Obstructive Sleep Apnoea in Children and Adolescents With Ehlers-Danlos Syndrome
1 other identifier
observational
50
1 country
1
Brief Summary
Ehlers-Danlos Syndrome (EDS) is a clinically and genetically heterogeneous group of inherited connective tissue disorders characterized by joint hypermobility, skin hyperextensibility, and tissue fragility. EDS features such as genetically related cartilage defects, craniofacial abnormalities and increased pharyngeal collapsibility have been proposed to cause obstructive sleep apnoea (OSA). There is evidence from studies based on questionnaires that EDS patients might be more frequently affected by OSA and sleep disturbances than the general population. However, the actual prevalence of OSA in children and adolescents with EDS is unknown. The primary objective of this study is to assess the prevalence of OSA in children and adolescents with EDS (25) compared to a matched control group (25). The secondary objective of this pioneer study is to assess the quality of life in children and adolescents in EDS in comparison to healthy children and adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2016
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
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
March 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedMay 15, 2017
May 1, 2017
1.2 years
March 14, 2016
May 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of OSA in children and adolescents with EDS
up to 12 months
Secondary Outcomes (1)
Quality of life in children and adolescents with EDS
up to 12 months
Study Arms (2)
EDS patients
Patients with the diagnosis of Ehlers-Danlos syndrome
controls
Patients/Subjects without the diagnosis of Ehlers-Danlos syndrome
Interventions
Eligibility Criteria
Prospective case-control study including children and adolescents from 0-18 with EDS and matched controls. The following outcomes will be assessed: 1) apnoea-hypopnoea index, 2) sleep-related questionnaires, 3) medical chart review
You may qualify if:
- Informed consent
- Diagnosis of Ehlers-Danlos Syndrome (not for control group)
You may not qualify if:
- Moribund or severe disease prohibiting protocol adherence
- Continuous positive airway pressure treatment for OSA during sleep study
- Physical or intellectual impairment precluding informed consent or protocol adherence
- Pregnant patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- University Children's Hospital, Zurichcollaborator
- Ehlers-Danlos Network, Switzerlandcollaborator
Study Sites (1)
Division of Pulmonology, University Hospital Zurich
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Malcolm Kohler, MD
University of Zurich
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
March 14, 2016
First Posted
March 17, 2016
Study Start
March 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
May 15, 2017
Record last verified: 2017-05