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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06798688

Enrollment

Registered

2025-01-29

Start date

2025-03-01

Completion date

2025-07-01

Last updated

2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

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.

Interventions

DEVICEA 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

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Identifying readmissions using respiratory biomarkers	60-days	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.

Secondary

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

Contacts

Primary ContactGurpreet Singh Singh

gurpreet@respiree.com6590617570

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026