Clinical trial NCT00280800: Effectiveness of Auto-adjusted Continuous Positive Airway Pressure for Long-term Treatment of Sleep Apnea
Official title: Effectiveness of Auto-adjusted Continuous Positive Airway Pressure for Long-term Treatment of Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: randomized
controlled
double blind
effectiveness
auto CPAP
treatment
sleep apnea
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Zurich
name: Kantonsspital Münsterlingen
name: Zuercher Hoehenklinik Wald
name: Cantonal Hospital of St. Gallen
First posted: 2006-01-23
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: subjective sleepiness and other OSAS symptoms
timeFrame: 3 months, 1 year, 2 years
measure: quality of life
timeFrame: 3 months, 1 year, 2 years
measure: percentage of withdrawal and cross-over to other CPAP mode
timeFrame: 3 months, 1 year, 2 years
measure: objective vigilance
timeFrame: 3 months, 1 year, 2 years
measure: blood pressure
timeFrame: 3 months, 1 year, 2 years
measure: cost/utility ratios
timeFrame: 3 months, 1 year, 2 years
Secondary outcomes:
measure: major outcomes in subgroups of patients with severe and mild OSAS
timeFrame: 3 months, 1 year, 2 years
measure: circulating markers of inflammation and cardiovascular risk
timeFrame: 3 months, 1 year, 2 years
measure: side effects
timeFrame: 3 months, 1 year, 2 years
measure: nocturnal respiratory disturbances
timeFrame: 3 months, 1 year, 2 years
measure: treatment adherence
timeFrame: 3 months, 1 year, 2 years
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich
Study officials:
affiliation: Pulmonary Division and Sleep Disorders Center, University Hospital of Zürich, Switzerland
name: Konrad E Bloch, MD
role: STUDY_CHAIR
References:
citation: Crook S, Sievi NA, Bloch KE, Stradling JR, Frei A, Puhan MA, Kohler M. Minimum important difference of the Epworth Sleepiness Scale in obstructive sleep apnoea: estimation from three randomised controlled trials. Thorax. 2019 Apr;74(4):390-396. doi: 10.1136/thoraxjnl-2018-211959. Epub 2018 Aug 12.
citation: Bloch KE, Huber F, Furian M, Latshang TD, Lo Cascio CM, Nussbaumer-Ochsner Y, Senn O, Russi EW, Kohler M, Schoch OD, Turk A, Imhof E, Laube I, Matthews F, Thurnheer R. Autoadjusted versus fixed CPAP for obstructive sleep apnoea: a multicentre, randomised equivalence trial. Thorax. 2018 Feb;73(2):174-184. doi: 10.1136/thoraxjnl-2016-209699. Epub 2017 Oct 5.