ILD In Obese Patients With OSA

July 10, 2024 updated by: Hend Mohamed Sayed Mohamed, Assiut University

Misinterpretation of ILD In Obese Patients With OSA

Assess the impact of obesity and OSA on the interpretation of high-resolution computed tomography (HRCT) findings in patients with ILD.

Identify specific challenges or confounding factors that may contribute to the misinterpretation of HRCT findings in this population.

Evaluate the potential consequences of misinterpretation, including delayed or inaccurate diagnosis, inappropriate treatment decisions, and suboptimal patient outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Obesity and obstructive sleep apnea (OSA) can lead to radiographic findings on HRCT that may be mistaken for interstitial lung disease (ILD) The increased adipose tissue deposition and altered lung mechanics associated with obesity, as well as the chronic intermittent hypoxia seen in OSA, can result in HRCT changes such as ground-glass opacities, septal thickening, and reduced lung volumes .

Several studies have highlighted the potential for misdiagnosis of ILD in obese patients with OSA. A retrospective analysis by Washko et al. found that 32% of obese individuals with suspected ILD were subsequently reclassified as having changes related to obesity and OSA rather than true interstitial lung disease Similarly, a study by Patel et al. reported that 27% of patients referred for evaluation of suspected ILD were found to have findings attributable to obesity and OSA rather than an underlying interstitial lung process

The accurate differentiation between ILD and the HRCT changes associated with obesity and OSA is crucial, as the management strategies for these conditions differ significantly. Misdiagnosis can lead to unnecessary and potentially harmful treatments, as well as delayed recognition and management of the underlying obesity and OSA .

Therefore, a comprehensive clinical evaluation, including assessment of body mass index, sleep study findings, and consideration of the full clinical context, is essential to correctly distinguish between ILD and the radiographic changes seen in obese patients with OSA

Study Type

Observational

Enrollment (Estimated)

94

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

Probability Sample

Study Population

collect relevant demographic and clinical data, including age, gender, BMI, OSA severity, ILD subtype (if available), pulmonary function test results, and details of previous treatments.

2. HRCT Scans: HRCT images of the selected patients will be retrieved from the Picture Archiving and Communication System (PACS) or electronic medical record system.

1. Radiological Assessment: will independently review the HRCT scans. They will assess the presence and extent of ILD, evaluate the specific radiological patterns (e.g., ground-glass opacities, reticular opacities, honeycombing), and record any other notable findings.

Description

Inclusion Criteria:

  • Presence of obesity, defined by body mass index (BMI) ≥30 kg/m².
  • Confirmed diagnosis of OSA based on polysomnography
  • Availability of HRCT scans for analysis

Exclusion Criteria:

  • OSA in non obese patients
  • History of lung surgery or lung transplantation.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the prevalence of misinterpretation of interstitial lung disease (ILD) on high-resolution computed tomography (HRCT) scans in obese patients with obstructive sleep apnea (OSA).
Time Frame: Baseline
determined by assessing the agreement between radiologists' interpretations of HRCT findings related to ILD in this specific patient population.
Baseline

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Estimated)

July 20, 2024

Primary Completion (Estimated)

December 20, 2024

Study Completion (Estimated)

January 20, 2025

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ILD &OSA

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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