'obstructive sleep apnea syndrome' and 'sleep apnea'
Conditions
Interventions
A bibloc oral appliance (Thornton Adjustable Positioner, Airway Management
Inc., Dallas, TX, USA) will be made for all patients and will be fitted at 70%
of the patient*s maximum mandibular protrusi
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: severe OSAS (AHI >30) Age > 20 years.
Exclusion criteria
Exclusion criteria: Medical and psychological exclusion: 1. Morphologic abnormalities of the upper airway 2. Endocrine dysfunction 3. Reported or documented severe cardiac- or pulmonary co-morbidity 4. Psychiatric disorders Dental exclusion for Oral Appliance therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility for planning a main randomised controlled study to compare OA-CPAP with CPAP alone. Patient*s satisfaction to an OA-CPAP with a questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| An ambulant polysomnography will be assessed for the AHI (efficacy), arousals, sleep stages and oxyhemoglobin saturation. Compliance is operationalized by assessing the number of hours per night and the number of nights per week that the device is used (questionnaire). Side-effects, EDS (excessive daytime sleepiness ) and neurobehavioral outcomes will also be evaluated with a questionnaire. | — |
Countries
Netherlands
Outcome results
None listed