Registry for patients with central sleep apnea in Belgium
Belgian Central Sleep Apnea REgistry (B-CARE)
This study is collecting information from patients with central sleep apnea in Belgium to see how different factors affect their treatment choices and how well they stick to their treatment plans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 14 sites (Aalst and 13 other locations) |
| Trial ID | NCT03621566 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates various factors influencing treatment choices and compliance among patients diagnosed with central sleep apnea (CSA) in Belgium. It aims to gather data on the clinical features, treatment algorithms, and outcomes associated with CSA, which is characterized by significant interruptions in breathing during sleep. All participants will receive routine care while contributing to a registry that tracks their treatment experiences and adherence. The study seeks to enhance understanding of CSA and improve treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with central sleep apnea as indicated by an apnea/hypopnea index of 15 or more.
Not a fit: Patients with mental disabilities that prevent them from understanding the study protocol will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols and better management of central sleep apnea, enhancing patient outcomes.
How similar studies have performed: While there is ongoing research into central sleep apnea, this registry approach is relatively novel and aims to fill gaps in understanding treatment compliance and outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * An apnea/hypopnea index ≥ 15/h of sleep and proportion of non-obstructive events \> 50%, derived from polysomnography (diagnostic or during (PAP) treatment) * Written informed consent provided Exclusion Criteria: \- Patients with mental disability making it impossible to understand the study protocol
Where this trial is running
Aalst and 13 other locations
- OLV Ziekenhuis — Aalst, Belgium (Recruiting)
- ZNA Middelheim — Antwerp, Belgium (Recruiting)
- Uza — Antwerp, Belgium (Recruiting)
- AZ Sint-Jan — Bruges, Belgium (Recruiting)
- CHU Saint-Pierre — Brussels, Belgium (Recruiting)
- Ghent University Hospital — Ghent, Belgium (Recruiting)
- Jessa Ziekenhuis — Hasselt, Belgium (Recruiting)
- AZ Groeninge — Kortrijk, Belgium (Recruiting)
- CH Jolimont — La Louvière, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- CHR de la Citadelle — Liège, Belgium (Recruiting)
- CHU UCL Namur — Namur, Belgium (Recruiting)
- AZ Glorieux — Ronse, Belgium (Recruiting)
- AZ Turnhout — Turnhout, Belgium (Recruiting)
Study contacts
- Principal investigator: Dries Testelmans, MD, PhD — UZ Leuven
- Study coordinator: Dries Testelmans, MD, PhD
- Email: dries.testelmans@uzleuven.be
- Phone: 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.