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

NCT05670587 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-03-11

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2024-02-22
Completion
2024-03-07
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05670587 on ClinicalTrials.gov