Condition category
Circulatory System
Date applied
16/04/2007
Date assigned
16/05/2007
Last edited
11/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Winfried Randerath

ORCID ID

Contact details

Wissenschaftliches Institut Bethanien e.V.
Aufderhoherstrasse 169
Solingen
42699
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Rand001

Study information

Scientific title

Acronym

Study hypothesis

BiPAP® autoSV™ is superior to Continuous Positive Airway Pressure (CPAP) in reducing breathing disturbances during sleep and improving cardiac function.

Ethics approval

Approved by the local ethics committee (Universitat Witten/Herdecke Ethik-Kommission) on the 4th September 2006.

Study design

Randomised controlled double blind trial of BiPAP® autoSV™ therapy versus CPAP

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Sleep disordered breathing and cardiovascular disease.

Intervention

Control:
Nasal Continuous Positive Airway Pressure (CPAP) is the current gold standard treatment for Obstructive Sleep Apnoea Syndrome. CPAP can crudely be described as a small air pump attached to a mask that is worn over the nose and pumps a fixed amount of pressurised air through the nares to prevent upper airway collapse whilst sleeping.

Intervention:
Adaptive Servo-Ventilation machines (ASV) provide Expiratory Positive Airway Pressure (EPAP) or CPAP support to sustain upper-airway patency as with a CPAP machine but also modulate the Inspiratory Positive Airway Pressure (IPAP) in response to central and cheyne-stokes events.

After a baseline polysomnography (first night) patients are randomly assigned to either CPAP or BiPAP® autoSV™. They will then undergo two titration nights on therapy. After the first titration night the patients are asked for side-effects using a standardised questionnaire. On the fourth night the titrated values are validated. The CPAP level should be set to greater than or equal to 10 mbar.

After 3 months and 12 months the patients are re-evaluated polysomographically and have outcomes measured. The devices are also read out for treatment compliance. After six months and nine months the patients are contacted by telephone to find out any problems with mask, device or compliance.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Central AHI, measured at baseline, 3 and 12 months.

Secondary outcome measures

1. Total AHI, measured at baseline, 3 and 12 months
2. Maximal oxygen uptake (VO2 max), measured at baseline, 3 and 12 months
3. Left ventricular ejection fraction (echocardiography), measured at baseline, 3 and 12 months
4. Minimal and mean oxygen saturation (polysomnography), measured at baseline, 3 and 12 months
5. Compliance, measured at 3 and 12 months only
6. Quality of life (Minnesota questionnaire), measured at baseline, 3 and 12 months
7. Brain Natriuretic Peptide (BNP) level, measured at baseline, 3 and 12 months
8. Mortality, measured at 3 and 12 months only
9. Rate of cardiovascular complications, for example hospital admissions are examined for twelve months, measured at 3 and 12 months only

Overall trial start date

01/01/2007

Overall trial end date

01/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women 18 years of age and older
2. Arterial hypertension, ischaemic heart disease, idiopathic dilated cardiomyopathy with heart failure functional class New York Heart Association (NYHA) II and III and left ventricular ejection fraction greater than 20% (echocardiography)
3. Mixed sleep apnoea syndrome with an Apnoea Hypopnoea Index (AHI) greater than or equal to 15/hour with a proportion of central/periodic disturbances of less than 80% and a proportion of obstructive disturbances of between 20 and 50%
4. Medical treatment of their underlying heart disease has been optimised

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant exclusion criteria

1. Heart failure functional class NYHA IV
2. Myocardial infarction, unstable angina or cardiac surgery within the previous three months, obstructive disturbances of 50% or greater
3. Pregnancy
4. Patients with pure Cheyne-Stokes Respiration (CSR)/Central Sleep Apnoea (CSA) (greater than 80% of disturbances), patients with greater than 50% obstructive disturbances

Recruitment start date

01/01/2007

Recruitment end date

01/07/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Wissenschaftliches Institut Bethanien e.V.
Solingen
42699
Germany

Sponsor information

Organisation

Respironics International, Inc (France)

Sponsor details

Immeuble Hermès
20
rue Jacques Daguerre
Rueil Malmaison
Paris
92565
France

Sponsor type

Industry

Website

http://www.respironics.com

Funders

Funder type

Industry

Funder name

Respironics International, Inc (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22281801

Publication citations

  1. Results

    Randerath WJ, Nothofer G, Priegnitz C, Anduleit N, Treml M, Kehl V, Galetke W, Long-term auto-servoventilation or constant positive pressure in heart failure and coexisting central with obstructive sleep apnea., Chest, 2012, 142, 2, 440-447, doi: 10.1378/chest.11-2089.

Additional files

Editorial Notes