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
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