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Central Sleep ApneaB-CARENCT03621566

Belgian Central Sleep Apnea REgistry

An observational study of Central Sleep Apnea, run by Universitaire Ziekenhuizen KU Leuven at 14 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Central Sleep Apnea
How many people
1,500 participants
Where
14 sitesBelgium
Study dates
25 Jun 2018to 25 Jun 2028
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • 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

Who cannot join

  • Patients with mental disability making it impossible to understand the study protocol

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dries Testelmans, MD, PhD contact

16 342522 ext. +32

dries.testelmans@uzleuven.be

14 sites in 1 country

Belgium14 sites, 14 recruiting

  • OLV Ziekenhuis

    Aalst, 9300

    Berend-Jan Berendes, MD

    Recruiting

  • ZNA Middelheim

    Antwerp, 2020

    Lieven Bedert, MD

    Recruiting

  • UZA

    Antwerp, 2650

    Johan Verbraecken, MD, PhD

    Recruiting

  • AZ Sint-Jan

    Bruges, 8000

    Veerle Ringoet, MD

    Recruiting

  • CHU Saint-Pierre

    Brussels, 1000

    Marie Bruyneel, MD, PhD

    Recruiting

  • Ghent University Hospital

    Ghent, 9000

    Katrien Hertegonne, MD, PhD

    Recruiting

  • Jessa Ziekenhuis

    Hasselt, 3500

    Karolien Weytjens, MD

    Recruiting

  • AZ Groeninge

    Kortrijk, 8500

    Sofie Maddens, MD

    Recruiting

  • CH Jolimont

    La Louvière, 7100

    Alain Volckaert, MD

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Dries Testelmans, MD, PhD

    Recruiting

  • CHR de la Citadelle

    Liège, 4000

    Farhad Baharloo, MD

    Recruiting

  • CHU UCL Namur

    Namur, 5530

    Thibaut Vandenhove, MD

    Recruiting

  • AZ Glorieux

    Ronse, 9600

    Edwin Hill, MD

    Recruiting

  • AZ Turnhout

    Turnhout, 2300

    Maryse Van den Heuvel, MD

    Recruiting

Other trials in Belgium

About this study

Official title: Belgian Central Sleep Apnea REgistry (B-CARE)

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).

Read the 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.

Being tested
No intervention
Medical subject headings
Sleep Apnea, Central

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    Routine care (registry)

Study groups in NCT03621566
Study groupRoleWhat they receive
Central Sleep ApneaSubjects 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)
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment choice

    Proportion of patients treated with the different treatment modalities

    Measured: 5 years

Secondary outcomes (5)

  1. Factors determining treatment choice

    Relation between patient and CSA characteristics and the treatment choice

    Measured: 5 years

  2. Treatment compliance

    Compliance to the different treatment modalities

    Measured: 5 years

  3. 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.

    Measured: 5 years

  4. Pitssburgh Sleep Quality index

    To measure sleep quality and disturbances. Score range: 0-21 points, with lower scores indicating better sleep quality.

    Measured: 5 years

  5. Mortality

    Proportion of subjects alive with different treatment modalities

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2018
  2. Study start25 Jun 2018
  3. Primary completion25 Jun 2028 (estimated)
  4. Study completion25 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03621566
Sponsor's protocol ID
B322201835950
Acronym
B-CARE
Status last verified
Jul 2024
First submitted
5 Jul 2018
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Central Sleep Apnea, run by Universitaire Ziekenhuizen KU Leuven at 14 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dries Testelmans, MD, PhD (16 342522 ext. +32, dries.testelmans@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment choice (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03621566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.

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