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Remote Monitoring in Preschool Wheeze

NCT05447832 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-07-07

No results posted yet for this study

Summary

The aim of this project is to fill the significant unmet healthcare need to prevent wheeze attacks in preschool children. This will be achieved by developing a proof-of-concept, bespoke home remote objective monitoring system for preschool children that can identify early signs before a wheeze attack to allow early intervention and prevention. This study aims to develop methods for recognising child-specific abnormal patterns in time-course lung function data, and wheeze onset providing early warning of deterioration. The prototype system is targeted for use by caregivers of preschool children with wheeze, and will integrate the individual child's information about symptoms, medication use and lung function to alert parents to seek healthcare advice to prevent hospitalisation.

Conditions

  • Wheezing
  • Respiratory Sounds

Interventions

DEVICE

Lung function monitoring equipment at home - 2 weeks

The parent/carer setup the lung function monitoring equipment (Ventica®), and placed the WheezeScan® device on the child's chest at home before the child goes to sleep. This is performed once daily for 2 weeks.

DEVICE

Lung function monitoring equipment at home - 4 months

The parent/carer setup the lung function monitoring equipment (Ventica®), and placed the WheezeScan® device on the child's chest at home before the child goes to sleep. This is performed once weekly for 4 months.

DIAGNOSTIC_TEST

Inflammation and remodelling from clinical indicted bronchoscopy

For patients who are undergoing clinically indicated bronchoscopy, consent will be obtained to use any surplus clinical samples for this study. The samples to be collected are broncho-alveolar lavage and endobronchial biopsies. Both of these are taken from the airways during clinical bronchoscopy.

Sponsors & Collaborators

  • Engineering and Physical Sciences Research Council, UK

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Sejal Saglani, MD · Imperial College London

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-11-29
Completion
2024-03-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05447832 on ClinicalTrials.gov