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

Study Overview
=================
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
-----------------
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 To investigate the cost of autoCPAP compared to fixed CPAP therapy

Official Title
-----------------
Effectiveness of Auto-adjusted Continuous Positive Airway Pressure for Long-term Treatment of Obstructive Sleep Apnea Syndrome

Conditions
-----------------
Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Device: constant CPAP devices
* Device: automatic CPAP devices


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>constant CPAP | Device: constant CPAP devices<br>* different CPAP mode<br>|
| Experimental: 2<br>automatic CPAP | Device: automatic CPAP devices<br>* different CPAP mode<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major outcomes in subgroups of patients with severe and mild OSAS |  | 3 months, 1 year, 2 years | 
| circulating markers of inflammation and cardiovascular risk |  | 3 months, 1 year, 2 years | 
| side effects |  | 3 months, 1 year, 2 years | 
| nocturnal respiratory disturbances |  | 3 months, 1 year, 2 years | 
| treatment adherence |  | 3 months, 1 year, 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
randomized, controlled, double blind, effectiveness, auto CPAP, treatment, sleep apnea