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

NCT06798688 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025-001
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Validate compliance and usability

  60-days

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Subject age 18 or older
• Receives all primary and specialty care at Institution
• Participants will be enrolled at discharge (and not designate hospital or ED)
• A history of one of the following diagnoses:
• a. c. Chronic obstructive pulmonary disease
• 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.
• Participants able to provide informed consent.
• Participants will be enrolled at discharge (and not designate hospital or ED)

You may not qualify if:

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

Sponsors & Collaborators

• Respiree Pte Ltd: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gurpreet Singh Singh

CONTACT

6590617570; gurpreet@respiree.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 29, 2025
• Study Start: March 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share