Your session is about to expire
← Back to Search
Behavioural Intervention
Wearable Cough Monitor for Pulmonary Fibrosis
N/A
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject diagnosed with Non-Idiopathic Pulmonary Fibrosis (IPF) Pulmonary Fibrosis (>10% fibrosis on High Resolution Computed Tomography (HRCT) by principal investigator assessment) or IPF as per American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Asociación Latinoamericana de Tórax (ATS/ERS/JRS/ALAT) Guidelines within the past 12 months
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
Study Summary
This trial is looking at coughing in people with pulmonary fibrosis using a wearable monitor. Participants will have visits at the study site and at home to monitor their health, coughing and lung function.
Who is the study for?
Adults over 18 with pulmonary fibrosis can join this study if they have a lung function (FVC) above 40%, haven't had respiratory infections or changed cough medications in the last month, and aren't current smokers. They should not have other major lung conditions or be on certain treatments for lung issues.Check my eligibility
What is being tested?
The trial is testing a wearable cough monitor called Strados RESP sensor to track coughing patterns in pulmonary fibrosis patients. Participants wear the device for three months, attend clinic visits, complete questionnaires, and undergo regular health checks including lung function tests.See study design
What are the potential side effects?
Since this trial involves monitoring with a wearable device rather than medication, there are no direct side effects from drugs. However, participants may experience discomfort or skin irritation where the device is attached.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Pulmonary Fibrosis or IPF in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cough count per hour (CC/hr) measured over a 24-hour period at baseline visit, Week 4, Week 8, and Week 12.
Secondary outcome measures
Change from baseline in CC/hr at Week 4, Week 8, Week 12.
Change from baseline in FVC (mL) at Week 12
FVC (mL) at Week 12
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection
2023
N/A
~60
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,340,239 Total Patients Enrolled
60 Trials studying Pulmonary Fibrosis
46,944 Patients Enrolled for Pulmonary Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a cold, flu, or COVID-19 in the last 4 weeks.Your lung function is not too low, it's at least 40% of what's expected for someone your age and size.I have breathing issues with less than 70% normal airflow.My cough is not caused by interstitial lung disease.I haven't started or changed any cough, ACE inhibitors, opiates, or steroid medications in the last 4 weeks.I have had a worsening of my lung condition in the last 4 weeks.I have been diagnosed with Pulmonary Fibrosis or IPF in the last year.You are currently a smoker.I am 18 years old or older.Your doctor thinks you will live for at least 6 more months.I do not have any significant lung problems like COPD, asthma, or lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: All participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants being enrolled at this time in the experiment?
"Per the clinicaltrials.gov website, this research is presently recruiting participants. It was initially made available on January 16th 2023 and its latest update occurred on April 5th 2023."
Answered by AI
How many individuals are receiving treatment through this experimental protocol?
"Absolutely. According to clinicaltrials.gov, this experiment is currently looking for volunteers; it was initially posted on January 16th 2023 and recently updated on April 5th 2023. The study requires 50 participants that are recruited from five distinct locations."
Answered by AI
How many different sites are engaged with this experimental endeavor?
"Currently accepting participants, this clinical trial is recruiting patients from 5 sites situated in and around Kortrijk, Roeselare, Aalst as well as a couple other locales. Choosing the closest clinic to you can help curtail travel needs if opting into this medical experiment."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger