Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Philips Respironics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Central Sleep Apnea | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Routine care (registry) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment choice | Proportion of patients treated with the different treatment modalities | 5 years |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Patients with mental disability making it impossible to understand the study protocol
Not provided
Not provided
Not provided
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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dries Testelmans, MD, PhD | Contact | 16 342522 | +32 | dries.testelmans@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Dries Testelmans, MD, PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Ziekenhuis | Recruiting | Aalst | 9300 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 5 years |
| Short Form 36 Health Survey | To measure eight domains of health Content:
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 |
| ZNA Middelheim | Recruiting | Antwerp | 2020 | Belgium |
|
| UZA | Recruiting | Antwerp | 2650 | Belgium |
|
| AZ Sint-Jan | Recruiting | Bruges | 8000 | Belgium |
|
| CHU Saint-Pierre | Recruiting | Brussels | 1000 | Belgium |
|
| Ghent University Hospital | Recruiting | Ghent | 9000 | Belgium |
|
| Jessa Ziekenhuis | Recruiting | Hasselt | 3500 | Belgium |
|
| AZ Groeninge | Recruiting | Kortrijk | 8500 | Belgium |
|
| CH Jolimont | Recruiting | La Louvière | 7100 | Belgium |
|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
|
| CHR de la Citadelle | Recruiting | Liège | 4000 | Belgium |
|
| CHU UCL Namur | Recruiting | Namur | 5530 | Belgium |
|
| AZ Glorieux | Recruiting | Ronse | 9600 | Belgium |
|
| AZ Turnhout | Recruiting | Turnhout | 2300 | Belgium |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |