An interventional study of SenseGuard monitoring in Asthma, sponsored by NanoVation. Completed at 1 site in Cyprus. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-26.
Sponsored by NanoVation · Not applicable, Interventional, and Diagnostic
SenseGuard (SG) is an innovative device for respiratory monitoring. At this study SG measurement will be integrated in a Methacholine Challenge Test (MCT) for monitoring changes in airway obstruction occurred during MCT in parallel to spirometry.
SenseGuard (SG) is a wireless wearable medical device intended for monitoring of patient's breathing. It allows to seamlessly monitor patient's tidal breathing, at rest or during daily activities, and to extract critical respiratory parameters, such as respiration rate (RR) and durations, ratios and variability of phases within the breath-cycle, including: inspired breath (Ti) and expired breath (Te).
The study goal is to evaluate the capability of SG to measure clinical changes in respiratory parameters.
During Methacholine Challenge Test (MCT), asthma patients demonstrate airway responsiveness due to airway obstruction. SG will be used to measure respiratory parameters during MCT in parallel to spirometry and the correlation between measurable respiratory parameters will be assessed.
Successful study results will demonstrate the capability of SG to measure changes in airway obstruction leading to future implementation of SG for monitoring of patients with respiratory diseases and improvement of their clinical outcome.
NanoVation is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects who have known contradictions to MCT, including:
Subjects with suspected diagnosis of Asthma and eligible for MCT will be recruited to the study. The MCT procedure will be performed as usual, with the addition of SG measurements after each spirometry for each Methacholine dose.
Device: SenseGuard monitoring
All subjects that recruited to the study will undergo MCT as usual with the addition of SG measurement after each Methacholine dose and spirometry test.
Respiratory parameters (Inhalation and Exhalation time and ratio) measured by SG during MCT can indicate for changes in airway obstruction occurred in positive MCT
SG respiratory parameters(Inhalation and Exhalation (I/E) time and ratio), can measure successfully changes in respiratory parameters during MCT procedure, in at least of 70% of the subjects with MCT positive result (FEV1 \< 20% of predicted FEV1).
Time frame: 6 months
SG respiratory parameters (Inhalation and Exhalation time and ratio) are in correlation with Spirometry values (FEV1) obtained during MCT
There is at least 70% correlation between changes in respiratory parameters measured by SG (Inhalation and Exhalation (I/E) time and ratio),and by Spirometry values (%FEV1 reduced from baseline) for at least 70% of subjects participating in the study.
Time frame: 6 months
Plan to share: Yes
Supporting information: Study protocol, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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