NCT06503757

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

July 20, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 10, 2024

Last Update Submit

July 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • the prevalence of misinterpretation of interstitial lung disease (ILD) on high-resolution computed tomography (HRCT) scans in obese patients with obstructive sleep apnea (OSA).

    determined by assessing the agreement between radiologists' interpretations of HRCT findings related to ILD in this specific patient population.

    Baseline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 33561604BACKGROUND
  • 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.

    PMID: 32701670BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 16, 2024

Study Start

July 20, 2024

Primary Completion

December 20, 2024

Study Completion

January 20, 2025

Last Updated

July 16, 2024

Record last verified: 2024-07