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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00280800

Enrollment

208

Registered

2006-01-23

Start date

2006-01-31

Completion date

2014-03-31

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive

Keywords

randomized, controlled, double blind, effectiveness, auto CPAP, treatment, sleep apnea

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

Interventions

DEVICEautomatic CPAP devices

different CPAP mode

DEVICEconstant CPAP devices

different CPAP mode

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
cost/utility ratios	3 months, 1 year, 2 years
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

Secondary

Measure	Time frame
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
major outcomes in subgroups of patients with severe and mild OSAS	3 months, 1 year, 2 years

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026