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

No publications provided

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 History of Changes
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:

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

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

ClinicalTrials.gov processed this record on May 07, 2009