Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea
- Conditions
- Positional Obstructive Sleep Apnea
- Registration Number
- NCT02553902
- Lead Sponsor
- Onze Lieve Vrouwe Gasthuis
- Brief 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).
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Apnea-hypopnea index (AHI) change from baseline, after 3, 6 and 12 months
- Secondary Outcome Measures
Name Time Method (Societal) costs of treatment change from baseline, after 3, 6 and 12 months iMTA Medical Consumption Questionnaire (iMCQ)
Outcome of Quality of Life questionnaires change from baseline, after 3, 6 and 12 months Functional Outcome Sleep Questionnaire (FOSQ)
Therapy compliance change from baseline, after 3, 6 and 12 months Measurement of actual wearing time (in hours) per night
Cardiovascular parameters change from baseline, after 3, 6 and 12 months Pulse rate
Trial Locations
- Locations (2)
Antwerp University Hospital (UZA)
🇧🇪Antwerp, Belgium
OLVG West
🇳🇱Amsterdam, Netherlands
Antwerp University Hospital (UZA)🇧🇪Antwerp, BelgiumO.M. Vanderveken, ProfessorContact