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:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2025-12-25 @ 3:14 AM
NCT ID:
NCT03307005
Eligibility Criteria:
Inclusion Criteria:
* Age 21-79 years old
* HFrEF, EF ≤ 45% (by echocardiography)
* NYHA functional class I to III
* Able to give written consent
* On goal-directed medical therapy for HF, with stable dosing of HF medications for 2 weeks prior to enrollment
* No hospitalizations for HF within the past month
* Positive response to experiencing any of the following sleep-related symptoms at least once a week:
* Difficulty falling asleep
* Waking up during the night and having difficulty getting back to sleep
* Waking up too early in the morning and being unable to get back to sleep.
Exclusion Criteria:
* Use of sedative-hypnotics, anxiolytic, or benzodiazepines within the previous 2 weeks
* Current treatment with other sedating medications such as opioids
* On therapy for pharmacological therapy for depression
* History of alcohol/drug dependence
* History of liver disease, HIV, or severe COPD
* On Thorazine
* Current use of ketoconazole
* Current use of tricyclic antidepressants
* Current use of macrolide antibiotics
* Current use of anticonvulsant medications
* Pregnancy. A urine pregnancy test will be performed to exclude pregnancy in potential subjects.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
79 Years
Study:
NCT03307005
Study Brief:
Protocol Section:
NCT03307005