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Trial record 1 of 1 for:    NCT02712060
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Obstructive Sleep Apnoea in Children and Adolescents With Ehlers-Danlos Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Zurich
Sponsor:
Collaborators:
University Children's Hospital, Zurich
Ehlers-Danlos Net Switzerland
Information provided by (Responsible Party):
Malcolm Kohler, University of Zurich
ClinicalTrials.gov Identifier:
NCT02712060
First received: March 14, 2016
Last updated: October 24, 2016
Last verified: October 2016
  Purpose

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.


Condition Intervention
Ehler's Danlos Syndrome
Obstructive Sleep Apnea
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Obstructive Sleep Apnoea in Children and Adolescents With Ehlers-Danlos Syndrome

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Prevalence of OSA in children and adolescents with EDS [ Time Frame: up to 12 months ]

Secondary Outcome Measures:
  • Quality of life in children and adolescents with EDS [ Time Frame: up to 12 months ]

Estimated Enrollment: 50
Study Start Date: March 2016
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
EDS patients
Patients with the diagnosis of Ehlers-Danlos syndrome
Other: No intervention
controls
Patients/Subjects without the diagnosis of Ehlers-Danlos syndrome
Other: No intervention

Detailed 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 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 compared to a matched control group. 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.

  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02712060

Contacts
Contact: Malcolm Kohler, MD +41 44 255 3828 malcolm.kohler@usz.ch
Contact: Anna Stöberl, MD +41 44 255 1743 annasophie.stoeberl@usz.ch

Locations
Switzerland
Division of Pulmonology, University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Malcolm Kohler, Prof. MD    +4144255111    malcolm.kohler@usz.ch   
Contact: Anna Stöberl, MD    +41442551743    annasophie.stoeberl@usz.ch   
Sponsors and Collaborators
University of Zurich
University Children's Hospital, Zurich
Ehlers-Danlos Net Switzerland
Investigators
Principal Investigator: Malcolm Kohler, MD University of Zurich
  More Information

Responsible Party: Malcolm Kohler, Prof. Dr. med., University of Zurich
ClinicalTrials.gov Identifier: NCT02712060     History of Changes
Other Study ID Numbers: KEK-ZHNr. 2015-0144
Study First Received: March 14, 2016
Last Updated: October 24, 2016

Keywords provided by University of Zurich:
Ehlers-Danlos Syndrome
Obstructive Sleep Apnea
Prevalence
Children
Pediatric
Adolescents

Additional relevant MeSH terms:
Syndrome
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Ehlers-Danlos Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 25, 2017