Positional Obstructive Sleep Apnea Clinical Trial
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).
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04425408 -
Comparison of 2 Different Positional Therapies for Positional Obstructive Sleep Apnea Syndrome
|
N/A |