Biomarkers could replace PSG in diagnosis and the follow-up of OSA and provide targeted treatment
ID
Bron
Verkorte titel
Aandoening
Obstructive sleepapnea
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Changes in the selected biomarkers before and after OSA treatment
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Biomarkers could replace PSG in diagnosis and the follow-up of OSA and provide targeted treatment
Onderzoeksopzet
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)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 18 years and older
- Diagnosed with OSA confirmed by a PSG (AHI≥5 events per hour)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Central sleep apnea syndrome (>50% of central apneas)
- Inability to provide informed consent
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
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In overige registers
Register | ID |
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NTR-new | NL8781 |
Ander register | MEC-U : R20.021 (NL72652.100.20) |