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| Name | Class |
|---|---|
| University Hospital, Antwerp | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep position trainer | Device |
| ||
| Mandibular advancement device |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea index (AHI) | change from baseline, after 3, 6 and 12 months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patty Vonk, MD | Contact | researchkno@olvg.nl | ||
| N de Vries, Professor | Contact | n.vries@slaz.nl |
| Name | Affiliation | Role |
|---|---|---|
| O.M. Vanderveken, Professor | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital (UZA) | Recruiting | Antwerp | Belgium |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| D018810 | Magnetic Resonance Angiography |
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Device |
|
|
| Continuous positive airway pressure | Device |
|
| 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 |
| OLVG West | Recruiting | Amsterdam | Netherlands |
|
| D008279 |
| Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000792 | Angiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |