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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02435745
Other study ID # KEK-ZH-Nr. 2015-0144
Secondary ID
Status Completed
Phase N/A
First received April 27, 2015
Last updated December 10, 2015
Start date April 2015
Est. completion date December 2015

Study information

Verified date December 2015
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial 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 patients with EDS is unknown.

Aortic root dilation and dissection are common complications of EDS and little is known about the underlying risk factors. Preliminary evidence suggests a link with OSA but this has not yet been investigated.

The primary objective of this study is to assess the prevalence of OSA in EDS-patients (100) compared to a matched control group (100). The secondary objective of this pioneer study is to assess whether there is a relationship between OSA severity and aortic diame-ter/craniofacial abnormalities in EDS patients.


Description:

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 patients with EDS is unclear.

Aortic dilation and dissection are complications associated with EDS and little is known about the underlying risk factors. Preliminary evidence suggests a link with OSA but this has not yet been investigated.

The primary objective of this study is to assess the prevalence of OSA in EDS-patients compared to a matched control group. The secondary objective of the study is to assess whether there is a relationship between OSA severity and craniofacial phenotypes / aortic diameter in EDS patients.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Informed consent

- Diagnosis of Ehlers-Danlos Syndrome (not for control group)

Exclusion Criteria:

- 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Switzerland Division of Pulmonology, University Hospital Zurich Zurich

Sponsors (3)

Lead Sponsor Collaborator
University of Zurich Ehlers-Danlos Net Switzerland, University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of OSA up to 12 months No
Secondary Craniofacial phenotyping up to 12 months No
Secondary Aortic diameter up to 12 months No
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