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

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ClinicalTrials.gov Identifier: NCT00280800
Recruitment Status : Completed
First Posted : January 23, 2006
Last Update Posted : October 30, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Sleep Apnea, Obstructive Device: constant CPAP devices Device: automatic CPAP devices

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Auto-adjusted Continuous Positive Airway Pressure for Long-term Treatment of Obstructive Sleep Apnea Syndrome
Study Start Date : January 2006
Primary Completion Date : December 2013
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
constant CPAP
Device: constant CPAP devices
different CPAP mode
Experimental: 2
automatic CPAP
Device: automatic CPAP devices
different CPAP mode


Outcome Measures

Primary Outcome Measures :
  1. subjective sleepiness and other OSAS symptoms [ Time Frame: 3 months, 1 year, 2 years ]
  2. quality of life [ Time Frame: 3 months, 1 year, 2 years ]
  3. percentage of withdrawal and cross-over to other CPAP mode [ Time Frame: 3 months, 1 year, 2 years ]
  4. objective vigilance [ Time Frame: 3 months, 1 year, 2 years ]
  5. blood pressure [ Time Frame: 3 months, 1 year, 2 years ]
  6. cost/utility ratios [ Time Frame: 3 months, 1 year, 2 years ]

Secondary Outcome Measures :
  1. major outcomes in subgroups of patients with severe and mild OSAS [ Time Frame: 3 months, 1 year, 2 years ]
  2. circulating markers of inflammation and cardiovascular risk [ Time Frame: 3 months, 1 year, 2 years ]
  3. side effects [ Time Frame: 3 months, 1 year, 2 years ]
  4. nocturnal respiratory disturbances [ Time Frame: 3 months, 1 year, 2 years ]
  5. treatment adherence [ Time Frame: 3 months, 1 year, 2 years ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280800


Locations
Switzerland
Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich
Zürich, Switzerland, CH-8091
Sponsors and Collaborators
Konrad E. Bloch
University of Zurich
Kantonsspital Münsterlingen
Zuercher Hoehenklinik Wald
Cantonal Hospital of St. Gallen
Investigators
Study Chair: Konrad E Bloch, MD Pulmonary Division and Sleep Disorders Center, University Hospital of Zürich, Switzerland
More Information

Additional Information:
Responsible Party: Konrad E. Bloch, Professor, University of Zurich
ClinicalTrials.gov Identifier: NCT00280800     History of Changes
Other Study ID Numbers: EK 1187
First Posted: January 23, 2006    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Keywords provided by Konrad E. Bloch, University of Zurich:
randomized
controlled
double blind
effectiveness
auto CPAP
treatment
sleep apnea

Additional relevant MeSH terms:
Sleep Disorders, Intrinsic
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases