A Feasibility Study of Wearable Device in Assessing Respiratory Condition Change of Patients With Exacerbation of COPD

NanoVation Therapeutics (NTx)

Status: Completed

Conditions: COPD Exacerbation

Treatments: Device: SenseGuard

Study type: Interventional

Funder types: Industry

Identifiers

NCT05153122

CIV-19-07-029227

Details and patient eligibility

About

The study will include daily SenseGuard measurement of patients hospitalized with exacerbations of COPD. from admission to discharge. In parallel clinical evaluation of patient's respiratory condition was done daily by routine tests and questionnaires.

Full description

A study for evaluating the feasibility of SenseGuard in assessing the respiratory condition change of hospitalized patients with exacerbation of COPD, by monitoring respiratory parameters. The study duration for each patient will start at the time of enrollment until the patient is released, or until the optional post-discharge follow-up visit.

The study will include at least one visit per day: The visit and measurement with SenseGuard will start prior to the first medical exacerbation treatment effect-onset given on each study day (by inhalation or IV). The measurement with SenseGuard will be done before and after treatment.

At the investigator discretion, additional two similar visits could be performed on the same study day, with or without the admission of the medical exacerbation treatment.

During the study, both the investigator and the patients will be asked to fill questionnaires to assess the patient's condition Additionally, measurements that are performed and collected as a standard practice or at the request of the medical personnel as part of patient's treatment course shall be documented and used as a reference for the study device assessment.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Primary or secondary diagnosis of AECOPD (Acute Exacerbation of Chronic Obstructive Pulmonary Disease) in patients with GOLD 1-4/A-D
2. WHO performance status ≤ 3
3. Provision of signed and dated informed consent form.
4. Male or female, aged ≥18.
5. Ability and stated willingness to adhere to the study regimen and availability for the duration of the study.

Exclusion criteria

3. Inability to provide informed consent including patients still impacted by the use of narcotics as part of emergency care.

4. Intubated patients or patients undergoing a BIPAP/CPAP/NHF treatment and are medically not able to suspend the treatment for the required duration of the visits or expected intolerance of the sensor in their face due to severe respiratory distress.

5. Presence of implanted electronic device intended to regulate cardiac activity (e.g., pacemaker or cardioverter/defibrillator).

6. Pregnancy or lactation. 7. Known allergic reactions to materials used in the components of the SenseGuard™ system, i.e. polyethylene or silicon, or gold, nickel, copper or alloys containing any of the above.

7. Participation in another study that is related to treatment of the respiratory condition.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Investigational SenseGuard Device

Experimental group

Description:

Patients undergo SG monitoring at least twice daily before and after receiving treatment.

Treatment:

Device: SenseGuard