Clinical Validation of the Hyfe Cough Monitoring System

NCT05723159 | Unknown FDA Device

• 1 other identifier: Clinical Validation of the CM
• Study Type: observational
• Target: 21
• Locations: 2 countries
• Sites: 3

Brief 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

Cough

Outcome Measures

Primary Outcomes (4)

• Hyfe Cough Monitoring System (HCMS) accuracy using Pearson correlation coefficient

  The HCMS timestamps coughs as they occur. Hourly counts of cough events will be compared with ground truth hourly counts determined by trained human annotators, who will listen to audio recordings and timestamp each cough using proprietary labeling software. If human annotators and the HCMS agreed perfectly, their paired hourly counts would lie on the line y=x (ground truth on the x-axis, HCMS on the y-axis). Agreement with this ideal line quantifies HCMS performance: the Pearson correlation coefficient must be close to 1 By comparison with ground truth annotations, each HCMS timestamp is either a true positive or a false positive; by the usual formula, HCMS Sensitivity = Number of true positives Total number of coughs where the denominator is determined by ground truth.

  Each participant will be monitored continuously with the audio recorder and the HCMS for 24 hours, and cough events will be tabulated hourly. Each participant will thus contribute 24 data points to the calculation of the primary outcome measures.

• Hyfe Cough Monitoring System (HCMS) accuracy using OLS slope/intercept

  The HCMS timestamps coughs as they occur. Hourly counts of cough events will be compared with ground truth hourly counts determined by trained human annotators, who will listen to audio recordings and timestamp each cough using proprietary labeling software. If human annotators and the HCMS agreed perfectly, their paired hourly counts would lie on the line y=x (ground truth on the x-axis, HCMS on the y-axis). Agreement with this ideal line quantifies HCMS performance: the slope and intercept of the OLS line of best fit must be close to 1 and 0, respectively. By comparison with ground truth annotations, each HCMS timestamp is either a true positive or a false positive; by the usual formula HCMS Sensitivity = Number of true positives Total number of coughs where the denominator is determined by ground truth.

  Each participant will be monitored continuously with the audio recorder and the HCMS for 24 hours, and cough events will be tabulated hourly. Each participant will thus contribute 24 data points to the calculation of the co-primary outcome measures

• Hyfe Cough Monitoring System (HCMS) sensitivity of cough detection

  The HCMS timestamps coughs as they occur. Hourly counts of cough events will be compared with ground truth hourly counts determined by trained human annotators, who will listen to audio recordings and timestamp each cough using proprietary labeling software. By comparison with ground truth annotations, each HCMS timestamp is either a true positive or a false positive; by the usual formula HCMS Sensitivity = Number of true positives Total number of coughs where the denominator is determined by ground truth.

  Each participant will be monitored continuously with the audio recorder and the HCMS for 24 hours, and cough events will be tabulated hourly. Each participant will thus contribute 24 data points to the calculation of the co-primary outcome measures.

• Hyfe Cough Monitoring System (HCMS) false positivity rate

  The HCMS timestamps coughs as they occur. Hourly counts of cough events will be compared with ground truth hourly counts determined by trained human annotators, who will listen to audio recordings and timestamp each cough using proprietary labeling software. The false positive rate is the total number of false positives divided by the total number of monitoring hours.

  Each participant will be monitored continuously with the audio recorder and the HCMS for 24 hours, and cough events will be tabulated hourly. Each participant will thus contribute 24 data points to the calculation of the co-primary outcome measures.

Secondary Outcomes (3)

• Differential analysis of nighttime versus daytime HCMS performance

  Each participant will be monitored continuously with the audio recorder and the HCMS for 24 hours. All of the coughs timestamped by trained human annotators and by the Hyfe Cough Monitoring System will be used to calculate the second

• Differential analysis of HCMS performance for individual subjects

  Each participant will be monitored continuously with the audio recorder and the Hyfe Cough Monitoring System for 24 hours. All of the coughs timestamped by trained human annotators and by the HCMS will be used to calculate the seco

• Dependence of HCMS performance on individual cough rates

  Each participant will be monitored continuously with the audio recorder and the Hyfe Cough Monitoring System for 24 hours. All of the coughs timestamped by trained human annotators and by the HCMS will be used to calculate the seco

Study Arms (3)

Clínica Universidad Navarra site

Research subjects will be enrolled at Clínica Universidad Navarra. Research subjects will be instructed to wear the HCMS and a second watch serving as an audio recorder. These devices will be kept on the wrist or within 3 feet (\~91 cm) of the mouth, a behavior abetted by keeping the charging station for both watches on the bedside table. Participants will be asked to go about their day as usual while wearing these devices.

Device: Clinical Validation of the Hyfe Cough Monitoring System

OHSU site

Research subjects will be enrolled at OHSU. Research subjects will be instructed to wear the HCMS and a second watch serving as an audio recorder. These devices will be kept on the wrist or within 3 feet (\~91 cm) of the mouth, a behavior abetted by keeping the charging station for both watches on the bedside table. Participants will be asked to go about their day as usual while wearing these devices.

Device: Clinical Validation of the Hyfe Cough Monitoring System

Decentralized - US-based

Research subjects will be enrolled in a decentralized manner ou of the Hyfe North American Clinical Office. Research subjects will be instructed to wear the HCMS and a second watch serving as an audio recorder. These devices will be kept on the wrist or within 3 feet (\~91 cm) of the mouth, a behavior abetted by keeping the charging station for both watches on the bedside table. Participants will be asked to go about their day as usual while wearing these devices.

Device: Clinical Validation of the Hyfe Cough Monitoring System

Interventions

Clinical Validation of the Hyfe Cough Monitoring System DEVICE

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.

Clínica Universidad Navarra site; Decentralized - US-based; OHSU site

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

The study population are adults (21 years old or above) seeking health care and who express concern about their cough.

You may qualify if:

• Age 21 years old or above
• Individuals seeking health care, who express concern about their active cough (problematic cough)
• Anticipate that they can collect auditory recording and keep the devices with them continuously for 24 hours.
• Residing in a domestic environment without unusually high and / or persistent background sound levels .
• Willing to wear a watch an audio recorder and keep them at bedside (within 3 ft) from the mouth during the night.

You may not qualify if:

• Inability to accept the privacy policy and terms of use of HCMS due to confidentiality or other concerns.
• Inability to avoid unusually prolonged loud environments for the duration of the 24-hour study period.
• Need to conduct confidential conversations during the 24-hour monitoring period
• Individuals who have had significant change in antitussive therapy in the week preceding study.

Sponsors & Collaborators

• Hyfe Inc: lead

Study Sites (3)

Oregon Health Science University

Oregon City, Oregon, 97239, United States

Location

Hyfe North American Clinical Office

Seattle, Washington, 98105, United States

Location

Clínica Universidad de Navarra

Navarro, Spain

Location

Related Publications (6)

• Decalmer SC, Webster D, Kelsall AA, McGuinness K, Woodcock AA, Smith JA. Chronic cough: how do cough reflex sensitivity and subjective assessments correlate with objective cough counts during ambulatory monitoring? Thorax. 2007 Apr;62(4):329-34. doi: 10.1136/thx.2006.067413. Epub 2006 Nov 13.

  PMID: 17101736 BACKGROUND

• Leconte S, Ferrant D, Dory V, Degryse J. Validated methods of cough assessment: a systematic review of the literature. Respiration. 2011;81(2):161-74. doi: 10.1159/000321231. Epub 2010 Nov 13.

  PMID: 21079381 BACKGROUND

• Barton A, Gaydecki P, Holt K, Smith JA. Data reduction for cough studies using distribution of audio frequency content. Cough. 2012 Dec 12;8(1):12. doi: 10.1186/1745-9974-8-12.

  PMID: 23231789 BACKGROUND

• Matos S, Birring SS, Pavord ID, Evans DH. An automated system for 24-h monitoring of cough frequency: the leicester cough monitor. IEEE Trans Biomed Eng. 2007 Aug;54(8):1472-9. doi: 10.1109/TBME.2007.900811.

  PMID: 17694868 BACKGROUND

• Gabaldon-Figueira JC, Brew J, Dore DH, Umashankar N, Chaccour J, Orrillo V, Tsang LY, Blavia I, Fernandez-Montero A, Bartolome J, Grandjean Lapierre S, Chaccour C. Digital acoustic surveillance for early detection of respiratory disease outbreaks in Spain: a protocol for an observational study. BMJ Open. 2021 Jul 2;11(7):e051278. doi: 10.1136/bmjopen-2021-051278.

  PMID: 34215614 BACKGROUND

• Chaccour C, Sanchez-Olivieri I, Siegel S, Megson G, Winthrop KL, Botella JB, de-Torres JP, Jover L, Brew J, Kafentzis G, Galvosas M, Rudd M, Small P. Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study. Sci Rep. 2025 Jan 6;15(1):880. doi: 10.1038/s41598-025-85341-3.

  PMID: 39762316 DERIVED

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

• Carlos Chaccour

  Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 10, 2023
• Study Start: March 10, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 15, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be made available upon publication
• Access Criteria: IPD will be available via an open repository

Locations

ES (1); US (2)