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Obstructive Sleep Apnoea in Adolescents With Thoracic Aortic Aneurysm (OSA in TAA)

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.
 
ClinicalTrials.gov Identifier: NCT03400319
Recruitment Status : Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease
Thoracic Aortic Aneurysm Without Rupture Obstructive Sleep Apnea

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Obstructive Sleep Apnoea in Adolescents With Thoracic Aortic Aneurysm
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020


Group/Cohort
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.



Primary Outcome Measures :
  1. Prevalence of Obstructive Sleep Apnea [ Time Frame: Baseline ]
    Prevalence of Obstructive Sleep Apnea according to a Sleep study (The ApneaLink™)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with and without Thoracic Aortic Aneurysm
Criteria

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.

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): NCT03400319


Locations
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Switzerland
University Hospital Zurich, Pulmonary Division
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03400319    
Other Study ID Numbers: KEK-ZH-Nr. 2014-0035 CTRL
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
Thoracic Aortic Aneurysm
Obstructive Sleep Apnea
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Rupture
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Wounds and Injuries