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

NCT ID: NCT00280800

Last Updated: 2017-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Sleep Apnea, Obstructive

Keywords

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randomized controlled double blind effectiveness auto CPAP treatment sleep apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

constant CPAP

Group Type ACTIVE_COMPARATOR

constant CPAP devices

Intervention Type DEVICE

different CPAP mode

2

automatic CPAP

Group Type EXPERIMENTAL

automatic CPAP devices

Intervention Type DEVICE

different CPAP mode

Interventions

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constant CPAP devices

different CPAP mode

Intervention Type DEVICE

automatic CPAP devices

different CPAP mode

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

Kantonsspital Münsterlingen

OTHER

Sponsor Role collaborator

Zuercher Hoehenklinik Wald

OTHER

Sponsor Role collaborator

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role collaborator

Konrad E. Bloch

OTHER

Sponsor Role lead

Responsible Party

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Konrad E. Bloch

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Konrad E Bloch, MD

Role: STUDY_CHAIR

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

Locations

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Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 30100576 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28982804 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/?term=28982804

Bloch KE et al. Thorax 2017;0:1-11

http://dx.doi.org/10.1136/thoraxjnl-2016-209699

Link to publication

Other Identifiers

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EK 1187

Identifier Type: -

Identifier Source: org_study_id