Clincosm LogoSign in Get a demo

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

Sponsor
Beni-Suef University (Other)
Overall Status
Completed
CT.gov ID
NCT06012526
Collaborator
(none)
69
Enrollment
1
Location
19.9
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Polysomnography

Study Design

Study Type:
Observational
Actual Enrollment :
69 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Study of the Prevalence and Predictive Factors of Sleep Disordered Breathing in Patients With Interstitial Lung Diseases
Actual Study Start Date :
Nov 25, 2020
Actual Primary Completion Date :
Apr 20, 2022
Actual Study Completion Date :
Jul 24, 2022

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measurements of apnea hypopnea index [1and half years]

      Polysomnography can measure apnea hypopnea index of all patients to detect sleep disordered breathing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beni suef university Banī Suwayf Beni Suef Egypt

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mona Mahmoud Srour Soliman, Assistant lecturer, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT06012526
    Other Study ID Numbers:
    • BeniSuefU MMSS
    First Posted:
    Aug 25, 2023
    Last Update Posted:
    Aug 25, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive
    Lung Diseases
    Lung Diseases, Interstitial

    Study Results

    No Results Posted as of Aug 25, 2023