Obstructive sleep apnoea Nervous System Diseases Sleep disorders
Conditions
Interventions
After a CPAP titration night patients will be randomised to three months of either BiPAP auto with Biflex or fixed level CPAP. Patients will be followed up at 1, 4, 8 and 12 weeks.
Sponsors
Respironics International, Inc. (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Apnoea/Hypopnoea Index (AHI) greater than 15/h 2. Aged greater than or equal to 21 years and less than or equal to 65 years, either sex 3. Body mass index (BMI) less than 40 kg/m^2 4. Able to follow the study protocol 5. Successful CPAP titration
Exclusion criteria
Exclusion criteria: 1. Drug abuse 2. Intake of central relevant drugs, sedatives, or other drugs with impairment of sleep 3. Alcohol abuse; consume more than 30 g/d 4. Participation in other clinical-pharmacological studies up to 4 weeks prior of study begin 5. Psychiatric or neurological diseases resulting in impairment of sleep, therapy or compliance 6. Thyroidal dysfunction 7. Chronic pain syndromes 8. Acute cardiac, pulmonary, and other internal diseases 9. Chronic cardiac, pulmonary and other internal diseases resulting in impairment of sleep 10. Central sleep-related breathing disorders or other disorders resulting in hypoventilation 11. Periodic leg movements (PLM)/restless legs syndrome (RLS) 12. Previous exposure to either CPAP or bilevel therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment and therapeutic efficacy will be measured by polysomnography (PSG) at diagnosis, titration and 12 weeks (end of study). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective compliance measured by device memory download at one week and the end of the study 2. Subjective compliance and parameters of wellbeing measured at baseline, 4, 8, 12 weeks 3. Epworth Sleepiness Scale measured at baseline (after diagnostic PSG and after titration PSG), 4, 8 and 12 weeks 4. Pittsburgh Sleep Quality Index measured at baseline (after diagnostic PSG only), 4, 8 and 12 weeks 5. Functional Outcomes of Sleep Questionnaire measured at baseline (after diagnostic PSG only), 4, 8 and 12 weeks 6. Calgary Sleep Apnoea Quality of Life Index measured at baseline (after diagnostic PSG only), 4, 8 and 12 weeks 7. 12-item Short Form (SF-12) measured at baseline (after diagnostic PSG only), 4, 8 and 12 weeks 8. Visual Analogue Scale measured in the morning and evening at baseline (after diagnostic PSG and after titration PSG), 4, 8 and 12 weeks 9. Treatment Satisfaction Visual Analogue Scale measured at baseline (after titration PSG only), 4, 8 and 12 weeks 10. Treatment Comfort Visual Analogue Scale measured at baseline (after titration PSG only), 4, 8 and 12 weeks 11. Mask/Interface Comfort Visual Analogue Scale measured at baseline (after titration PSG only), 4, 8 and 12 weeks | — |
Countries
Germany
Outcome results
None listed