Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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.

Official Title
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Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea Patients

Conditions
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Positional Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Sleep position trainer
* Device: Mandibular advancement device
* Device: Continuous positive airway pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.) Exclusion Criteria: 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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Combination therapy<br>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<br> <br> Device: Mandibular advancement device<br> <br> * Other names: MRA, MAD;|
| Active Comparator: CPAPContinuous positive airway pressure<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-hypopnea index (AHI) |  | change from baseline, after 3, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of Quality of Life questionnaires | EQ-5D | change from baseline, after 3, 6 and 12 months | 
| Outcome of Quality of Life questionnaires | Epworth Sleeping Scale (ESS) | change from baseline, after 3, 6 and 12 months | 
| Outcome of Quality of Life questionnaires | Functional Outcome Sleep Questionnaire (FOSQ) | change from baseline, after 3, 6 and 12 months | 
| (Societal) costs of treatment | iMTA Productivity Cost Questionnaire (iPCQ) | change from baseline, after 3, 6 and 12 months | 
| (Societal) costs of treatment | iMTA Medical Consumption Questionnaire (iMCQ) | change from baseline, after 3, 6 and 12 months | 
| Therapy compliance | Measurement of actual wearing time (in hours) per night | change from baseline, after 3, 6 and 12 months | 
| Cardiovascular parameters | Systolic and diastolic blood pressure | change from baseline, after 3, 6 and 12 months | 
| Cardiovascular parameters | Pulse rate | change from baseline, after 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positional therapy, MAD, Oral appliance, Sleep position trainer, POSA