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CompletedNCT00280800Updated Oct 30, 2017

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

An interventional study of constant CPAP devices and automatic CPAP devices in Sleep Apnea, Obstructive, sponsored by Konrad E. Bloch. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-30.

Sponsored by Konrad E. Bloch · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
208
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Sleep Apnea, Obstructive

Keywords

  • randomized
  • controlled
  • double blind
  • effectiveness
  • auto CPAP
  • treatment
  • sleep apnea
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 208 is above the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

This is the only study on the registry with Konrad E. Bloch as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Excessive sleepiness, and Epworth Sleepiness Score > or = 8
  • Apnea- Hypopnea-Index (AHI) > or = 10/hour
  • Age 18-75

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
208 participants (actual)

Study arms

  • Active comparator
    1

    constant CPAP

    Device: constant CPAP devices

  • Experimental
    2

    automatic CPAP

    Device: automatic CPAP devices

Interventions

  • Deviceconstant CPAP devices

    different CPAP mode

  • Deviceautomatic CPAP devices

    different CPAP mode

06

What researchers measure

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

07

Study locations

1 site
  • Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich
    Zürich, CH-8091, Switzerland
08

References and documents

Publications

  • Crook S, Sievi NA, Bloch KE, Stradling JR, Frei A, Puhan MA, Kohler M. Minimum important difference of the Epworth Sleepiness Scale in obstructive sleep apnoea: estimation from three randomised controlled trials. Thorax. 2019 Apr;74(4):390-396. doi: 10.1136/thoraxjnl-2018-211959. Epub 2018 Aug 12. PubMed 30100576 ↗
  • Bloch KE, Huber F, Furian M, Latshang TD, Lo Cascio CM, Nussbaumer-Ochsner Y, Senn O, Russi EW, Kohler M, Schoch OD, Turk A, Imhof E, Laube I, Matthews F, Thurnheer R. Autoadjusted versus fixed CPAP for obstructive sleep apnoea: a multicentre, randomised equivalence trial. Thorax. 2018 Feb;73(2):174-184. doi: 10.1136/thoraxjnl-2016-209699. Epub 2017 Oct 5. PubMed 28982804 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00280800
Lead sponsor
Konrad E. Bloch
Collaborators
University of Zurich, Kantonsspital Münsterlingen, Zuercher Hoehenklinik Wald, Cantonal Hospital of St. Gallen
Responsible party
Konrad E. Bloch (Professor, University of Zurich) — Sponsor-investigator
First posted
Jan 23, 2006
Start date
Jan 2006
Primary completion
Dec 2013
Completion
Mar 2014
Last update
Oct 30, 2017

Study contacts

Konrad E Bloch, MD
study chair · Pulmonary Division and Sleep Disorders Center, University Hospital of Zürich, Switzerland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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