Belgian Central Sleep Apnea REgistry

Study Overview
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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.

Official Title
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Belgian Central Sleep Apnea REgistry (B-CARE)

Conditions
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Central Sleep Apnea

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Central Sleep Apnea<br>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<br>* Routine care (registry)<br>|

What is the study measuring?
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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 |