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

Respiree

Status: Not yet enrolling

Conditions: COPD

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

Study type: Observational

Funder types: Industry

Identifiers

NCT06798688

2025-001

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.