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

October 26, 2017 updated by: Konrad E. Bloch

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konrad E. Bloch

Collaborators

University of Zurich
Cantonal Hospital of St. Gallen
Kantonsspital Münsterlingen
Zuercher Hoehenklinik Wald

Investigators

  • Study Chair: Konrad E Bloch, MD, Pulmonary Division and Sleep Disorders Center, University Hospital of Zürich, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 20, 2006

First Submitted That Met QC Criteria

January 20, 2006

First Posted (Estimate)

January 23, 2006

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 1187

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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