To identify biomarkers associated with OSA and OSA disease severity by investigating whether there are biomarkers in agreement with PSG, pre- and post-treatment and does OSA treatment result in improvement of these markers associated with…
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in the selected biomarkers before and after OSA treatment.
Secondary outcome
Changes in AHI and subjective outcomes correlated to changes in biomarkers.
Background summary
Obstructive sleep apnea (OSA) is a problem of epidemic proportions. Even though
accurate statistics are lacking, it*s roughly estimated that a 10-15% of the
European population is suffering from it. OSA can be treated through a number
of procedures like Continuous Positive Airway Pressure (CPAP), Maxillofacial
Surgery (MMA), ENT Surgery, Upper Airway Stimulation (UAS), Mandibular
Advancement Device (MAD), and Positional Therapy (PT). The effect of treatment
can be established by repeated sleep studies. Although Polysomnography (PSG) is
the gold standard for diagnosing OSA, repeating standard PSG*s in all patients
is time consuming and expensive. The Dasman Diabetes Institute has a biomarker
panel that has potential for monitoring the severity and treatment effect of
OSA. Identification of a blood biomarker, collected from venepuncture, can
provide a less expensive, less time consuming and more patient friendly
diagnosic tool than PSG. Replacement of PSG for accurate biomarkers would
provide a worldwide opportunity for all OSA clinics to simplify baseline and
follow-up standard OSA screening.
Study objective
To identify biomarkers associated with OSA and OSA disease severity by
investigating whether there are biomarkers in agreement with PSG, pre- and
post-treatment and does OSA treatment result in improvement of these markers
associated with cardiovascular and metabolic diseases.
Study design
Single center prospective case-control study.
Study burden and risks
Following the hospital protocol all patients visiting the hospital for OSA
screening receive a PSG after which will be decided whether treatment is
necessary. The best treatment option will be evaluated for every patient. After
CPAP treatment and UAS, a post-treatment PSG is already standard performed. An
additional procedure for this cohort will be plasma extraction prior and after
treatment.
Jan Tooropstraat 164
Amsterdam 1061AE
NL
Jan Tooropstraat 164
Amsterdam 1061AE
NL
Listed location countries
Age
Inclusion criteria
- 18 years and older
- Diagnosed with OSA confirmed by a PSG (AHI*30 events per hour)
Exclusion criteria
- Central sleep apnea syndrome (>50% of central apneas)
- Inability to provide informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL72652.100.20 |