Senti-REMAP-WEST-FLARE - Version 1.0
Research type
Research Study
Full title
Senti. Remote Evaluation and Monitoring of Acoustic Pathophysiological parameters With External Sensor Technology - FLAg for Review Efficacy investigation: a community-based comparative pivotal clinical investigation to validate a novel intelligent wearable medical device system for the autonomous monitoring and evaluation of acoustic pathophysiological parameters in order to determine clinical deterioration and flag deteriorating patients for clinical review, reducing time-to-intervention in respiratory disease flareups.
IRAS ID
324620
Contact name
Philip Alton
Contact email
Sponsor organisation
Senti Tech Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 25 days
Research summary
This clinical investigation seeks to validate whether or not the Senti-Wear device system with the Senti-AI subsystem is effective for autonomously monitoring people with long-term respiratory illness. The aim of this autonomous monitoring is to generate flags for review (FLARES) if the system detects a worsening (deterioration) in lung sounds which might indicate a worsening respiratory illness.
If effective, this device system will enable people with long-term respiratory illnesses to receive earlier intervention in disease flare-ups, ensuring these patients are on the right medication at the right time, avoiding hospital admissions, and staying well at home.
200 patients with COPD, Asthma, Bronchiectasis, or Cystic Fibrosis will be recruited. The design of this study is comparative. All 200 participants will undertake patient-sought care as usual, where patients seek medical aid once starting to feel more unwell. Over a six-month period, we will collect data on what care is sought and when this changes treatment. Participants will also use the Senti-Wear device to capture their breath and heart sounds twice a day over this six-month period. Participants, clinicians, and the research team will be blinded to the device output FLARES until the end of the data collection period.
At the end of the data collection period, we will compare this with Senti-AI FLARES, to determine whether acting on FLARES would have led to early intervention in disease flareups.
The study activities will take place in the participants' own homes. The study will recruit around Manchester and Liverpool, UK. The study is being funded by Senti-Tech limited, the manufacturer of the Senti-Wear with Senti-AI device system.
REC name
North East - York Research Ethics Committee
REC reference
23/NE/0065
Date of REC Opinion
20 Apr 2023
REC opinion
Favourable Opinion