Recruiting

Observational Study

Sponsor:

Institute of Bioengineering and Bioimaging (IBB)

Code:

NCT04825067

Conditions

Congestive Heart Failure

Asthma

Chronic Obstructive Pulmonary Disease

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Respiratory Sensor measurements

Study Details

Brief summary:

In this project, Institute of Bioengineering \& Bioimaging (IBB), A\*STAR would like to collaborate with Massachusetts General Hospital to aggregate patient data and to further develop its software algorithm using machine learning and statistical models for predicting exacerbations and deterioration on 60 patients with cardiopulmonary diseases.

Conditions

Congestive Heart Failure

Asthma

Chronic Obstructive Pulmonary Disease

Cystic Fibrosis

Study ID

NCT04825067

Start date

Apr 1, 2022

Status verified date

Sep, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subject age 18 or older
2. Receives all primary and specialty care within the MassGeneral Brigham system
3. A history of one of the following diagnoses:

1. Asthma
2. Cystic Fibrosis
3. Chronic obstructive pulmonary disease
4. Congestive heart failure
4. At least four documented exacerbations of the above disease in the past 12 months as defined by the following corresponding criteria:

a. Asthma exacerbation: i. a minimum 3-day course of oral steroids ii. for patients on chronic steroids, an increased dose of steroids.

b. Cystic fibrosis exacerbation: a minimum 7-day course of systemic antibiotics (not including any chronic suppressive antibiotics).

c. 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.

d. Congestive heart failure exacerbation: volume overload (as evidenced by weight gain or elevated BNP \[>100 pg/mL\]/NT-proBNP \[>300 pg/mL)) plus dyspnea plus diuretic treatment (new or increase from baseline).
5. Subject able to provide informed consent.

Exclusion Criteria:

1. Subjects with a history of adhesive or tape allergy or skin reaction.
2. Subjects with pacemaker, Automatic Implantable Cardioverter Defibrillator (AICD) and other implantable electronic devices.
3. Subjects with neuromuscular disease, seizures and/or Parkinson's disease.
4. Subjects with expected out of state travel within a 90-day period or travel to a location with no internet access.
5. Subjects enrolled in hospice care or life expectancy less than three months.
6. Subjects living more than 60 miles away from Massachusetts General Hospital. -

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Respiratory Sensor measurements

The participant will receive 2 Respiratory Sensors and 1 gateway with wireless compatibility and a welcome packet with instructions for use, a reminder description of the study purpose and procedures, and research staff contact information. Research staff will contact participants to ensure appropriate setup of the Respiratory Sensor and training on proper use. Research staff will ask the subject to place the Respiratory Sensor on the top left-side of the chest. The Respiratory Sensor continuously collects and monitors respiratory data. The participant will be instructed to change each Respiratory Sensor after 24-48 hours. Subjects will be asked to charge each Respiratory Sensor once it is removed. Subjects will exit the study upon completion of the 90-day follow-up.

Interventions

Respiratory Sensor measurements

The participant will receive 2 Respiratory Sensors and 1 gateway with wireless compatibility and a welcome packet with instructions for use, a reminder description of the study purpose and procedures, and research staff contact information. Research staff will contact participants to ensure appropriate setup of the Respiratory Sensor and training on proper use. Research staff will ask the subject to place the Respiratory Sensor on the top left-side of the chest. The Respiratory Sensor continuously collects and monitors respiratory data. The participant will be instructed to change each Respiratory Sensor after 24-48 hours. Subjects will be asked to charge each Respiratory Sensor once it is removed. Subjects will exit the study upon completion of the 90-day follow-up.

Primary outcome measure

  • Respiratory rate (no. of breaths per minute) [ Time Frame: 90 days ]
  • Depth of breathing [ Time Frame: 90 days ]
  • Inhalation/exhalation times [ Time Frame: 90 days ]
  • Heart rate [ Time Frame: 90 days ]
  • Tissue oxygen saturation [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Locations

Integrated Care Management Program

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

More Information

Sponsor

Institute of Bioengineering and Bioimaging (IBB)

Last update posted

Sep 29, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Institute of Bioengineering and Bioimaging (IBB) on 2022-09-29.