Clinical Validation of the Hyfe Cough Monitoring System
Status unconfirmed
Conditions studied: Cough
In brief
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.
Key facts
- Study ID
- NCT05723159
- Run by
- Hyfe Inc
- People needed
- 21
- Starts
- 2023-03-10
- Expected to finish
- 2023-12-15
- Last updated by the study team
- 2023-09-28
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Oregon Health Science University — Oregon City, Oregon, United States
- Hyfe North American Clinical Office — Seattle, Washington, United States
- Clínica Universidad de Navarra — Navarro, Spain
Full record on ClinicalTrials.gov
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