NCT00280800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2006

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

7.9 years

First QC Date

January 20, 2006

Last Update Submit

October 26, 2017

Conditions

Sleep Apnea, Obstructive

Keywords

randomizedcontrolleddouble blindeffectivenessauto CPAPtreatmentsleep apnea

Outcome Measures

Primary Outcomes (6)

  • subjective sleepiness and other OSAS symptoms

    3 months, 1 year, 2 years

  • quality of life

    3 months, 1 year, 2 years

  • percentage of withdrawal and cross-over to other CPAP mode

    3 months, 1 year, 2 years

  • objective vigilance

    3 months, 1 year, 2 years

  • blood pressure

    3 months, 1 year, 2 years

  • cost/utility ratios

    3 months, 1 year, 2 years

Secondary Outcomes (5)

  • major outcomes in subgroups of patients with severe and mild OSAS

    3 months, 1 year, 2 years

  • circulating markers of inflammation and cardiovascular risk

    3 months, 1 year, 2 years

  • side effects

    3 months, 1 year, 2 years

  • nocturnal respiratory disturbances

    3 months, 1 year, 2 years

  • treatment adherence

    3 months, 1 year, 2 years

Study Arms (2)

1

ACTIVE COMPARATOR

constant CPAP

Device: constant CPAP devices

2

EXPERIMENTAL

automatic CPAP

Device: automatic CPAP devices

Interventions

constant CPAP devicesDEVICE

different CPAP mode

1
automatic CPAP devicesDEVICE

different CPAP mode

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich

Zurich, CH-8091, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 30100576DERIVED

  • 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.

    PMID: 28982804DERIVED

Related Links

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Konrad E Bloch, MD

    Pulmonary Division and Sleep Disorders Center, University Hospital of Zürich, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 20, 2006

First Posted

January 23, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

October 30, 2017

Record last verified: 2017-10

Locations

CH(1)