Obstructive Sleep Apnoea in Children and Adolescents With Ehlers-Danlos Syndrome

Obstructive Sleep Apnea Clinical Trial

Official title:

Obstructive Sleep Apnoea in Children and Adolescents With Ehlers-Danlos Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712060
• Other study ID #: KEK-ZHNr. 2015-0144
• Status: Completed
• Phase: N/A
• First received: March 14, 2016
• Last updated: May 12, 2017
• Start date: March 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

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

Related Conditions & MeSH terms

• Apnea
• Ehler's Danlos Syndrome
• Ehlers-Danlos Syndrome
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Other:
• No intervention

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 in children and adolescents with EDS		up to 12 months
Secondary	Quality of life in children and adolescents with EDS		up to 12 months