Therapy efficacy, compliance and long-term outcome of Auto-bilevel therapy compared to continuous positive airway pressure (CPAP) therapy in obstructive sleep apnoea (OSA) patients

Completed

• Conditions: Obstructive sleep apnoea; Nervous System Diseases; Sleep disorders

• Registration Number: ISRCTN53816305
• Lead Sponsor: Respironics International, Inc. (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified