Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT02553902|
Recruitment Status : Recruiting
First Posted : September 18, 2015
Last Update Posted : April 11, 2018
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).
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.
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Positional Obstructive Sleep Apnea||Device: Sleep position trainer Device: Mandibular advancement device Device: Continuous positive airway pressure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea Patients|
|Actual Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Combination therapy
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.
Device: Sleep position trainer
Device: Mandibular advancement device
Other Name: MRA, MAD
Active Comparator: CPAPContinuous positive airway pressure
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.
Device: Continuous positive airway pressure
- Apnea-hypopnea index (AHI) [ 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 ]EQ-5D
- Outcome of Quality of Life questionnaires [ Time Frame: change from baseline, after 3, 6 and 12 months ]Epworth Sleeping Scale (ESS)
- Outcome of Quality of Life questionnaires [ Time Frame: change from baseline, after 3, 6 and 12 months ]Functional Outcome Sleep Questionnaire (FOSQ)
- (Societal) costs of treatment [ Time Frame: change from baseline, after 3, 6 and 12 months ]iMTA Productivity Cost Questionnaire (iPCQ)
- (Societal) costs of treatment [ Time Frame: change from baseline, after 3, 6 and 12 months ]iMTA Medical Consumption Questionnaire (iMCQ)
- Therapy compliance [ Time Frame: change from baseline, after 3, 6 and 12 months ]Measurement of actual wearing time (in hours) per night
- Cardiovascular parameters [ Time Frame: change from baseline, after 3, 6 and 12 months ]Systolic and diastolic blood pressure
- Cardiovascular parameters [ Time Frame: change from baseline, after 3, 6 and 12 months ]Pulse rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553902
|Antwerp University Hospital (UZA)||Recruiting|
|Contact: O.M. Vanderveken, Professor|
|Contact: N. de Vries, Professor email@example.com|
|Contact: Patty Vonk, MD firstname.lastname@example.org|
|Principal Investigator:||O.M. Vanderveken, Professor||University Hospital, Antwerp|