Obstructive Sleep Apnoea in Adolescents With Thoracic Aor... | NCT03400319

Studies
Obstructive Sleep Apnoea in Adolescents With Thoracic Aortic Aneurysm

NCT03400319

Sponsor

University of Zurich

Status

Completed

Last Update Posted

May 3, 2021Actual

Enrollment

174Actual

Phase

Not provided

Conditions

Thoracic Aortic Aneurysm Without Rupture
Obstructive Sleep Apnea

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 5, 2014Actual

Primary Completion Date

Mar 1, 2020Actual

Completion Date

Mar 1, 2020Actual

First Submitted Date

Jan 9, 2018

First Submission Date that Met QC Criteria

Jan 9, 2018

First Posted Date

Jan 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2021

Last Update Posted Date

May 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

174Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of Obstructive Sleep Apnea	Prevalence of Obstructive Sleep Apnea according to a Sleep study (The ApneaLink™)	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with and without Thoracic Aortic Aneurysm

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Pulmonary Division		Zurich		8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D017545	Aortic Aneurysm, Thoracic

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided