Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT03621566
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2018-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Belgian Central Sleep Apnea REgistry
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Study Overview
Official Title:
Belgian Central Sleep Apnea REgistry (B-CARE)
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
B-CARE
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: