Clinical Validation of the Hyfe Cough Monitoring System

Hyfe

Status: Active, not recruiting

Conditions: Cough

Treatments: Device: Clinical Validation of the Hyfe Cough Monitoring System

Study type: Observational

Funder types: Other

Identifiers

NCT05723159

Clinical Validation of the CM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

21 participants in 3 patient groups

Clínica Universidad Navarra site

Description:

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.

Treatment:

Device: Clinical Validation of the Hyfe Cough Monitoring System

OHSU site

Description:

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.

Treatment:

Device: Clinical Validation of the Hyfe Cough Monitoring System

Decentralized - US-based

Description:

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.

Treatment:

Device: Clinical Validation of the Hyfe Cough Monitoring System