Belgian Central Sleep Apnea REgistry

Universitaire Ziekenhuizen KU Leuven1,500 enrolled

Overview

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).

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

1,500

Conditions

Central Sleep Apnea

Interventions

No interventionOTHER

Routine care (registry)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

OLV Ziekenhuis

Aalst, Belgium

RECRUITING

ZNA Middelheim

Antwerp, Belgium

RECRUITING

Outcomes

Primary Outcomes

Treatment choice

Proportion of patients treated with the different treatment modalities

Time frame: 5 years

Secondary Outcomes

Factors determining treatment choice

Relation between patient and CSA characteristics and the treatment choice

Time frame: 5 years

Treatment compliance

Compliance to the different treatment modalities

Time frame: 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.

Time frame: 5 years

Pitssburgh Sleep Quality index

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

Time frame: 5 years

Mortality

Proportion of subjects alive with different treatment modalities

Time frame: 5 years

Central Contacts

Dries Testelmans, MD, PhD

CONTACT

16 342522 dries.testelmans@uzleuven.be

Data from ClinicalTrials.gov

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