Belgian Central Sleep Apnea REgistry
B-CARE
1 other identifier
observational
1,500
1 country
14
Brief Summary
This study evaluates different factors that determine the treatment choice and treatment compliance in patients with central sleep apnea. All patients will receive routine care (registry).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 25, 2018
CompletedFirst Submitted
Initial submission to the registry
July 5, 2018
CompletedFirst Posted
Study publicly available on registry
August 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 25, 2028
July 3, 2024
July 1, 2024
10 years
July 5, 2018
July 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment choice
Proportion of patients treated with the different treatment modalities
5 years
Secondary Outcomes (5)
Factors determining treatment choice
5 years
Treatment compliance
5 years
Short Form 36 Health Survey
5 years
Pitssburgh Sleep Quality index
5 years
Mortality
5 years
Study Arms (1)
Central Sleep Apnea
Subjects with an apnea/hypopnea index ≥ 15/h of sleep and proportion of non-obstructive events \> 50%, derived from polysomnography (diagnostic or during positive airway pressure treatment)
Interventions
Eligibility Criteria
Subjects with an apnea/hypopnea index ≥ 15/h of sleep and proportion of non-obstructive events \> 50%, derived from polysomnography (diagnostic or during positive airway pressure treatment)
You may qualify if:
- 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
You may not qualify if:
- \- Patients with mental disability making it impossible to understand the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitaire Ziekenhuizen KU Leuvenlead
- Philips Respironicscollaborator
Study Sites (14)
OLV Ziekenhuis
Aalst, 9300, Belgium
ZNA Middelheim
Antwerp, 2020, Belgium
UZA
Antwerp, 2650, Belgium
AZ Sint-Jan
Bruges, 8000, Belgium
CHU Saint-Pierre
Brussels, 1000, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
Jessa Ziekenhuis
Hasselt, 3500, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
CH Jolimont
La Louvière, 7100, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHR de la Citadelle
Liège, 4000, Belgium
CHU UCL Namur
Namur, 5530, Belgium
AZ Glorieux
Ronse, 9600, Belgium
AZ Turnhout
Turnhout, 2300, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dries Testelmans, MD, PhD
UZ Leuven
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2018
First Posted
August 8, 2018
Study Start
June 25, 2018
Primary Completion (Estimated)
June 25, 2028
Study Completion (Estimated)
June 25, 2028
Last Updated
July 3, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share