The Study of Sleep Disordered Breathing in Patients With... | NCT06012526

Studies
The Study of Sleep Disordered Breathing in Patients With Interstitial Lung Diseases

NCT06012526

Sponsor

Beni-Suef University

Status

Completed

Last Update Posted

Aug 25, 2023Actual

Enrollment

69Actual

Phase

Not provided

Conditions

Obstructive Sleep Apnea-hypopnea

Interventions

Polysomnography

Countries

Egypt

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

Aug 2023

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

Nov 25, 2020Actual

Primary Completion Date

Apr 20, 2022Actual

Completion Date

Jul 24, 2022Actual

First Submitted Date

Aug 21, 2023

First Submission Date that Met QC Criteria

Aug 24, 2023

First Posted Date

Aug 25, 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

Aug 24, 2023

Last Update Posted Date

Aug 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This was a cross-sectional observational study to evaluate the prevalence and predictive factors of SDB in ILD and to analyze the relationship between polysomnography (PSG) findings, pulmonary function, disease severity, parenchymal involvement, and sleep questionnaires ESS and SBQ. This study included 69 patients who were diagnosed with diffuse parenchymal lung diseases by high-resolution computed tomography (HRCT) chest. All patients were subjected to clinical examination, HRCT, spirometry, full-night polysomnography, and echocardiography.

Detailed Description

Not provided

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

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OSA group		The group of patients who had sleep disordered breathing	Diagnostic Test: Polysomnography
No OSA group		The group of patients who had not sleep disordered breathing	Diagnostic Test: Polysomnography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polysomnography	Diagnostic Test	Polysomnography is done for patients to find any sleep disordered breathing	No OSA group OSA group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurements of apnea hypopnea index	Polysomnography can measure apnea hypopnea index of all patients to detect sleep disordered breathing	1and half years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Both sexes of clinically stable ILD patients older than 18 who met the ATS/ERS criteria for an ILD diagnosis were included in the study.

Exclusion Criteria:

Patients who have any anatomic upper airway obstructions such as significant nasal septal deviation, nasal polyps, conchae hypertrophy or tonsillar hypertrophy.
Patients with neurological diseases or severe psychiatric disorders.
Patients who have history of administration of any drug that has a major effect on sleep e.g. benzodiazepine, narcotic drugs ….etc.
Patients with any chronic pulmonary disease except ILD.
Total sleep time less than 4 hours on PSG.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

69 patients with interstitial lung diseases of both sexs and older than 18 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nabila Ebrahim Laz, Professor	Head of chest department in BeniSuef university	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beni suef university		Banī Suwayf	Beni Suweif Governorate		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

E mail address only can be shared

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017286	Polysomnography

Ancestor Terms

ID	Term
D008991	Monitoring, Physiologic
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

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