In This Study, the Sponsor Would Like to Collaborate with Institution and Investigator to Aggregate Participants Data and to Pilot Its Software Algorithm Using Machine Learning and Threshold Based Methods for Predicting Exacerbations and Deterioration Within a 60 Days Period Post-discharge

Software Algorithm Using Machine Learning and Threshold Based Methods for Predicting Exacerbations and Deterioration

In this study, the sponsor would like to collaborate with Institution and Investigator to aggregate participants data and to pilot its software algorithm using machine learning and threshold based methods for predicting exacerbations and deterioration within a 60 days period post-discharge.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD
• Intervention / Treatment: Device: A non-invasive cardio-respiratory sensor will be applied on the subjects to measure parameters to identify exacerbations

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Gurpreet Singh Singh; Phone Number: 6590617570; Email: gurpreet@respiree.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The enrolment goal is 20 participants with at least 2 documented exacerbations in the past 12 months for a period of 8 weeks each. In addition to the baseline visit and Study on-boarding, there will be 2 follow-ups every month. Participants will be enrolled at discharge (and not designate hospital or ED).

Description

Inclusion Criteria:

1. Subject age 18 or older
2. Receives all primary and specialty care at Institution
3. Participants will be enrolled at discharge (and not designate hospital or ED)

4. A history of one of the following diagnoses:

   a. c. Chronic obstructive pulmonary disease

5. At least two documented exacerbations of the above disease in the past 12 months as defined by the following corresponding criteria:

   a. Chronic obstructive pulmonary disease exacerbation: all three of (1) increase in frequency and severity or severity of cough, (2) increase in volume and/or change of character of sputum production, and (3) increase in dyspnea, and requiring treatment with short-acting bronchodilators, antibiotics, and oral or intravenous glucocorticoids.

6. Participants able to provide informed consent.
7. Participants will be enrolled at discharge (and not designate hospital or ED)

Exclusion Criteria:

1. Participants with neuromuscular diseases and seizures
2. Participants enrolled in hospice care or life expectancy less than three months.
3. Participants living more than 60 miles away from Institution and Investigator
4. Participants with expected out of state travel within a 30-day period or travel to a location with no internet access.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identifying readmissions using respiratory biomarkers	To validate respiratory-based biomarkers in models to predict exacerbations - benchmarking to be done versus physician assess exacerbations, emergency department visits, hospitalizations and any other visit.	60-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validate compliance and usability	To validate level of usability using self-assessed questionnaires required to get participants to follow-on	60-days

Collaborators and Investigators

• Sponsor: Respiree Pte Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2025-001 (Oblastní nemocnice Kolín a.s.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes