI during sleep in other positions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep Position Trainer, Oral Appliance Therapy
- What is being tested?
- sleep position trainer and Oral Appliance Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jun 2013to Jul 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older.
- Ability to speak, read and write Dutch.
- Ability to follow up.
- Ability to use a computer with internet connection and windows-software for uploading data and online questionnaires.
- Diagnosis with symptomatic mild or moderate OSA (5 < AHI < 30).
- Diagnosis of 10 to 90% supine position during the night.
- AHI supine is >2 times as high as AHI non-supine.
- Expected to maintain current lifestyle (sports, medicine, diet etc.).
Who cannot join
- Many dental problems; insufficient teeth for wearing OAT.
- Medication used/ related to sleeping disorders.
- Central Sleep Apnoea Syndrome.
- Night or shifting work.
- Severe chronic heart failure.
- Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy).
Show all 15Show fewer
- Seizure disorder.
- Known medical history of mental retardation, memory disorders or psychiatric disorders.
- Patients with old type of pacemakers (It is possible that old types of peacemakers are not compatible with the electromagnetic radiation of the electronics of the SPT).
- Shoulder, neck and back complaints.
- Reversible morphological upper airway abnormalities (e.g. enlarged tonsils).
- Inability to provide informed consent.
- Simultaneous use of other treatment modalities to treat OSA.
- Previous treatment for OSA with OAT or SPT
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Academic Medical Center
Amsterdam
St Lucas Andreas Hospital
Amsterdam
About this study
Official title: Positional Therapy With the Sleep Position Trainer Versus Oral Appliance Therapy in Patients With Position Dependent Obstructive Sleep Apnea; A Randomised Controlled Trial
SUMMARY Rationale: Fifty-six percent of patients with Obstructive Sleep Apnea (OSA) are position dependent, defined as having an AHI, which is at least twice as high in supine sleeping position compared to the AHI during sleep in other positions. Standard therapy for patients having mild or moderate POSA is treatment with an Oral Appliance Trainer (OAT). Recently a new device Sleep Position Trainer (SPT) is been introduced especially for patients with POSA.
Objective: To compare the effect of positional therapy with the SPT versus OAT on polysomnographic (PSG) parameters, to evaluate the compliance and measuring the possible learning effect that might occur with POSA patients using the SPT for positional therapy over a long term.
Read more
Study design: Randomised controlled trial Study population: The participants of the research will be recruited from the departments of Otolaryngology and Clinical Neurophysiology, Saint Lucas Andreas Hospital, Amsterdam, the Netherlands.
Participants will be males or females older than 18 years with diagnosis of positional OSA.
Intervention: The SPT is a sensor positioned in an elastic band attached around the body. The SPT measures the body position and vibrates when the patient lies in supine position. Oral appliance therapy (OAT) is an intra-oral prosthesis, which holds the mandible in a protrusive position. Because of this position more pharyngeal space will be available and the AHI will decrease. After randomisation the first group (n=45) will sleep for a period of 90 +/- 2 days with the SPT every night. The second group (n=45) will also sleep for a period of 90 +/- 2 days only with OAT. After this period the PSG is repeated. Long- term outcome in AHI is measured by repeating the PSG after 1 year. Main study parameters/ endpoints: Primary endpoints; reduction of PSG parameters, in particular AHI, AI, HI, DI, reduction of % of sleeping supine sleep position, without disturbance of the sleep quality.
Secondary endpoints: Outcome of Quality of Life questionnaires; EQ-5D, ESS, FOSQ and MFIQ.
Compliance and learning effect will also be evaluated for the time period of 3 and 12 months. Finally cardiovascular parameters like blood pressure, pulse rate and BMI/neck circumference will be assessed.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks for patients participating in this study are negligible. Inconveniences of the SPT can be discomfort caused by irritation of the band, difficulties with an increased sleeping period on the side or difficulties sleeping with the SPT. This can be compensated by the expected improvement of sleep quality caused by the therapy. Possible side effects of OAT may be discomfort in the jaw, sensitivity of the teeth and a dry mouth. Withdrawing from this therapy means immediate relief of inconveniences.
- Being tested
- sleep position trainer, Oral Appliance Therapy
- Keywords
- Obstructive Sleep Apnea, sleep position trainer, oral appliance therapy, mandibular advancement device or splint
- 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.
sleep position trainerDevice
Also called Nightbalance
Oral Appliance TherapyDevice
Also called Somnodent
| Study group | Role | What they receive |
|---|---|---|
| Sleep position trainer | Experimental | Nightbalance Receives: Device: sleep position trainer |
| Oral Appliance Therapy | Active comparator | Somnodent Receives: Device: Oral Appliance Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in reducing the mean AHI
Apnoea Hypopnoea Index (AHI)
Measured: 12 months
Secondary outcomes (4)
effectiveness in quality of life
Outcomes in QoL- questionnaires:
EQ-5D, Epworth Sleeping Scale (ESS), Functional Outcome Sleep Questionnaire (FOSQ), Mandibular Function Impairment Questionnaire (MFIQ).
Measured: 3, 6, 9 and 12 months
Compliance
Actual wearing time in minutes per night
Measured: 3, 6, 9, 12 months
Cardiovascular parameters
Blood pressure
Measured: 3, 6, 9, 12 months
Cardiovascular parameters
Pulse
Measured: 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- St. Lucas Andreas Ziekenhuis Hospital
- Responsible party
- Principal investigator, M.H.T. de Ruiter, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045576
- Sponsor's protocol ID
- POSA
- Acronym
- POSA
- Status last verified
- Jul 2016
- First submitted
- 26 Nov 2013
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Ruiter MHT, Benoist LBL, de Vries N, de Lange J. Durability of treatment effects of the Sleep Position Trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial. Sleep Breath. 2018 May;22(2):441-450. doi: 10.1007/s11325-017-1568-4. Epub 2017 Sep 15.
PubMed 28913630Benoist L, de Ruiter M, de Lange J, de Vries N. A randomized, controlled trial of positional therapy versus oral appliance therapy for position-dependent sleep apnea. Sleep Med. 2017 Jun;34:109-117. doi: 10.1016/j.sleep.2017.01.024. Epub 2017 Mar 27.
PubMed 28522078
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positional Therapy With the Sleep Position Trainer Versus Oral Appliance Therapy in Patients With Position Dependent Obstructive Sleep Apnea; A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02045576
- Acronym / sponsor ID
- POSA / POSA
- Keywords
- Obstructive Sleep Apnea, sleep position trainer, oral appliance therapy, mandibular advancement device or splint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- St. Lucas Andreas Ziekenhuis Hospital
- Study start
- Jun 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 27 Jan 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.
SUMMARY Rationale: Fifty-six percent of patients with Obstructive Sleep Apnea (OSA) are position dependent, defined as having an AHI, which is at least twice as high in supine sleeping position compared to the AHI during sleep in other positions. Standard therapy for patients having mild or moderate POSA is treatment with an Oral Appliance Trainer (OAT). Recently a new device Sleep Position Trainer (SPT) is been introduced especially for patients with POSA.
Objective: To compare the effect of positional therapy with the SPT versus OAT on polysomnographic (PSG) parameters, to evaluate the compliance and measuring the possible learning effect that might occur with POSA patients using the SPT for positional therapy over a long term.
Study design: Randomised controlled trial Study population: The participants of the research will be recruited from the departments of Otolaryngology and Clinical Neurophysiology, Saint Lucas Andreas Hospital, Amsterdam, the Netherlands.
Participants will be males or females older than 18 years with diagnosis of positional OSA.
Intervention: The SPT is a sensor positioned in an elastic band attached around the body. The SPT measures the body position and vibrates when the patient lies in supine position. Oral appliance therapy (OAT) is an intra-oral prosthesis, which holds the mandible in a protrusive position. Because of this position more pharyngeal space will be available and the AHI will decrease. After randomisation the first group (n=45) will sleep for a period of 90 +/- 2 days with the SPT every night. The second group (n=45) will also sleep for a period of 90 +/- 2 days only with OAT. After this period the PSG is repeated. Long- term outcome in AHI is measured by repeating the PSG after 1 year. Main study parameters/ endpoints: Primary endpoints; reduction of PSG parameters, in particular AHI, AI, HI, DI, reduction of % of sleeping supine sleep position, without disturbance of the sleep quality.
Secondary endpoints: Outcome of Quality of Life questionnaires; EQ-5D, ESS, FOSQ and MFIQ.
Compliance and learning effect will also be evaluated for the time period of 3 and 12 months. Finally cardiovascular parameters like blood pressure, pulse rate and BMI/neck circumference will be assessed.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks for patients participating in this study are negligible. Inconveniences of the SPT can be discomfort caused by irritation of the band, difficulties with an increased sleeping period on the side or difficulties sleeping with the SPT. This can be compensated by the expected improvement of sleep quality caused by the therapy. Possible side effects of OAT may be discomfort in the jaw, sensitivity of the teeth and a dry mouth. Withdrawing from this therapy means immediate relief of inconveniences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep position trainer | Experimental | Device: sleep position trainerNightbalance |
| Oral Appliance Therapy | Active comparator | Device: Oral Appliance TherapySomnodent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years and older.
- Ability to speak, read and write Dutch.
- Ability to follow up.
- Ability to use a computer with internet connection and windows-software for uploading data and online questionnaires.
- Diagnosis with symptomatic mild or moderate OSA (5 < AHI < 30).
Key exclusion criteria (15 listed)
- Many dental problems; insufficient teeth for wearing OAT.
- Medication used/ related to sleeping disorders.
- Central Sleep Apnoea Syndrome.
- Night or shifting work.
- Severe chronic heart failure.
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 |
|---|---|---|
| sleep position trainerAlso: Nightbalance | Device | Sleep position trainer |
| Oral Appliance TherapyAlso: Somnodent | Device | Oral Appliance Therapy |
Primary outcome
Efficacy in reducing the mean AHI
Time frame: 12 months
Apnoea Hypopnoea Index (AHI)
4 secondary outcomes
effectiveness in quality of life
Time frame: 3, 6, 9 and 12 months
Compliance
Time frame: 3, 6, 9, 12 months
Cardiovascular parameters
Time frame: 3, 6, 9, 12 months
Cardiovascular parameters
Time frame: 3, 6, 9 and 12 months
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 12 Jul 2016.
- Derived from this study: PubMed 28913630de Ruiter MHT, Benoist LBL, de Vries N, de Lange J. Durability of treatment effects of the Sleep Position Trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial. Sleep Breath. 2018 May;22(2):441-450. doi: 10.1007/s11325-017-1568-4. Epub 2017 Sep 15.
- Derived from this study: PubMed 28522078Benoist L, de Ruiter M, de Lange J, de Vries N. A randomized, controlled trial of positional therapy versus oral appliance therapy for position-dependent sleep apnea. Sleep Med. 2017 Jun;34:109-117. doi: 10.1016/j.sleep.2017.01.024. Epub 2017 Mar 27.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep position trainer and Oral Appliance Therapy in people with Obstructive Sleep Apnea and Sleep Position Trainer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
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 8 inclusion and 15 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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Efficacy in reducing the mean AHI (time frame: 12 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 NCT02045576, which also lists 2 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 12 Jul 2016.