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

Primary Purpose

Sleep Apnea, Obstructive

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

constant CPAP devices

automatic CPAP devices

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring randomized, controlled, double blind, effectiveness, auto CPAP, treatment, sleep apnea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

constant CPAP

automatic CPAP

Outcomes

Primary Outcome Measures

subjective sleepiness and other OSAS symptoms

quality of life

percentage of withdrawal and cross-over to other CPAP mode

objective vigilance

blood pressure

cost/utility ratios

Secondary Outcome Measures

major outcomes in subgroups of patients with severe and mild OSAS

circulating markers of inflammation and cardiovascular risk

side effects

nocturnal respiratory disturbances

treatment adherence

Full Information

NCT ID

NCT00280800

First Posted

January 20, 2006

Last Updated

October 26, 2017

Sponsor

Konrad E. Bloch

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00280800

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Konrad E. Bloch

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea, Obstructive

Keywords

randomized, controlled, double blind, effectiveness, auto CPAP, treatment, sleep apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

208 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

constant CPAP

Arm Title

Arm Type

Experimental

Arm Description

automatic CPAP

Intervention Type

Device

Intervention Name(s)

constant CPAP devices

Intervention Description

different CPAP mode

Intervention Type

Device

Intervention Name(s)

automatic CPAP devices

Intervention Description

different CPAP mode

Primary Outcome Measure Information:

Title

subjective sleepiness and other OSAS symptoms

Time Frame

3 months, 1 year, 2 years

Title

quality of life

Time Frame

3 months, 1 year, 2 years

Title

percentage of withdrawal and cross-over to other CPAP mode

Time Frame

3 months, 1 year, 2 years

Title

objective vigilance

Time Frame

3 months, 1 year, 2 years

Title

blood pressure

Time Frame

3 months, 1 year, 2 years

Title

cost/utility ratios

Time Frame

3 months, 1 year, 2 years

Secondary Outcome Measure Information:

Title

major outcomes in subgroups of patients with severe and mild OSAS

Time Frame

3 months, 1 year, 2 years

Title

circulating markers of inflammation and cardiovascular risk

Time Frame

3 months, 1 year, 2 years

Title

side effects

Time Frame

3 months, 1 year, 2 years

Title

nocturnal respiratory disturbances

Time Frame

3 months, 1 year, 2 years

Title

treatment adherence

Time Frame

3 months, 1 year, 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Konrad E Bloch, MD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich

City

Zürich

ZIP/Postal Code

CH-8091

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

30100576

Citation

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.

Results Reference

derived

PubMed Identifier

28982804

Citation

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.

Results Reference

derived

Links:

URL

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

Description

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

URL

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

Description

Link to publication

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

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