Status:
COMPLETED
Improving Sleep Quality in Heart Failure
Lead Sponsor:
Johns Hopkins University
Conditions:
Sleep Disturbance
Heart Failure
Eligibility:
All Genders
21-79 years
Phase:
PHASE4
Brief Summary
Poor sleep quality is common in patients with heart failure. The limited available evidence intimates that improving sleep quality in patients with heart failure may improve morbidity and quality of l...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03307005
Start Date
November 1 2017
End Date
January 25 2019
Last Update
February 11 2020
Active Locations (1)
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1
Johns Hopkins Bayview Campus, Asthma and Allergy Center
Baltimore, Maryland, United States, 21224