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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 21 December 2015
Main ID:  NCT02435745
Date of registration: 27/04/2015
Prospective Registration: No
Primary sponsor: University of Zurich
Public title: Obstructive Sleep Apnoea in Ehlers-Danlos Syndrome OSA in EDS
Scientific title: Obstructive Sleep Apnoea in Ehlers-Danlos Syndrome
Date of first enrolment: April 2015
Target sample size: 200
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02435745
Study type:  Observational
Study design:  Observational Model: Case Control, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Switzerland
Contacts
Name:     Malcolm Kohler, Prof. MD
Address: 
Telephone:
Email:
Affiliation:  University of Zurich
Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Ehlers-Danlos Syndrome
Obstructive Sleep Apnea
Intervention(s)
Primary Outcome(s)
Prevalence of OSA [Time Frame: up to 12 months]
Secondary Outcome(s)
Aortic diameter [Time Frame: up to 12 months]
Craniofacial phenotyping [Time Frame: up to 12 months]
Secondary ID(s)
KEK-ZH-Nr. 2015-0144
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ehlers-Danlos Net Switzerland
University Children's Hospital, Zurich
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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