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

Obstructive Sleep Apnea-hypopnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06012526
• Other study ID #: BeniSuefU MMSS
• Status: Completed
• Start date: November 25, 2020
• Est. completion date: July 24, 2022

Study information

• Verified date: August 2023
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 24, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial
• Obstructive Sleep Apnea-hypopnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Polysomnography
Polysomnography is done for patients to find any sleep disordered breathing

Locations

Country	Name	City	State
Egypt	Beni suef university	Bani Suwayf	Beni Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of apnea hypopnea index	Polysomnography can measure apnea hypopnea index of all patients to detect sleep disordered breathing	1and half years