Obstructive Sleep Apnoea in Adolescents With Thoracic Aortic Aneurysm

Obstructive Sleep Apnea Clinical Trial

— OSA in TAA  

Official title:

Obstructive Sleep Apnoea in Adolescents With Thoracic Aortic Aneurysm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400319
• Other study ID #: KEK-ZH-Nr. 2014-0035 CTRL
• Status: Completed
• Start date: July 5, 2014
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this prospective cohort study is to determine the prevalence of obstructive sleep apnoea (OSA) in patients with and without thoracic aortic aneurysm.

Description:

The objective of this prospective cohort study is to determine the prevalence of obstructive sleep apnoea (OSA) in patients with and without thoracic aortic aneurysm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years.

• Diagnosis of thoracic aortic aneurysm defined by the following parameters:

Women: at the level of the sinus of valsalva =39mm, or ascending aorta =42mm. (for controls: <39mm and <42mm respectively); Men: at the level of the sinus of valsalva =44mm, or ascending aorta =46mm. (for controls: <44mm and <46mm respectively)

Exclusion Criteria:

• Patients on continuous positive airway pressure (CPAP) therapy for OSA at baseline.

• Patients with known central sleep apnoea.

• Patients on morphine or other opioid medication, heroin addiction, alcohol addiction.

• Patients with moderate or severe aortic regurgitation.

• Patients with moderate or severe aortic stenosis.

• Pregnant patients.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Apnea
• Obstructive Sleep Apnea
• Rupture
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Thoracic Aortic Aneurysm Without Rupture

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Pulmonary Division	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Obstructive Sleep Apnea	Prevalence of Obstructive Sleep Apnea according to a Sleep study (The ApneaLink™)	Baseline