Economic evaluation of treatment modalities for position dependent obstructive sleep apnea patients<br>
- Conditions
- Obstructive sleep apnea sydrome (OSAS)sleep-disordered breathing (SDB)10046304
- Registration Number
- NL-OMON44815
- Lead Sponsor
- Onze Lieve Vrouwe Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 130
- Diagnosis with symptomatic mild or 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.
- 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
- Not specified
- Primary Outcome Measures
Name Time Method <p>primary ouctome: AHI </p><br>
- Secondary Outcome Measures
Name Time Method <p>1) Outcome of Quality of Life questionnaires; EQ-5D, ESS and FOSQ.<br /><br>2) (Societal) costs of treatment; Healthcare Consumption, Illness and Work<br /><br>(HCIW) questionnaire (PCQ/MCQ, successors of TiC-P and PRODISQ).<br /><br>3) Compliance, i.e. more than 4 hours of usage per night.<br /><br>4) Cardiovascular parameters: blood pressure, pulse rate, BMI and neck<br /><br>circumference</p><br>