Health TrialsbyHealthPanel

Belgian Central Sleep Apnea REgistry

ConditionCentral Sleep Apnea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

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)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    Routine care (registry)

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: Central Sleep Apnea1 intervention

Trial outcomes

Primary outcomes

1

Treatment choice

Proportion of patients treated with the different treatment modalities

Time frame
5 years

Secondary outcomes

1

Factors determining treatment choice

Relation between patient and CSA characteristics and the treatment choice

Time frame
5 years
2

Treatment compliance

Compliance to the different treatment modalities

Time frame
5 years
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Philips Respironics

Collaborator

Source ClinicalTrials.gov
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