NCT06156462

A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Adolescent and Adult Patients in an Emergency Department

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 171 (actual)
• Sponsor: ResApp Health Limited · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: —

Summary

Aim is to to demonstrate that the ResAppDx v2.0 algorithms provide an accurate diagnosis of respiratory disease in the study's clinical setting compared to a clinical adjudication committee's (CAC) diagnosis; and to establish a baseline for the resource use and cost of current care pathways for respiratory disease diagnosis in an emergency department. Eligible subjects will be consented/enrolled and their subject reported signs/symptoms of respiratory disease will be recorded in the study electronic case report form (eCRF). The enrolled subject's cough sounds will be captured (5 cough sounds are required) using the ResAppDx v2.0 Investigational Device (ID) software installed on a study smartphone; cough sounds may be voluntary and/or involuntary/spontaneous. As this is an observational study the treating team will be blinded to the ResAppDx v2.0 diagnoses. Additional medical information will be collected from the treating team, from the subject and from the subject's medical record. No follow-up/subsequent visits with the subject will be required by the study. As an efficacy comparator, a clinical adjudication committee (CAC) will determine the final clinical diagnosis using the disease case definitions, eCRF data and the subject's medical record. Information on time and scope of tests and consults ordered by the treating team will be recorded to set a baseline for resource use and cost of current standard of care treatment/assessment procedures. This data will allow future health economics analyses to be performed. The blinded ResAppDx v2.0 diagnoses will be unblinded after database lock and sensitivity and specificity will be calculated for the ResAppDx v2.0 diagnoses compared to agreement with the CAC's final clinical diagnoses.

Conditions

• Asthma Exacerbation
• COPD Exacerbation
• Lower Respiratory Disease
• Pneumonia

Interventions

Type	Name	Description
DEVICE	ResAppDx v.20	Software device measuring cough sounds to aid diagnosis of respiratory diseases

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2023-12-05
• Last updated: 2024-03-04

Locations

3 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated device study