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NCT05723159
Clinical Validation of the Hyfe Cough Monitoring System
Conditions: Cough
Sex: All
Ages: 21 Years – N/A
Enrollment: 15
Sponsor: Hyfe Inc
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Age 21 years old or aboveIndividuals seeking health care, who express concern about their active coughAnticipate 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 and MP3 recorder and keep it at bedside (within 3 ft) from the mouth during the night.Exclusion Criteria:Inability to accept the privacy policy and terms of use of Hyfe Cough Monitoring System 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 periodIndividuals who have had significant change in antitussive therapy in the week preceding study.
Source: ClinicalTrials.gov (NCT05723159). StuddyBuddy aggregates publicly available trial information.