Clinical Validation of the Hyfe Cough Monitoring System
Study Details
Study Description
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, COPD and non-tuberculous mycobacteria.
The primary objective of this study is to determine the accuracy of the Hyfe Cough Monitoring System (HCMS) (Hyfe Inc., 2022) to monitor cough frequency in patients with cough under common living conditions.The monitoring period for outpatients will be 24 hours conducted under the participants standard living conditions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
We will evaluate the accuracy of the mobile Hyfe Cough Monitoring System as a tool to monitor cough. Hyfe Cough Monitoring System 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 Hyfe Cough Monitoring and a second watch serving as an MP3 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, they 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 MP3 recording watch will belistened 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 standardoperating procedures developed by Hyfe. These results will be compared on an hourly basis with the coughs detected by Hyfe Cough Monitoring System and the performance of the Hyfe Cough Monitoring System for identifying cough in home settings calculated in comparison to the human annotated continuous recording reported.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Clínica Universidad Navarra site 8 research subjects will be enrolled at Clínica Universidad Navarra. Research subjects will be instructed to wear the Hyfe Watch and a second watch serving as an MP3 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
The subjects will be instructed to not turn off either watch for the duration of the 24 hours. In addition, they 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.
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| OHSU site 8 research subjects will be enrolled at OHSU. Research subjects will be instructed to wear the Hyfe Watch and a second watch serving as an MP3 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
The subjects will be instructed to not turn off either watch for the duration of the 24 hours. In addition, they 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.
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Outcome Measures
Primary Outcome Measures
- Estimates of the linear analysis parameters (Pearson correlation coefficient, OLS slope, OLS intercept) used to quantify the accuracy of the HCMS [Each participant will be monitored continuously with the MP3 recorder and the HCMS for 24 hours, and coughs will be tabulated hourly. Each participant will thus contribute 24 data points to the calculation of the primary outcome measures.]
The HCMS timestamps users' coughs as they occur. Coughs are tabulated hourly, yielding 1 observation per subject per hour of monitoring. To determine each subject's true hourly cough counts, human annotators trained in cough recognition listen to continuous audio recordings and timestamp each cough using proprietary labeling software. Hourly tabulations of these annotations form the gold standard reference. The HCMS hourly cough counts are compared, hour by hour for all subjects, with the gold standard counts. If human annotators and the HCMS agreed perfectly, the paired counts would lie on the ideal line y=x, with gold standard counts on the x-axis and HCMS counts on the y-axis. The agreement between paired counts and this ideal line quantifies the performance of the HCMS: the Pearson correlation coefficient between paired person-hour counts must be close to +1, and the slope and intercept of the linear model summarizing their relationship must be close to 1 and 0, respectively.
Secondary Outcome Measures
- The sensitivity and false positive rate of the HCMS's detection of coughs [Each participant will be monitored continuously with the MP3 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]
As described in the description of the primary outcome measures, trained human annotators will establish ground truth for all participants by listening to the continuous audio recordings and timestamping all coughs. The HCMS will also timestamp participants' coughs as they occur. By comparing these timestamps with the ground truth cough annotations, each cough detected by the HCMS will be classified as either a true positive or a false positive. The sensitivity of the HCMS will then be calculated according to the usual formula, Sensitivity = Number of true positives/Total number of coughs, where the total number of coughs is determined by ground truth. The false positive rate equals the total number of false positives divided by the total number of hours of monitoring. The sensitivity and false positive rate will be reported for the cohort overall and for each individual participant.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 21 years old or above
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Individuals seeking health care, who express concern about their active cough
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Anticipate that they can collect auditory recording and keep the devices with them continuously for 24 hours.
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Residing in a domestic environment without unusually high and / or persistent background sound levels .
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Willing to wear a watch and MP3 recorder and keep it at bedside (within 3 ft) from the mouth during the night.
Exclusion Criteria:
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Inability to accept the privacy policy and terms of use of Hyfe Cough Monitoring System due to confidentiality or other concerns.
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Inability to avoid unusually prolonged loud environments for the duration of the 24-hour study period.
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Need to conduct confidential conversations during the 24-hour monitoring period
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Individuals who have had significant change in antitussive therapy in the week preceding study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oregon Health Science University | Oregon City | Oregon | United States | 97239 |
| 2 | Clínica Universidad de Navarra | Navarro | Spain |
Sponsors and Collaborators
- Hyfe Inc
Investigators
- Principal Investigator: Carlos Chaccour, Clínica Universidad de Navarra
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Clinical Validation of the CM