Effectiveness of Auto-adjusted Continuous Positive Airway Pressure for Long-term Treatment of Sleep Apnea

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: constant CPAP devices; Device: automatic CPAP devices

• Registration Number: NCT00280800
• Lead Sponsor: Konrad E. Bloch

Brief Summary

Hypothesis: Computer controlled continuous positive airway pressure (autoCPAP) is equally effective in improving obstructive sleep apnea syndrome symptoms, breathing disturbances, objective vigilance, and it is cost-effective compared to conventional fixed continuous positive airway pressure.

Detailed Description

1. To investigate whether computer controlled continuous positive airway pressure (autoCPAP) improves subjective sleepiness, quality of life, objective vigilance, and nocturnal respiration to a similar degree as conventional fixed continuous positive airway pressure in the initial phase of treatment and over the subsequent 2 years during home therapy

2. To investigate the cost of autoCPAP compared to fixed CPAP therapy

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-20
• Study First Submitted QC: 2006-01-20
• Study First Posted: 2006-01-23
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• Excessive sleepiness, and Epworth Sleepiness Score > or = 8
• Apnea- Hypopnea-Index (AHI) > or = 10/hour
• Age 18-75

Exclusion Criteria

• Psychophysiological incapacity to perform questionnaires
• Other sleep disorders
• Psychiatric disease requiring treatment
• Previous CPAP therapy
• Previous uvulopalatopharyngoplasty
• Chronic nasal obstruction that required treatment for more than 1 month
• Cancer
• COPD, with FEV1 < 50% predicted
• Symptomatic cardiovascular disease requiring treatment defined as congestive heart failure > NYHA II
• Previous stroke with neurological residuum
• Cheyne-Stokes respiration
• Chronic pain syndromes, fibromyalgia
• Drug or alcohol addiction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	constant CPAP devices	constant CPAP
2	automatic CPAP devices	automatic CPAP

Primary Outcome Measures

Name	Time	Method
subjective sleepiness and other OSAS symptoms	3 months, 1 year, 2 years
percentage of withdrawal and cross-over to other CPAP mode	3 months, 1 year, 2 years
blood pressure	3 months, 1 year, 2 years
cost/utility ratios	3 months, 1 year, 2 years
quality of life	3 months, 1 year, 2 years
objective vigilance	3 months, 1 year, 2 years

Secondary Outcome Measures

Name	Time	Method
major outcomes in subgroups of patients with severe and mild OSAS	3 months, 1 year, 2 years
treatment adherence	3 months, 1 year, 2 years
circulating markers of inflammation and cardiovascular risk	3 months, 1 year, 2 years
nocturnal respiratory disturbances	3 months, 1 year, 2 years
side effects	3 months, 1 year, 2 years

Trial Locations

Locations (1)

Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich; 🇨🇭 Zürich, Switzerland