Clinical trial NCT03621566: Belgian Central Sleep Apnea REgistry
Official title: Belgian Central Sleep Apnea REgistry (B-CARE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Sleep Apnea
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Philips Respironics
First posted: 2018-08-08
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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)

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.

Eligibility 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

Primary outcomes:
measure: Treatment choice
timeFrame: 5 years
Secondary outcomes:
measure: Factors determining treatment choice
timeFrame: 5 years
measure: Treatment compliance
timeFrame: 5 years
measure: Short Form 36 Health Survey
timeFrame: 5 years
measure: Pitssburgh Sleep Quality index
timeFrame: 5 years
measure: Mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Ziekenhuis
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Antwerp
country: Belgium
facility: UZA
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Brussels
country: Belgium
facility: CHU Saint-Pierre
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: La Louvière
country: Belgium
facility: CH Jolimont
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHR de la Citadelle
city: Namur
country: Belgium
facility: CHU UCL Namur
city: Ronse
country: Belgium
facility: AZ Glorieux
city: Turnhout
country: Belgium
facility: AZ Turnhout
Study officials:
affiliation: UZ Leuven
name: Dries Testelmans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: