Sleepiness and Sleep-disordered Breathing in Fabry Disease. A Prospective Cohort Study.
Cross-sectional Study on the Incidence of Sleepiness and Sleep-disordered Breathing in Patients With Fabry Disease
1 other identifier
interventional
52
1 country
1
Brief Summary
Prospective, observational cohort study to investigate the prevalence of sleepiness and sleep-related breathing disorders in patients with Fabry disease (FD). For this, an Epworth Sleepiness Score (ESS) and ambulatory overnight respiratory polygraphy (oRP) is obtained in all subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 12, 2013
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMarch 3, 2015
February 1, 2015
1.3 years
September 12, 2013
March 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence and type of sleep-related breathing disorder in Fabry patients.
Prevalence and type of sleep-related breathing disorder in Fabry patients measured with overnight ambulatory respiratory polygraphy.
Day 1
Study Arms (1)
ResMed Apnea Link plus
EXPERIMENTALOvernight respiratory polygraphy is performed in Fabry patients
Interventions
Overnight respiratory polygraphy to detect sleep-related breathing disorders is performed in Fabry patients
Eligibility Criteria
You may qualify if:
- are 18 years or above
- have signed informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich, Division of Internal Medicine
Zurich, Canton of Zurich, 8091, Switzerland
Related Publications (1)
Franzen D, Gerard N, Bratton DJ, Wons A, Gaisl T, Sievi NA, Clarenbach CF, Kohler M, Krayenbuhl PA. Prevalence and Risk Factors of Sleep Disordered Breathing in Fabry disease: A Prospective Cohort Study. Medicine (Baltimore). 2015 Dec;94(52):e2413. doi: 10.1097/MD.0000000000002413.
PMID: 26717401DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Franzen, MD
University Hospital Zurich, Division of Internal Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2013
First Posted
September 20, 2013
Study Start
September 1, 2013
Primary Completion
January 1, 2015
Study Completion
February 1, 2015
Last Updated
March 3, 2015
Record last verified: 2015-02