NCT05670587

A Study in People With Pulmonary Fibrosis to Monitor Cough With a Wearable Device

A Multi-center, Longitudinal 12-week Pilot Study to Evaluate Cough Severity and Its Impact, Utilizing a Next Generation Cough Monitor, in Participants With Idiopathic Pulmonary Fibrosis (IPF) or Non IPF Pulmonary Fibrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults aged 18 years and older who have pulmonary fibrosis with or without a known cause (or other forms of pulmonary fibrosis). The purpose of this study is to better understand coughing in people with pulmonary fibrosis. To do this, a wearable cough monitor called Strados Remote Electronic Stethoscope Platform (RESP) is used. This device will measure how often and how forceful coughing is in people with pulmonary fibrosis. All participants in the study get the device. It is placed on their skin over the chest. Participants are in the study for 3 months. During this time, they visit the study site 2 to 3 times. 4 visits are done at the participant's home by video call with the site staff. During the study, the device measures coughing over 24 hours. This is done on 4 days. Participants fill in questionnaires about their coughing and doctors regularly check participant's lung function. A breathing test that measures how well the lungs are working is performed both in the office and during home visits. The doctors also regularly check participants' health and take note of any unwanted effects. This study will also record patients' experiences using the cough monitor and video assisted breathing tests at visits 3, 4, 5 and 6 at home.

Conditions

• Pulmonary Fibrosis

Interventions

Type	Name	Description
DEVICE	A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection	A wearable cough monitoring device, the Strados Labs Remote Electronic Stethoscope Platform (RESP)ᵀᴹ sensor, with an accompanying mobile application (App) for data collection.

Timeline

• Start date: 2023-01-16
• Primary completion: 2024-02-22
• Completion: 2024-03-07
• First posted: 2023-01-04
• Last updated: 2025-03-11
• Results posted: 2025-03-11

Locations

13 sites across 4 countries: United States, Belgium, Germany, Netherlands

Regulatory

• FDA-regulated device study