Belgian Central Sleep Apnea REgistry

NCT ID: NCT03621566

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-25

Study Completion Date

2028-06-25

Brief Summary

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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

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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.

Conditions

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Central Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No intervention

Intervention Type OTHER

Routine care (registry)

Interventions

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No intervention

Routine care (registry)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philips Respironics

INDUSTRY

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dries Testelmans, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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OLV Ziekenhuis

Aalst, , Belgium

Site Status RECRUITING

ZNA Middelheim

Antwerp, , Belgium

Site Status RECRUITING

UZA

Antwerp, , Belgium

Site Status RECRUITING

AZ Sint-Jan

Bruges, , Belgium

Site Status RECRUITING

CHU Saint-Pierre

Brussels, , Belgium

Site Status RECRUITING

Ghent University Hospital

Ghent, , Belgium

Site Status RECRUITING

Jessa Ziekenhuis

Hasselt, , Belgium

Site Status RECRUITING

AZ Groeninge

Kortrijk, , Belgium

Site Status RECRUITING

CH Jolimont

La Louvière, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

CHR de la Citadelle

Liège, , Belgium

Site Status RECRUITING

CHU UCL Namur

Namur, , Belgium

Site Status RECRUITING

AZ Glorieux

Ronse, , Belgium

Site Status RECRUITING

AZ Turnhout

Turnhout, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Dries Testelmans, MD, PhD

Role: CONTACT

16 342522 ext. +32

Facility Contacts

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Berend-Jan Berendes, MD

Role: primary

Lieven Bedert, MD

Role: primary

Johan Verbraecken, MD, PhD

Role: primary

Veerle Ringoet, MD

Role: primary

Marie Bruyneel, MD, PhD

Role: primary

Katrien Hertegonne, MD, PhD

Role: primary

Karolien Weytjens, MD

Role: primary

Sofie Maddens, MD

Role: primary

Alain Volckaert, MD

Role: primary

Dries Testelmans, MD, PhD

Role: primary

Farhad Baharloo, MD

Role: primary

Thibaut Vandenhove, MD

Role: primary

Edwin Hill, MD

Role: primary

Maryse Van den Heuvel, MD

Role: primary

Other Identifiers

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B322201835950

Identifier Type: -

Identifier Source: org_study_id

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