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NCT Number: NCT03621566

Belgian Central Sleep Apnea REgistry

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).

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Key information

Conditions

Central Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Central Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OLV Ziekenhuis, Aalst, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Routine care (registry)

Primary outcomes

  1. Treatment choice

    Time frame: 5 years

    Proportion of patients treated with the different treatment modalities

Secondary outcomes

  1. Factors determining treatment choice

    Time frame: 5 years

    Relation between patient and CSA characteristics and the treatment choice

  2. Treatment compliance

    Time frame: 5 years

    Compliance to the different treatment modalities

  3. Short Form 36 Health Survey

    Time frame: 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.

  4. Pitssburgh Sleep Quality index

    Time frame: 5 years

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

  5. Mortality

    Time frame: 5 years

    Proportion of subjects alive with different treatment modalities

Study contacts

Contact information is provided by the study sponsor or research team.

Dries Testelmans, MD, PhD

CONTACT

[email protected]

16 342522 ext. +32

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Philips Respironics

Registry information

Official study title

Belgian Central Sleep Apnea REgistry (B-CARE)

Acronym: B-CARE

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Aug 8, 2018
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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