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 |
| Protocol serial number | 170/10 |
| Sponsor | University Hospital Basel (Switzerland) |
| Funder | University Hospital Basel (Switzerland) - Clinic of Pneumology and Respiratory Cell Research |
- 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
Scientific
Clinic of Pneumology and Respiratory Cell Research
University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational longitudinal single centre study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| 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 |
| Study acronym | BioSAFE |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Change in median circulating copeptin, Pro-ANP and Pro-ADM levels after 1 month of CPAP or BiPAP treatment |
| Key secondary outcome measure(s) |
1. Median circulating copeptin, Pro-ANP and Pro-ADM levels before treatment and after 1 and 6 months of treatment respectively |
| Completion date | 30/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. Patients aged 18 or older 2. Patients with suspicion of obstructive sleep apnoea syndrome or central apnoea events |
| Key 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 |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 30/04/2012 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Clinic of Pneumology and Respiratory Cell Research
Basel
4031
Switzerland
4031
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
