NCT04675268 Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea (OSA)
| NCT ID | NCT04675268 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2021-01-26 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2021-01-26 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators would like to evaluate the variability of oxygen (and PPG) parameters during 7 nights at home. Oxygen (and PPG) parameters will also be evaluated during 1 night at the hospital (diagnostic polysomnography). Based on currently developed algorithms, surrogate apnea-hypopnea index (AHI), cardiovascular status and the variability of these parameters will be evaluated.
Eligibility Criteria
Inclusion Criteria: * Patients with suspected OSA with a clinical indication to perform a polysomnography Exclusion Criteria: * Patients younger than 18 yrs * Patients not able to read or understand the informed consent content on the purpose of the study, due to visual, intellectual or language issues * Patients with neuromuscular disease or chest wall disease with suspected hypoventilation
Contact & Investigator
Bertien Buyse, MD, PhD
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT04675268 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04675268 currently recruiting?
Yes, NCT04675268 is actively recruiting participants. Contact the research team at Bertien.Buyse@uzleuven.be for enrollment information.
Where is the NCT04675268 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT04675268 clinical trial?
NCT04675268 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Bertien Buyse, MD, PhD at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 130 participants.