Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-27 @ 1:04 AM
Study NCT ID:
NCT05723159
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2023-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Validation of the Hyfe Cough Monitoring System
Sponsor:
Hyfe Inc
Organization:
Study Overview
Official Title:
Clinical Validation of the Hyfe Cough Monitoring System
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: