No registrations found.
ID
Source
Brief title
Health condition
Obstructive sleepapnea
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in the selected biomarkers before and after OSA treatment
Secondary outcome
Changes in AHI, ODI 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
Biomarkers could replace PSG in diagnosis and the follow-up of OSA and provide targeted treatment
Study design
Invasive measurement: venepunction prior and after 3-6 months of OSA treatment.
Non-invasive measurement: PSG prior and after 6 months OSA treatment (standard care)
Inclusion criteria
- 18 years and older
- Diagnosed with OSA confirmed by a PSG (AHI≥5 events per hour)
Exclusion criteria
- Central sleep apnea syndrome (>50% of central apneas)
- Inability to provide informed consent
Design
Recruitment
IPD sharing statement
Plan description
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 |
---|---|
NTR-new | NL8781 |
Other | MEC-U : R20.021 (NL72652.100.20) |