Positional Obstructive Sleep Apnea
Conditions
Keywords
Positional therapy, MAD, Oral appliance, Sleep position trainer, POSA
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.
Interventions
DEVICEContinuous positive airway pressure
DEVICESleep position trainer
DEVICEMandibular advancement device
Sponsors
University Hospital, Antwerp
Onze Lieve Vrouwe Gasthuis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apnea-hypopnea index (AHI) | change from baseline, after 3, 6 and 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Outcome of Quality of Life questionnaires | change from baseline, after 3, 6 and 12 months | EQ-5D |
| (Societal) costs of treatment | change from baseline, after 3, 6 and 12 months | iMTA Productivity Cost Questionnaire (iPCQ) |
| 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 | Systolic and diastolic blood pressure |
Countries
Belgium, Netherlands
Contacts
Primary ContactPatty Vonk, MD
Backup ContactN de Vries, Professor
Outcome results
None listed