Evaluating oxygen levels in patients with suspected obstructive sleep apnea
Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea
This study is testing how oxygen levels change during sleep in people who might have obstructive sleep apnea by monitoring them at home and in the hospital to see how different factors affect these changes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT04675268 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the variability of nocturnal oxygen and photoplethysmography (PPG) parameters in patients suspected of having obstructive sleep apnea (OSA) over seven nights at home, alongside one night of diagnostic polysomnography in a hospital setting. The research will analyze factors such as sleep position, alcohol intake, and sleep duration to understand their impact on oxygen variability. Additionally, the study will compare home-measured parameters with those obtained during in-hospital testing and explore the implications of these findings on a newly developed algorithm for assessing apnea-hypopnea index (AHI). This exploratory approach seeks to lay the groundwork for future multi-site studies addressing the cardiovascular and psychological burdens associated with OSA.
Who should consider this trial
Good fit: Ideal candidates for this study are adults suspected of having obstructive sleep apnea who require polysomnography for diagnosis.
Not a fit: Patients under 18 years old or those with conditions that impair their ability to consent or understand the study will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of obstructive sleep apnea, potentially enhancing patient outcomes.
How similar studies have performed: While this approach is exploratory, similar studies have shown promise in evaluating sleep-related parameters and their impact on health outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven
- University Hospitals Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Bertien Buyse, MD, PhD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Bertien Buyse, MD, PhD
- Email: Bertien.Buyse@uzleuven.be
- Phone: +32 16 342522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.