Positional Obstructive Sleep ApneaNCT02553902
Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea
A study testing Sleep position trainer, Mandibular advancement device and Continuous positive airway pressure in people with Positional Obstructive Sleep Apnea, run by Onze Lieve Vrouwe Gasthuis at 2 sites in 2 countries.
Trial summary
OBJECTIVES: To evaluate the effect and cost-utility of a combination therapy of SPT+MAD compared with continuous positive airway pressure (CPAP) in patients with moderate positional obstructive sleep apnea (POSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Positional Obstructive Sleep Apnea
- What is being tested?
- Sleep position trainer, Mandibular advancement device and Continuous positive airway pressure
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Ability to speak, read and write Dutch
- Ability to follow up
- Diagnosis with symptomatic moderate OSA (15 < AHI < 30)
- Diagnosis of 10 to 90% supine position during the night
- AHI supine is 2 > as high as AHI non-supine
- Own a Windows PC and ability to install SPT connection software and upload research data
- Expected to maintain current lifestyle (sports, medicine, diet etc.)
Who cannot join
- Many dental problems; insufficient teeth for wearing MRA
- Medication used/ related to sleeping disorders
- Central Sleep Apnea 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 14Show fewer
- Seizure disorder
- Known medical history of mental retardation, memory disorders or psychiatric disorders
- 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 MRA, CPAP or SPT
- Pregnancy
Trial locations and contacts
2 sites in 2 countries.
Patty Vonk, MD contact
N de Vries, Professor contact
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital (UZA)
Antwerp
O.M. Vanderveken, Professor
Netherlands1 site, 1 recruiting
- Recruiting
OLVG West
Amsterdam
N. de Vries, Professor, n.vries@olvg.nl
Patty Vonk, MD, researchkno@olvg.nl
About this study
Official title: Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea Patients
OBJECTIVES:
To evaluate the effect and cost-utility of a combination therapy of SPT+MAD compared with continuous positive airway pressure (CPAP) in patients with moderate positional obstructive sleep apnea (POSA).
Read more
HYPOTHESIS:
The SPT+MAD combination is more cost-effective and effective, in means of reduction of the apnea-hypopnea index (AHI), quality of life and compliance, compared with CPAP.
STUDY DESIGN:
A multicenter randomized clinical trial (RCT) will be performed with a follow-up of 12 months per patient. Patients will be randomized for CPAP or the combination SPT and MRA. All outcomes will be measured at baseline, month 3, 6 and 12.
STUDY POPULATION:
Patients diagnosed with moderate POSA according to polysomnography (PSG) results.
INTERVENTION / STANDARD INTERVENTION TO BE COMPARED TO:
The SPT trains POSA patients to sleep in non-supine positions, CPAP uses positive airway pressure to open the airway; MRA is an intra-oral prosthesis, which holds the mandible in a protrusive position, all to prevent effectively apneic events.
OUTCOME MEASURES:
AHI, compliance, quality-adjusted life year (QALY), direct and indirect costs, cardiovascular parameters, incremental cost-effectiveness ratio (ICER)
SAMPLE SIZE / DATA ANALYSIS:
100 subjects in each treatment group, total of 200 patients.
COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS:
The SPT is expected to improve the cost-effectiveness of overall treatment of POSA patients, and will save annually approximately 35-150 million euros.
- Conditions
- Positional Obstructive Sleep Apnea
- Being tested
- Sleep position trainer, Mandibular advancement device, Continuous positive airway pressure
- Keywords
- Positional therapy, MAD, Oral appliance, Sleep position trainer, POSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep position trainerDevice
Mandibular advancement deviceDevice
Also called MRA, MAD
Continuous positive airway pressureDevice
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy | Active comparator | Sleep Position Trainer + Mandibular Advancement device combination The SPT is a sensor that measures the sleeping position, and gives the user feedback about wrong positions with a soft vibration. A user is then able to react to the signal and turn into a non-supine position. To stimulate compliance, information is provided about nightly behaviour, implicating a learning pattern by viewing the data on a home computer.
MRA or oral appliances (OA) works by advancing the mandible and its attached soft tissue structures forward they aim to increase upper airway size. Receives: Device: Sleep position trainer; Device: Mandibular advancement device |
| CPAPContinuous positive airway pressure | Active comparator | Continuous positive airway pressure (CPAP) functions as a pneumatic splint to maintain upper airway patency. Possible side effect can be related to the interface, pressure and negative social factors. Receives: Device: Continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index (AHI)
Measured: change from baseline, after 3, 6 and 12 months
Secondary outcomes (8)
Outcome of Quality of Life questionnaires
EQ-5D
Measured: change from baseline, after 3, 6 and 12 months
Outcome of Quality of Life questionnaires
Epworth Sleeping Scale (ESS)
Measured: change from baseline, after 3, 6 and 12 months
Outcome of Quality of Life questionnaires
Functional Outcome Sleep Questionnaire (FOSQ)
Measured: change from baseline, after 3, 6 and 12 months
(Societal) costs of treatment
iMTA Productivity Cost Questionnaire (iPCQ)
Measured: change from baseline, after 3, 6 and 12 months
(Societal) costs of treatment
iMTA Medical Consumption Questionnaire (iMCQ)
Measured: change from baseline, after 3, 6 and 12 months
Therapy compliance
Measurement of actual wearing time (in hours) per night
Measured: change from baseline, after 3, 6 and 12 months
Cardiovascular parameters
Systolic and diastolic blood pressure
Measured: change from baseline, after 3, 6 and 12 months
Cardiovascular parameters
Pulse rate
Measured: change from baseline, after 3, 6 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 posted18 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positional Obstructive Sleep ApneaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Principal investigator, L.B.L. Benoist, Onze Lieve Vrouwe Gasthuis
- Investigators
- O.M. Vanderveken, Professor, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553902
- Sponsor's protocol ID
- NL52032.029.15
- Status last verified
- Apr 2018
- First submitted
- 14 Sep 2015
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT02553902
- Acronym / sponsor ID
- NL52032.029.15
- Conditions
- Positional Obstructive Sleep Apnea
- Keywords
- Positional therapy, MAD, Oral appliance, Sleep position trainer, POSA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Onze Lieve Vrouwe GasthuisUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Sep 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.
OBJECTIVES:
To evaluate the effect and cost-utility of a combination therapy of SPT+MAD compared with continuous positive airway pressure (CPAP) in patients with moderate positional obstructive sleep apnea (POSA).
HYPOTHESIS:
The SPT+MAD combination is more cost-effective and effective, in means of reduction of the apnea-hypopnea index (AHI), quality of life and compliance, compared with CPAP.
STUDY DESIGN:
A multicenter randomized clinical trial (RCT) will be performed with a follow-up of 12 months per patient. Patients will be randomized for CPAP or the combination SPT and MRA. All outcomes will be measured at baseline, month 3, 6 and 12.
STUDY POPULATION:
Patients diagnosed with moderate POSA according to polysomnography (PSG) results.
INTERVENTION / STANDARD INTERVENTION TO BE COMPARED TO:
The SPT trains POSA patients to sleep in non-supine positions, CPAP uses positive airway pressure to open the airway; MRA is an intra-oral prosthesis, which holds the mandible in a protrusive position, all to prevent effectively apneic events.
OUTCOME MEASURES:
AHI, compliance, quality-adjusted life year (QALY), direct and indirect costs, cardiovascular parameters, incremental cost-effectiveness ratio (ICER)
SAMPLE SIZE / DATA ANALYSIS:
100 subjects in each treatment group, total of 200 patients.
COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS:
The SPT is expected to improve the cost-effectiveness of overall treatment of POSA patients, and will save annually approximately 35-150 million euros.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination therapy | Active comparator | Device: Sleep position trainer, Device: Mandibular advancement deviceSleep Position Trainer + Mandibular Advancement device combination The SPT is a sensor that measures the sleeping position, and gives the user feedback about wrong positions with a soft vibration. A user is then able to react to the signal and turn into a non-supine position. To stimulate compliance, information is provided about nightly behaviour, implicating a learning pattern by viewing the data on a home computer. MRA or oral appliances (OA) works by advancing the mandible and its attached soft tissue structures forward they aim to increase upper airway size. |
| CPAPContinuous positive airway pressure | Active comparator | Device: Continuous positive airway pressureContinuous positive airway pressure (CPAP) functions as a pneumatic splint to maintain upper airway patency. Possible side effect can be related to the interface, pressure and negative social factors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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
- Diagnosis with symptomatic moderate OSA (15 < AHI < 30)
- Diagnosis of 10 to 90% supine position during the night
Key exclusion criteria (14 listed)
- Many dental problems; insufficient teeth for wearing MRA
- Medication used/ related to sleeping disorders
- Central Sleep Apnea 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 trainer | Device | Combination therapy |
| Mandibular advancement deviceAlso: MRA, MAD | Device | Combination therapy |
| Continuous positive airway pressure | Device | CPAPContinuous positive airway pressure |
Primary outcome
Apnea-hypopnea index (AHI)
Time frame: change from baseline, after 3, 6 and 12 months
8 secondary outcomes
Outcome of Quality of Life questionnaires
Time frame: change from baseline, after 3, 6 and 12 months
Outcome of Quality of Life questionnaires
Time frame: change from baseline, after 3, 6 and 12 months
Outcome of Quality of Life questionnaires
Time frame: change from baseline, after 3, 6 and 12 months
(Societal) costs of treatment
Time frame: change from baseline, after 3, 6 and 12 months
(Societal) costs of treatment
Time frame: change from baseline, after 3, 6 and 12 months
Therapy compliance
Time frame: change from baseline, after 3, 6 and 12 months
Cardiovascular parameters
Time frame: change from baseline, after 3, 6 and 12 months
Cardiovascular parameters
Time frame: change from baseline, after 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Positional Obstructive Sleep Apnea
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Recruiting
Effectiveness of Audio Cues to Achieve Positional Therapy in Patients With Positional Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA), Positional 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.
Patty Vonk, MD contact
N de Vries, Professor contact
O.M. Vanderveken, Professor principal investigator
University Hospital, Antwerp
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep position trainer, Mandibular advancement device and Continuous positive airway pressure in people with Positional Obstructive Sleep Apnea, run by Onze Lieve Vrouwe Gasthuis at 2 sites in 2 countries.
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 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: status not confirmed, as of the sponsor's last update on 11 Apr 2018. 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 Belgium, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patty Vonk, MD (researchkno@olvg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea index (AHI) (time frame: change from baseline, after 3, 6 and 12 months). 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 11 Apr 2018.