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Clinical Validation of the Hyfe Cough Monitoring System

NCT05723159 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2023-09-28

No results posted yet for this study

Summary

This is a multicenter observational study and will include individuals with a variety of cough related conditions including but not limited to refractory chronic cough, Chronic Obstructive Pulmonary Disease (COPD) and non-tuberculous mycobacteria.

The primary objective of this study is to assess the overall performance of the Hyfe Cough Monitoring System (HCMS, Hyfe Inc., 2022) when used by individuals with problematic cough, under common living conditions.The monitoring period for outpatients will be 24 hours.

Conditions

Interventions

DEVICE

Clinical Validation of the Hyfe Cough Monitoring System

The subjects will be instructed to not turn off either watch for the duration of the 24 hours. In addition, participants will be instructed to avoid environments with active coughers and to inform others in their environment that sound is being recorded. Additionally, participants will be told to avoid getting the watches wet. Participants will be instructed to charge the watches on a nightstand next to the bed while they sleep using the provided watch chargers. At the end of the 24-hour period, participants will be instructed to turn off and remove the watches. Additionally, participants will be given a printed Hyfe diary to write down the exact time when the device was turned on/off and any times the watch was not being worn. The devices will be returned to the researchers once the recording period is complete.

Sponsors & Collaborators

  • Hyfe Inc

    lead OTHER

Principal Investigators

  • Carlos Chaccour · Clínica Universidad de Navarra

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-10
Primary Completion
2023-11-15
Completion
2023-12-15
FDA Device
Yes

Countries

  • United States
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT05723159 on ClinicalTrials.gov