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

NCT06012526 | Completed

• 1 other identifier: BeniSuefU MMSS
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea-hypopnea

Outcome Measures

Primary Outcomes (1)

• Measurements of apnea hypopnea index

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

  1and half years

Study Arms (2)

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

Polysomnography DIAGNOSTIC_TEST

Polysomnography is done for patients to find any sleep disordered breathing

Also known as: Sleep study

No OSA group; OSA group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni suef university

Banī Suwayf, Beni Suweif Governorate, Egypt

Location

MeSH Terms

Interventions

Polysomnography

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nabila Ebrahim Laz, Professor

  Head of chest department in BeniSuef university

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: November 25, 2020
• Primary Completion: April 20, 2022
• Study Completion: July 24, 2022
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)