Dispersed Clinical Validation of the Hyfe Cough Monitoring System

NCT06775301 | Completed FDA Device

• 1 other identifier: ID206-2
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the accuracy of the Hyfe Cough Monitoring System. This system uses a smartwatch to record the number and pattern of coughs (like a "Fitbit for cough"). The investigators will compare the coughs counted by the Hyfe device with manual cough counts from environmental sounds recordings in the same period. This is a dispersed observational study and will include individuals with a variety of cough related conditions including but not limited to refractory or unexplained cough, Bronchiectasis, COPD, COVID-19, non-tuberculous mycobacterial infection, tuberculosis, or upper respiratory tract infection.

Conditions

Cough Frequency

Keywords

Cough monitoring

Outcome Measures

Primary Outcomes (1)

• Hour by hour cough count agreement using Bland Altman

  Concordance with human annotators using Bland Altman analysis with 95%CI

  24 hours

Secondary Outcomes (2)

• Hour by hour cough count agreement using linear analysis

  24 hours

• Event by event cough count analysis

  24 hours

Other Outcomes (3)

• Differential performance of Hyfe day/night

  24 hours

• Differential performance of Hyfe between individuals

  24 hours

• Differential performance of Hyfe between high, middle and low cough rates

  24 hours

Interventions

Hyfe Cough Monitoring System DIAGNOSTIC_TEST

Smartwatch-based cough monitoring

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects residing in the United States who have problematic coughs due to a variety of etiologies who are willing and able to participate in a decentralized study

You may qualify if:

• Age 21 or older
• Have problematic cough defined as an expressed concern about their cough
• Able to collect 24 hour auditory recording
• Reside in location without unusually high noise
• Willing to wear watches for 24 hours
• Fluent in English
• Access to a device for video calls
• Have an iPhone for download of the Hyfe Companion App
• Accept the Hyfe Companion App Terms of Use and Privacy Policy

You may not qualify if:

• Ongoing relationship with any company making a cough monitor
• Participation in a cough monitor device study in the past 6 months
• Have privacy concerns
• Inability to avoid unusually loud environments
• Significant antitussive therapy changes in preceding week

Sponsors & Collaborators

• Hyfe Inc: lead
• University of Washington: collaborator

Study Sites (1)

Hyfe. Inc

Ottawa, Montana, K2B 6R1, Canada

Location

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter M Small, MD

  Hyfe Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 15, 2025
• Study Start: January 2, 2025
• Primary Completion: July 8, 2025
• Study Completion: August 29, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within one year of study end
• Access Criteria: Upon contacting the PI with reasonable request

Locations

CA (1)