A Study in People With Pulmonary Fibrosis to Monitor Cough With a Wearable Device
- Conditions
- Pulmonary Fibrosis
- Interventions
- Device: A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection
- Registration Number
- NCT05670587
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All participants A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection -
- Primary Outcome Measures
Name Time Method Cough Count Per Hour (CC/hr) Measured Over a 24-hour Period at Baseline Visit, Week 4, Week 8, and at Day 82 At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6). Cough count per hour (CC/hr) measured over a 24-hour period at baseline visit, Week 4, Week 8, and at Day 82.
- Secondary Outcome Measures
Name Time Method Change From Baseline (CfB) in Cough Count Per Hour (CC/h) at Week 4, Week 8 and at Day 82 At baseline (Visit 2), Week 4, (Visit 4) Week 8 (Visit 5) and at Day 82 (Visit 6). Change from baseline (CfB) in cough count per hour (CC/h) at Week 4, Week 8 and at Day 82. Cough count per hour (CC/h) was measured over a 24-h period.
Forced Vital Capacity (FVC) at Baseline and at Week 12 At baseline (Visit 2) and at Week 12 (Visit 7). Forced Vital Capacity (FVC) at baseline and at Week 12.
Change From Baseline in Forced Vital Capacity (FVC) at Week 12 At baseline (Visit 2) and at Week 12 (Visit 7). Change from baseline in Forced Vital Capacity (FVC) at Week 12.
Percentage (%) of Analysable Cough Device Data Per 24-hour Recording (Feasibility of Remote Cough Data Capture) At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6). Feasibility of remote cough data capture , defined as % of analysable cough device data per 24-hours recording.
The percentage of analysable data per 24-hours recording period was derived from cough count (CC) recording times (total readable recording time) and defined as:
(Total readable recording time/24 hours)·100 Percent of analysable cough data is percentage of 24 hours of total expected recording time that was readable.Number of Successful Completion of All Elements of Remote Visit (Feasibility of Hybrid Study Design) At Day 3 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6). Successful completion of all elements of remote visit (feasibility of hybrid study design). Successful completion of a remote visit was based on the questions on the home trial procedures:
* Was home spirometry performed?
* Was the video conference tele-visit completed?
* Was the 24-hour cough recording completed? The number (percentage) of participants who completed each element is reported by visit.
Trial Locations
- Locations (13)
Kortrijk - HOSP AZ Groeninge Kennedylaan
🇧🇪Kortrijk, Belgium
Critical Care, Pulmonary and Sleep Associates
🇺🇸Lakewood, Colorado, United States
Southeastern Research Center
🇺🇸Winston-Salem, North Carolina, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
Lowcountry Lung and Critical Care
🇺🇸Charleston, South Carolina, United States
Aalst - HOSP Onze-Lieve-Vrouw
🇧🇪Aalst, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
🇧🇪Hasselt, Belgium
Roeselare - HOSP AZ Delta
🇧🇪Roeselare, Belgium
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands