Obstructive Sleep Apnea-Hypopnoea Syndrome
Conditions
Interventions
Participating subjects will receive randomly two modes of PAP-therapy. One PAP
mode will be given constant pressure (CPAP) and the other mode will deliver
restricted APAP treatment (RAPAP). Both tre
Sponsors
Medisch Spectrum Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects of 18 years or older PAP-therapy naive patients with confirmed OSAHS Moderate OSAHS - AHI 15 - 30 events/hours and a least mild sleepiness Severe OSAHS - AHI > 30 events/hours and at leat mild sleepiness Moderate to severe sleepiness with AHI > 5 events/hours Able to understand, read and write Dutch
Exclusion criteria
Exclusion criteria: Central sleep apnea syndrome Cheyne-Stokes respiration Signs of severe nasal obstruction Major facial or pharyngeal anatomic abnormalities likely to require surgery. Previous surgical treatment of UPPP Night or rotating shift work Severe chronic heart failure class IV Chronic Obstructive Pulmonary Disease defined by the GOLD-criteria stage 3 to 4 (i.e., forced expiratory volume in 1 s [FEV1]/forced vital capacity [FVC]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is patient*s adherence for treatment modes. It is measured by recording the amount of sleeping time per night in hours with the PAP device. Amendement: Regression formula predicting the optimal pressure setting for sleep apnea patients for the population that was investigated and may be extrapolated to sleep apnea patients overall. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: subjective: sleepiness (Epworth Sleepiness Score), quality of life (disease specific: Quebec Sleep Questionnaire, and generic: SF-36), preference for treatment mode and tolerance, and objective: polygraphy with both PAP treatment modes and by downloading data (AHI) of the PAP device. | — |
Countries
Netherlands
Outcome results
None listed