Condition category
Nervous System Diseases
Date applied
13/05/2009
Date assigned
14/07/2009
Last edited
15/08/2011
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

Dr Malcolm Kohler

ORCID ID

Contact details

Sleep Disorders Centre and Pulmonary Division
University Hospital of Zurich
Raemistrasse 100
Zurich
8091
Switzerland
+41 (0)44 255 97 51
Malcolm.K@bluewin.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V1.1

Study information

Scientific title

Continuous positive airway pressure therapy withdrawal - a model to evaluate treatment modalities for sleep apnoea: a randomised controlled trial

Acronym

Study hypothesis

Continuous positive airway pressure (CPAP) therapy withdrawal will result in gradual deterioration in daytime symptoms of obstructive sleep apnoea (OSA), sleep study parameters of OSA severity and an increase of blood pressure, endothelial dysfunction and systemic inflammation.

Ethics approval

Local ethics committee of the University Hospital of Zurich approved on the 13th January 2009 (ref: EK-1600)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Obstructive sleep apnoea

Intervention

Obstructive sleep apnoea patients under treatment with continuous positive airway pressure (CPAP) will be randomised to either continue with CPAP or to sham CPAP for 2 weeks. Total time of follow-up is 2 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Severity and symptoms of OSA, measured at least at baseline, after 1 week and after 2 weeks.

Secondary outcome measures

1. Blood pressure
2. Endothelial function
3. Systemic inflammation

Measured at least at baseline, after 1 week and after 2 weeks.

Overall trial start date

01/07/2009

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Objectively confirmed obstructive sleep apnoea with an original oxygen desaturation index (ODI) (greater than or equal to 4% dips) of between 10 and 50/h
2. Currently greater than 10 oxygen desaturations (greater than or equal to 4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP
3. Treated with CPAP for more than 12 months, minimal compliance 4 hours per night
4. Written informed consent
5. Aged 20 - 75 years (inclusive), either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Previous ventilatory failure (awake resting arterial oxygen saturation less than 93% or arterial partial pressure of carbon dioxide [PCO2] greater than 6 kPa)
2. Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension (greater than 180/110 mmHg)
3. Previously diagnosed with Cheyne-Stokes breathing
4. Current professional driver
5. Any sleep related accident
6. Aged less than 20 or greater than 75 years at trial entry
7. Mental or physical disability precluding informed consent or compliance with the protocol
8. Non-feasible trial follow-up (for example, distance from follow-up centre, physical inability)

Recruitment start date

01/07/2009

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Switzerland

Trial participating centre

Sleep Disorders Centre and Pulmonary Division
Zurich
8091
Switzerland

Sponsor information

Organisation

University Hospital of Zurich (Switzerland)

Sponsor details

c/o Dr Malcolm Kohler
Sleep Disorders Centre and Pulmonary Division
Raemistrasse 100
Zurich
8091
Switzerland
Malcolm.K@bluewin.ch

Sponsor type

Hospital/treatment centre

Website

http://www.unizh.ch/

Funders

Funder type

Research organisation

Funder name

Swiss National Science Foundation (Switzerland) (ref: 32003B_124915/1)

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

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. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21836134

Publication citations

  1. Results

    Kohler M, Stoewhas AC, Ayers L, Senn O, Bloch KE, Russi EW, Stradling JR, Effects of continuous positive airway pressure therapy withdrawal in patients with obstructive sleep apnea: a randomized controlled trial., Am. J. Respir. Crit. Care Med., 2011, 184, 10, 1192-1199, doi: 10.1164/rccm.201106-0964OC.

Additional files

Editorial Notes