Prevalence of OSA in Patients of ILD | NCT06058052

Studies
Prevalence of OSA in Patients of ILD

NCT06058052

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Sep 28, 2023Actual

Enrollment

81Estimated

Phase

Not provided

Conditions

Interventions

Not provided

Countries

Not provided

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 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2023Estimated

Primary Completion Date

Sep 28, 2024Estimated

Completion Date

Dec 25, 2024Estimated

First Submitted Date

Sep 22, 2023

First Submission Date that Met QC Criteria

Sep 22, 2023

First Posted Date

Sep 28, 2023Actual

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

Sep 22, 2023

Last Update Posted Date

Sep 28, 2023Actual

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

To evaluate the clinical predictors of OSA in patients with ILD

Detailed Description

Interstitial lung diseases (ILDs) are a group of heterogeneous disorders characterized by varying degrees of fibrosis and inflammation of lung parenchyma.

Obstructive sleep apnea is a type of sleep disordered breathing characterized by repeated episodes of apnea and hypopnea during sleep due to narrowing or occlusion of the upper airway.

It was found that the prevalence of OSA is as high as 80% among patients with idiopathic pulmonary fibrosis (IPF). Despite this common association, there is limited research in this field. There is great need for further studies to highlight this association and understand the underlying pathophysiological mechanisms implicated in those patients, to ultimately guide the appropriate management.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

81Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Predictors of OSA in patients with ILD	By clinical history ,examination, BMI	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of OSA among patients with ILD Presented To Chest Department in Assiut University Hospital	BY Polysomnography	base line

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients presented to Chest Department with interstitial lung disease will be included, screened for OSA.

Exclusion Criteria:

Age: less than 18 years. Unstable patients or need for ICU admission

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to Assiut University Hospital diagnosed as interstitial lung disease risky for OSA will be included from June 2023 to January 2024.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hend saleh, MD	Contact	01098988712		hend.m.saleh@gmail.com
Mohamed Khalaf, MD	Contact	01026600071		dr.mga2011@aun.edu.eg

Overall Officials

Name	Affiliation	Role
Mohamed yassen, MD	Assiut University	Study Chair

Locations

Not provided