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

August 24, 2023 updated by: Mona Mahmoud Srour Soliman, Beni-Suef University

Study of the Prevalence and Predictive Factors of Sleep Disordered Breathing in Patients With Interstitial Lung Diseases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Beni Suef
      • Banī Suwayf, Beni Suef, Egypt
        • Beni suef university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OSA group
The group of patients who had sleep disordered breathing
Diagnostic test: Polysomnography
Polysomnography is done for patients to find any sleep disordered breathing
Other Names:
  • Sleep study
No OSA group
The group of patients who had not sleep disordered breathing
Diagnostic test: Polysomnography
Polysomnography is done for patients to find any sleep disordered breathing
Other Names:
  • Sleep study

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Study Chair: Nabila Ebrahim Laz, Professor, Head of chest department in BeniSuef university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2020

Primary Completion (Actual)

April 20, 2022

Study Completion (Actual)

July 24, 2022

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeniSuefU MMSS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

E mail address only can be shared

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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