A Feasibility Study of SenseGuard to Assess Airway Responsiveness During Methacholine Challenge Test (MCT)

A Feasibility Study of a Non-Invasive Wearable Device in Assessing Airway Responsiveness Related Parameters During Methacholine Challenge Test (MCT)

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: SenseGuard monitoring

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Nicosia, Cyprus
    • Nicosia Lung Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, aged ≥18.
• Eligible for MCT procedure. The contradictions to MCT are listed as exclusion criteria.
• Provision of a signed and dated informed consent form.
• Subject who receives one of the following medications, that decrease bronchial hyperresponsiveness, is required for a washout period, before conducting the MCT: inhaled bronchodilators, oral albuterol , inhaled and oral glucocorticoids, leukotriene modifying agents, theophylline, cromolyn, and anti-histamines due to their anticholinergic effect.

Exclusion Criteria:

• Subjects who have known contradictions to MCT, including:

  • Tolerate inhalation of the challenge agents
  • Low baseline FEV1: Airflow limitations in FEV1 less than 60% predicted or 1.5L (baseline FEV1 of < 1.5 L or < 60% predicted).
  • Spirometry quality: inability to consistently reproduce quality spirometry
  • Cardiovascular problems: recent myocardial infarction within past three months, uncontrolled hypertension, known aortic aneurysm
  • Recent ophthalmologic surgery or patients at risk for intracranial pressure elevation.
  • Pregnancy and nursing mothers: Methacholine is a pregnancy category C drug and it is not known whether it is excreted in breast milk or is associated with fetal abnormalities. Women subjects will be asked to sign a statement, as part of the Informe Consent Form, that they are not pregnant or nursing mothers).
• Inability to provide informed consent.
• Known allergic reactions to materials used in the components of the SG, i.e., polyethylene or silicon, or gold, nickel, copper or alloys containing any of the above.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational SenseGuard Device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: NanoVation

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Actual): March 25, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PD-CLN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 6 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No