Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Respiratory Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: A pilot stage, exploratory, First-In-Human and traditional feasibility, interventional study of the Senti V1.0 device (CE marked, Class I device), involving 10 patients attending A&E, who are being discharged into the care of the community respiratory team. 5 devices will be used, to cover a range of sizes from extra-small to extra-large.Masking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
TITLE: Remote Evaluation and Monitoring of Acoustic Pathophysiological parameters with external sensor technology. DESIGN: First-In-Man and Feasibility study of the Senti Version 1 Device. AIMS: To explore the acceptability and feasibility of a novel medical device for the remote monitoring and eval...
TITLE: Remote Evaluation and Monitoring of Acoustic Pathophysiological parameters with external sensor technology. DESIGN: First-In-Man and Feasibility study of the Senti Version 1 Device. AIMS: To explore the acceptability and feasibility of a novel medical device for the remote monitoring and evaluation of acoustic pathophysiological parameters. - To investigate usability and acceptability of the Senti data capture device, and to ensure technical and practical functionality of the device in a real-world clinical scenario. PRIMARY OUTCOMES: Device feasibility SECONDARY OUTCOMES: Length of time with the device in situ. The ease with which patients can apply the device. POPULATION ELIGIBILITY: Patients being discharged home with community respiratory team support, after attending A&E. DURATION: 3 Months. (Recruitment period: 2 months. Analysis and reporting: 1 month).
Tracking Information
- NCT #
- NCT04693091
- Collaborators
- Not Provided
- Investigators
- Not Provided
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