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

This study has been completed.
Sponsor:
Collaborators:
University of Zurich
Kantonsspital Münsterlingen
Zürcher Höhenklinik Wald, Switzerland
Cantonal Hospital of St. Gallen
Information provided by (Responsible Party):
Konrad E. Bloch, University of Zurich
ClinicalTrials.gov Identifier:
NCT00280800
First received: January 20, 2006
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ]

Enrollment: 208
Study Start Date: January 2006
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
constant CPAP
Device: constant CPAP devices
different CPAP mode
Experimental: 2
automatic CPAP
Device: automatic CPAP devices
different CPAP mode

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Zürcher Höhenklinik Wald, Switzerland
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

No publications provided

Responsible Party: Konrad E. Bloch, Professor, University of Zurich
ClinicalTrials.gov Identifier: NCT00280800     History of Changes
Other Study ID Numbers: EK 1187
Study First Received: January 20, 2006
Last Updated: May 14, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by 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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014