Effectiveness of Auto-Adjusted Continuous Positive Airway Pressure for Long-Term Treatment of Sleep Apnea - Full Text View

Sponsors and Collaborators:	University of Zurich Kantonsspital Münsterlingen, Switzerland Zürcher Höhenklinik Wald, Switzerland University Hospital, Basel, Switzerland
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00280800

Purpose

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

Condition	Intervention
Sleep Apnea, Obstructive	Device: constant CPAP devices Device: automatic CPAP devices

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effectiveness of Auto-Adjusted Continuous Positive Airway Pressure for Long-Term Treatment of Obstructive Sleep Apnea Syndrome

Further study details as provided by University of Zurich:

Primary Outcome Measures:

subjective sleepiness and other OSAS symptoms [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
quality of life [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
percentage of withdrawal and cross-over to other CPAP mode [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
objective vigilance [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
blood pressure [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
cost/utility ratios [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

major outcomes in subgroups of patients with severe and mild OSAS [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
circulating markers of inflammation and cardiovascular risk [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
side effects [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
nocturnal respiratory disturbances [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
treatment adherence [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator constant CPAP	Device: constant CPAP devices different CPAP mode
2: Experimental automatic CPAP	Device: automatic CPAP devices different CPAP mode

Detailed Description:

To investigate whether auto CPAP improves subjective sleepiness, quality of life, objective vigilance, and nocturnal respiration to a similar degree as conventional fixed CPAP in the initial phase of treatment and over the subsequent 2 years during home therapy
To investigate the cost of auto CPAP compared to fixed CPAP therapy

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280800

Contacts

Contact: Konrad E Bloch, MD	41-44-255-2202	pneubloc@usz.uzh.ch
Contact: Yvonne Nussbaumer, MD	41-44-255-1111	Yvonne.Nussbaumer-Ochsener@usz.ch

Locations

Switzerland
Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich	Recruiting
Zürich, Switzerland, CH-8091

Sponsors and Collaborators

University of Zurich

Kantonsspital Münsterlingen, Switzerland

Zürcher Höhenklinik Wald, Switzerland

University Hospital, Basel, Switzerland

Investigators

Study Chair:

Konrad E Bloch, MD

Pulmonary Division and Sleep Disorders Center, University Hospital of Zürich, Switzerland

More Information

Responsible Party:	University Hospital Zurich ( Konrad E. Bloch, MD )
Study ID Numbers:	EK 1187
Study First Received:	January 20, 2006
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00280800
Health Authority:	Switzerland: Swissmedic

Keywords provided by University of Zurich:

randomized
controlled
double blind
effectiveness

auto CPAP
treatment
sleep apnea

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009