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

NCT ID: NCT06798688

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-07-01

Brief Summary

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.

Conditions

COPD

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

A non-invasive cardio-respiratory sensor will be applied on the subjects to measure parameters to identify exacerbations

This Study aims to pilot software algorithms based on respiratory features and hemodynamics for predicting exacerbations on a total of 20 participants with COPD. The end-points of this Study includes the following:

1. 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.

2. To validate level of compliance, drop-out rate and if additional measures are required to get participants to follow-on

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Respiree Pte Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Gurpreet Singh Singh

Role: CONTACT

gurpreet@respiree.com

6590617570

Other Identifiers

2025-001

Identifier Type: -

Identifier Source: org_study_id