Belgian Central Sleep Apnea REgistry (B-CARE)

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).

Study Overview

• Status: Recruiting
• Conditions: Central Sleep Apnea
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Dries Testelmans, MD, PhD; Phone Number: +32 16 342522; Email: dries.testelmans@uzleuven.be

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Recruiting
    • OLV Ziekenhuis
    • Contact: Berend-Jan Berendes, MD
  • Antwerp, Belgium, 2020
    • Recruiting
    • ZNA Middelheim
    • Contact: Lieven Bedert, MD
  • Antwerp, Belgium, 2650
    • Recruiting
    • UZA
    • Contact: Johan Verbraecken, MD, PhD
  • Brugge, Belgium, 8000
    • Recruiting
    • AZ Sint-Jan
    • Contact: Veerle Ringoet, MD
  • Brussels, Belgium, 1000
    • Recruiting
    • CHU Saint-Pierre
    • Contact: Marie Bruyneel, MD, PhD
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Katrien Hertegonne, MD, PhD
  • Hasselt, Belgium, 3500
    • Recruiting
    • Jessa Ziekenhuis
    • Contact: Karolien Weytjens, MD
  • Kortrijk, Belgium, 8500
    • Recruiting
    • Az Groeninge
    • Contact: Sofie Maddens, MD
  • La Louvière, Belgium, 7100
    • Recruiting
    • CH Jolimont
    • Contact: Alain Volckaert, MD
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Dries Testelmans, MD, PhD
  • Liège, Belgium, 4000
    • Recruiting
    • CHR de la Citadelle
    • Contact: Farhad Baharloo, MD
  • Namur, Belgium, 5530
    • Recruiting
    • Chu Ucl Namur
    • Contact: Thibaut Vandenhove, MD
  • Ronse, Belgium, 9600
    • Recruiting
    • AZ Glorieux
    • Contact: Edwin Hill, MD
  • Turnhout, Belgium, 2300
    • Recruiting
    • Az Turnhout
    • Contact: Maryse Van den Heuvel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Other: No intervention; Routine care (registry)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment choice	Proportion of patients treated with the different treatment modalities	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors determining treatment choice	Relation between patient and CSA characteristics and the treatment choice	5 years
Treatment compliance	Compliance to the different treatment modalities	5 years
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
Pitssburgh Sleep Quality index	To measure sleep quality and disturbances. Score range: 0-21 points, with lower scores indicating better sleep quality.	5 years
Mortality	Proportion of subjects alive with different treatment modalities	5 years

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Philips Respironics
• Investigators: Principal Investigator: Dries Testelmans, MD, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 25, 2018
• Primary Completion (ANTICIPATED): June 25, 2028
• Study Completion (ANTICIPATED): June 25, 2028

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (ACTUAL): August 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea; Sleep Apnea, Central
• Other Study ID Numbers: B322201835950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No