Mechanisms Underlying the Sleep Promoting Effect of Cherry Juice Standardized to Its Proanthocyanidin Content
Completed · Not applicable
Conditions studied: Insomnia, Sleep Problem
In brief
This study is designed to demonstrate that cherry juice is effective in treating insomnia, and to show that it works by inhibiting an enzyme that will be measured in the blood.
Key facts
- Study ID
- NCT01669317
- Run by
- Pennington Biomedical Research Center
- People needed
- 10
- Starts
- 2014-06-01
- Expected to finish
- 2015-10-01
- Last updated by the study team
- 2015-12-18
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male or female with a usual bedtime between 9 pm and midnight.
- 65 years of age or older.
- Sleep problem >3 nights per week, meeting the International Classification of Sleep Disorders (ICSD-2*) diagnostic criteria of insomnia for at least 6 months.
- An insomnia severity index ≥ 10 and a minimum of 30 minutes of either sleep-onset latency (SL) or wake after sleep onset (WASO).
- ICSD-2 general criteria for insomnia:
- A complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early, or sleep that is chronically non-restorative or poor in quality.
- The above sleep difficulty occurs despite adequate opportunity and circumstances for sleep.
- At least one of the following forms of daytime impairment related to the nighttime sleep difficulty is reported by the patient:
- Fatigue or malaise.
- Attention, concentration, or memory impairment.
- Social or vocational dysfunction or poor school performance.
- Mood disturbance or irritability.
- Daytime sleepiness.
- Motivation, energy, or initiative reduction.
- Proneness for errors or accidents at work or while driving.
- Tension, headaches, or gastrointestinal symptoms in response to sleep loss.
- Concerns or worries about sleep.
You may not qualify if…
- Diabetes.
- Sedating or hypnotic medications.
- Any chronic medication that has not had a stable dose for 1 month or longer.
Where it is running
- Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
Full record on ClinicalTrials.gov
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