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Belgian Central Sleep Apnea REgistry

Belgian Central Sleep Apnea REgistry (B-CARE)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03621566
Acronym
B-CARE
Enrollment
1500
Registered
2018-08-08
Start date
2018-06-25
Completion date
2028-06-25
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Sleep Apnea

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).

Detailed description

Central sleep apnea (CSA) is characterized by intermittent cessation or decrease of airflow and effort of breathing during sleep. The diagnostic criteria for CSA varies according to the type of CSA (e.g. CSA due to cardiac failure, due to a medication, ...). CSA is defined as: (1) an apnea/hypopnea index ≥ 15 per hour of sleep and (2) the number of central apneas and/or hypopneas is \> 50% of the total number of apneas and hypopneas. Presence of CSA is associated with excessive daytime sleepiness and poor sleep quality. Furthermore, in patients with heart failure, presence of CSA was found to be related to mortality. As yet, however, there is insufficient knowledge on the clinical features, pathophysiological background and consecutive algorithms for treatment. Currently, it is not fully clear whether CSA or the treatment of CSA is related to disease progress. The aim of this trial is to evaluate the current treatment choices for CSA in Belgium and compliance with and effects of these treatments.

Interventions

OTHERNo intervention

Routine care (registry)

Sponsors

Philips Respironics
CollaboratorINDUSTRY
Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment choice5 yearsProportion of patients treated with the different treatment modalities

Secondary

MeasureTime frameDescription
Factors determining treatment choice5 yearsRelation between patient and CSA characteristics and the treatment choice
Treatment compliance5 yearsCompliance to the different treatment modalities
Short Form 36 Health Survey5 yearsTo measure eight domains of health Content: * physical functioning * role limitations due to physical health * bodily pain * general health perceptions * vitality * social functioning * role limitations due to emotional problems * mental health Number of items: 36 items are included in scoring Score interpretation: each item scored on a 0 to 100 range so that the lower and highest possible scores are set at 0 and 100. Scores represent the percentage of total possible score achieved.
Pitssburgh Sleep Quality index5 yearsTo measure sleep quality and disturbances. Score range: 0-21 points, with lower scores indicating better sleep quality.
Mortality5 yearsProportion of subjects alive with different treatment modalities

Countries

Belgium

Contacts

Primary ContactDries Testelmans, MD, PhD
dries.testelmans@uzleuven.be16 342522

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026