Clinical trial NCT05723159: Clinical Validation of the Hyfe Cough Monitoring System
Official title: Clinical Validation of the Hyfe Cough Monitoring System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cough
Lead sponsor: Hyfe Inc
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Researcher will evaluate the accuracy of the mobile HCMS as a tool to monitor cough. HCMS is a dedicated Android smart watch running specialized software that runs continuously and calculates a patient's cough rate on an hourly basis. After providing informed consent, 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.

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, they 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.The 24 hours of continuous ambient sounds collected by the audio recording watch and will be listened to by Hyfe technicians trained in cough annotation and data security, and each coughwill be annotated on the audio file using audio-analysis software, according to standard operating procedures developed by Hyfe. These results will be compared on an hourly basis with the coughs detected by HCMS and the performance of the HCMS for identifying cough in home settings calculated in comparison to the human annotated continuous recording reported.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Hyfe Cough Monitoring System (HCMS) accuracy using Pearson correlation coefficient
timeFrame: 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.
measure: Hyfe Cough Monitoring System (HCMS) accuracy using OLS slope/intercept
timeFrame: 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
measure: Hyfe Cough Monitoring System (HCMS) sensitivity of cough detection
timeFrame: 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.
measure: Hyfe Cough Monitoring System (HCMS) false positivity rate
timeFrame: 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:
measure: Differential analysis of nighttime versus daytime HCMS performance
timeFrame: 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
measure: Differential analysis of HCMS performance for individual subjects
timeFrame: 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
measure: Dependence of HCMS performance on individual cough rates
timeFrame: 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
Other outcomes:
Locations:
city: Oregon City
country: United States
facility: Oregon Health Science University
state: Oregon
city: Seattle
country: United States
facility: Hyfe North American Clinical Office
state: Washington
city: Navarro
country: Spain
facility: Clínica Universidad de Navarra
Study officials:
affiliation: Clínica Universidad de Navarra
name: Carlos Chaccour
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.