A Study in People With Pulmonary Fibrosis to Monitor Cough With a Wearable Device
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- STATUS
- Recruiting
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- days left to enroll
- 82
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- participants needed
- 50
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- sponsor
- Boehringer Ingelheim
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.
Details
| Condition | Pulmonary Fibrosis |
|---|---|
| Treatment | A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection |
| Clinical Study Identifier | NCT05670587 |
| Sponsor | Boehringer Ingelheim |
| Last Modified on | 12 September 2023 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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