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)

ISRCTN ISRCTN02302064
DOI https://doi.org/10.1186/ISRCTN02302064
Secondary identifying numbers 170/10
Submission date
16/08/2010
Registration date
28/10/2010
Last edited
28/10/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Daiana Stolz
Scientific

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

Study information

Study designProspective observational longitudinal single centre study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleCopeptin, 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
Study acronymBioSAFE
Study objectivesThe 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(s)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)
Health condition(s) or problem(s) studiedObstructive sleep apnoea syndrome (OSAS)
InterventionVisit 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 typeOther
Primary outcome measureChange in median circulating copeptin, Pro-ANP and Pro-ADM levels after 1 month of CPAP or BiPAP treatment
Secondary outcome measures1. 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 study start date01/09/2010
Completion date30/04/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants300
Key inclusion criteria1. Patients aged 18 or older
2. Patients with suspicion of obstructive sleep apnoea syndrome or central apnoea events
Key exclusion criteria1. 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
Date of first enrolment01/09/2010
Date of final enrolment30/04/2012

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Clinic of Pneumology and Respiratory Cell Research
Basel
4031
Switzerland

Sponsor information

University Hospital Basel (Switzerland)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/04k51q396

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan