Obstructive Sleep Apnoea in Adolescents With Thoracic Aortic Aneurysm

NCT03400319 | Completed DMC

• 1 other identifier: KEK-ZH-Nr. 2014-0035 CTRL
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thoracic Aortic Aneurysm Without Rupture; Obstructive Sleep Apnea

Keywords

Thoracic Aortic Aneurysm; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Prevalence of Obstructive Sleep Apnea

  Prevalence of Obstructive Sleep Apnea according to a Sleep study (The ApneaLink™)

  Baseline

Study Arms (2)

Thoracic Aortic Aneurysm

Patients with Thoracic Aortic Aneurysm: Women: at the level of the sinus of valsalva ≥39mm, or ascending aorta ≥42mm. Men: at the level of the sinus of valsalva ≥44mm, or ascending aorta ≥46mm.

No Thoracic Aortic Aneurysm

Patients without Thoracic Aortic Aneurysm: Women: at the level of the sinus of valsalva \<39mm, or ascending aorta \<42mm. Men: at the level of the sinus of valsalva \<44mm, or ascending aorta \<46mm.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with and without Thoracic Aortic Aneurysm

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Pulmonary Division

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: July 5, 2014
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)