Belgian Central Sleep Apnea REgistry

Recruiting

• Conditions: Central Sleep Apnea
• Interventions: Other: No intervention

• Registration Number: NCT03621566
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2018-06-25
• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2028-06-25
• Study Completion: 2028-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Central Sleep Apnea	No intervention	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)

Primary Outcome Measures

Name	Time	Method
Treatment choice	5 years	Proportion of patients treated with the different treatment modalities

Secondary Outcome Measures

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

Trial Locations

Locations (14)

OLV Ziekenhuis; 🇧🇪 Aalst, Belgium

UZA; 🇧🇪 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

AZ Glorieux; 🇧🇪 Ronse, Belgium

AZ Turnhout; 🇧🇪 Turnhout, Belgium

ZNA Middelheim; 🇧🇪 Antwerp, Belgium

CHU UCL Namur; 🇧🇪 Namur, Belgium