- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06503757
ILD In Obese Patients With OSA
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
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
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
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
Sponsor
Publications and helpful links
General Publications
- Khor YH, Ryerson CJ, Landry SA, Howard ME, Churchward TJ, Edwards BA, Hamilton GS, Joosten SA. Interstitial lung disease and obstructive sleep apnea. Sleep Med Rev. 2021 Aug;58:101442. doi: 10.1016/j.smrv.2021.101442. Epub 2021 Jan 22.
- Schiza SE, Bouloukaki I, Bolaki M, Antoniou KM. Obstructive sleep apnea in pulmonary fibrosis. Curr Opin Pulm Med. 2020 Sep;26(5):443-448. doi: 10.1097/MCP.0000000000000697.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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