Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Positional Obstructive Sleep Apnea
- Sponsor
- Onze Lieve Vrouwe Gasthuis
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Apnea-hypopnea index (AHI)
- Last Updated
- 8 years ago
Overview
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.
Investigators
L.B.L. Benoist
Drs.
Onze Lieve Vrouwe Gasthuis
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Apnea-hypopnea index (AHI)
Time Frame: change from baseline, after 3, 6 and 12 months
Secondary Outcomes
- (Societal) costs of treatment(change from baseline, after 3, 6 and 12 months)
- Outcome of Quality of Life questionnaires(change from baseline, after 3, 6 and 12 months)
- Therapy compliance(change from baseline, after 3, 6 and 12 months)
- Cardiovascular parameters(change from baseline, after 3, 6 and 12 months)