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OpenTrials
Completed

NCT Number: NCT00280800

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

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.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich

Zurich, CH-8091, Switzerland

About this study

  • 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
  • To investigate the cost of autoCPAP compared to fixed CPAP therapy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

constant CPAP devices

Device

different CPAP mode

automatic CPAP devices

Device

different CPAP mode

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Konrad E. Bloch

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2013
Study completion
2014
First posted
Jan 23, 2006
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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