Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-24 @ 7:04 PM
NCT ID:
NCT06555757
Eligibility Criteria:
Inclusion Criteria:
* Male or Female, aged 18 years or above.
* Diagnosed with chronic stable heart failure NYHA Class 3 or 4 (either during most recent cardiology/heart failure clinic visit, or ADHF during recent/current hospitalization).
* Participant is willing and able to give informed consent for participation in the study.
* Participant has a smartphone device and can download a purposely designed mobile application on their phone (with guidance from the study investigators) or is willing to have sound recordings via a smartphone device loaned for the purpose of the study.
Exclusion Criteria:
* Unable to provide consent
* Patients requiring continuous oxygen therapy at flow rates that cannot be provided through nasal cannula
* Patients with currently known pneumonia
* Patients with known significant pulmonary disease including asthma, COPD, pulmonary fibrosis/interstitial lung disease, pulmonary hemorrhage.
* Patients with current Pulmonary embolus
* Patients with other intercurrent acute symptomatic illness (e.g., viral/bacterial infection) at time of recording
* Patients requiring continuous oxygen therapy at flow rates that cannot be provided through nasal cannula
* Patients with tracheostomy or who have undergone a surgical procedure to the head/neck/larynx which would affect the normal functioning of the vocal cords.
* Aphasic
* Patients excluded at PI discretion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06555757
Study Brief:
Protocol Section:
NCT06555757