Belgian Central Sleep Apnea REgistry

Central Sleep Apnea Clinical Trial

— B-CARE  

Official title:

Belgian Central Sleep Apnea REgistry (B-CARE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03621566
• Other study ID #: B322201835950
• Status: Recruiting
• Start date: June 25, 2018
• Est. completion date: June 25, 2028

Study information

• Verified date: November 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Dries Testelmans, MD, PhD
• Phone: 16 342522
• Email: dries.testelmans[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 25, 2028
• Est. primary completion date: June 25, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Central

Intervention

Other:
• No intervention
Routine care (registry)

Locations

Country	Name	City	State
Belgium	OLV Ziekenhuis	Aalst
Belgium	UZA	Antwerp
Belgium	ZNA Middelheim	Antwerp
Belgium	AZ Sint-Jan	Brugge
Belgium	CHU Saint-Pierre	Brussels
Belgium	Ghent University Hospital	Ghent
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	AZ Groeninge	Kortrijk
Belgium	CH Jolimont	La Louvière
Belgium	UZ Leuven	Leuven
Belgium	CHR de la Citadelle	Liège
Belgium	CHU UCL Namur	Namur
Belgium	AZ Glorieux	Ronse
Belgium	AZ Turnhout	Turnhout

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Philips Respironics

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment choice	Proportion of patients treated with the different treatment modalities	5 years
Secondary	Factors determining treatment choice	Relation between patient and CSA characteristics and the treatment choice	5 years
Secondary	Treatment compliance	Compliance to the different treatment modalities	5 years
Secondary	Short Form 36 Health Survey	To 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.	5 years
Secondary	Pitssburgh Sleep Quality index	To measure sleep quality and disturbances. Score range: 0-21 points, with lower scores indicating better sleep quality.	5 years
Secondary	Mortality	Proportion of subjects alive with different treatment modalities	5 years