Condition category
Respiratory
Date applied
16/08/2010
Date assigned
28/10/2010
Last edited
28/10/2010
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 Daiana Stolz

ORCID ID

Contact details

Clinic of Pneumology and Respiratory Cell Research
University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

170/10

Study information

Scientific title

Copeptin, Pro-Atrial Natriuretic Peptide (Pro-ANP) and Pro-Adrenomedullin (Pro-ADM) as markers of hypoxic stress in patients with obstructive sleep apnoea syndrome (OSAS): a prospective intervention trial

Acronym

BioSAFE

Study hypothesis

The primary objective of this trial is to evaluate, whether copeptin, Pro-ANP and Pro-ADM might serve as a potential proxy for prognosis and therapy response in OSAS or patients with central events by reliable reflecting hypoxic stress and responding to Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) therapy respectively. Further clinical and laboratorial predictors of therapy approve and prognosis will also be evaluated.

Ethics approval

The conjoined local ethic committee of the cantons of Basel-Stadt and Basel-Land approved on the 23rd of August 2010 (ref: EKBB 170/10)

Study design

Prospective observational longitudinal single centre study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

Obstructive sleep apnoea syndrome (OSAS)

Intervention

Visit 1a: informed consent, medical history, current medical status, demographics, vital signs, height and body weight, epworth sleepiness score, SF-36, overnight pulsoxymetry
Visit 1b: venous puncture (6 and 9 am), overnight pulsoxymetry
Visit 2a (Baseline): medical history, physical examination, vital signs, venous puncture (8 and 10 pm), overnight pulsoxymetry
Visit 2b (Baseline): venous puncture (6 and 9 am), epworth sleepiness score, SF-36
Visit 3 (1 Month): current medical status, physical examination, vital signs, height and body weight, venous puncture (6 and 9 am), epworth sleepiness score, SF-36, overnight pulsoxymetry
Visit 4 (6 months): current medical status, physical examination, vital signs, height and body weight, venous puncture (6 and 9 am), epworth sleepiness score, SF-36, overnight pulsoxymetry

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in median circulating copeptin, Pro-ANP and Pro-ADM levels after 1 month of CPAP or BiPAP treatment

Secondary outcome measures

1. Median circulating copeptin, Pro-ANP and Pro-ADM levels before treatment and after 1 and 6 months of treatment respectively
2. Change in median circulating copeptin, Pro-ANP and Pro-ADM levels after 1 night and 6 months of CPAP treatment respectively
In a second step, endpoints will be assessed in subgroups of patients according to OSAS severity

Overall trial start date

01/09/2010

Overall trial end date

30/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 18 or older
2. Patients with suspicion of obstructive sleep apnoea syndrome or central apnoea events

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Mental disorder preventing appropriate judgment concerning study participation
2. Significant co morbidity resulting in reduced life expectancy (lower than 6 months)
3. Planned emigration or relocation within the country during the study period
4. Pregnancy and breast-feeding

Recruitment start date

01/09/2010

Recruitment end date

30/04/2012

Locations

Countries of recruitment

Switzerland

Trial participating centre

Clinic of Pneumology and Respiratory Cell Research
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel (Switzerland)

Sponsor details

Prof. Michael Tamm
Clinic of Pneumology and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Basel (Switzerland) - Clinic of Pneumology and Respiratory Cell Research

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

Publication citations

Additional files

Editorial Notes