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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02712060
First Posted: March 17, 2016
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University Children's Hospital, Zurich
Ehlers-Danlos Net Switzerland
Information provided by (Responsible Party):
Malcolm Kohler, University of Zurich
  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 Malcolm Kohler, 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 ]

Enrollment: 50
Study Start Date: March 2016
Study Completion Date: May 2017
Primary Completion Date: May 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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712060


Locations
Switzerland
Division of Pulmonology, University Hospital Zurich
Zurich, Switzerland, 8091
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
First Submitted: March 14, 2016
First Posted: March 17, 2016
Last Update Posted: May 15, 2017
Last Verified: May 2017

Keywords provided by Malcolm Kohler, 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