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Trial record 12 of 101 for:    "thoracic aortic aneurysms and aortic dissections" OR "Aortic Aneurysm, Thoracic"

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

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ClinicalTrials.gov Identifier: NCT03400319
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
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.

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 : January 1, 2019
Estimated Study Completion Date : June 1, 2019


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™)



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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
Switzerland
University Hospital Zurich, Pulmonary Division Recruiting
Zurich, Switzerland, 8091
Contact: Thomas Gaisl, MD    +41 44 255 4947    thomas.gaisl@usz.ch   
Principal Investigator: Malcolm Kohler, Prof         
Sub-Investigator: Thomas Gaisl, MD         
Sponsors and Collaborators
University of Zurich

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03400319     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2014-0035 CTRL
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Aortic Aneurysm, Thoracic
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Aneurysm
Aortic Aneurysm
Rupture
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Wounds and Injuries