NCT01669317

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

August 14, 2012

Last Update Submit

December 17, 2015

Conditions

InsomniaSleep Problem

Keywords

Cherry Juice Pilot

Outcome Measures

Primary Outcomes (1)

  • Compare the polysomnography of participants with insomnia

    Compare the polysomnography of participants with insomnia on a night at the end of 2 weeks taking: Eight ounces of standardized cherry juice vs. the night taking the placebo juice.

    Baseline and Week 4

Secondary Outcomes (3)

  • Compare the Insomnia Severity Index and validated questionnaires

    Baseline and Week 4

  • Comparison of insomnia sleep scales

    Baseline and Week 4

  • Differences in the enzyme blood test

    Baseline, Week 2 & Week 4

Study Arms (2)

Cherry Juice Standardized

EXPERIMENTAL

You will be given an 8-ounce glass of cherry juice to drink when you arrive at the Sleep Laboratory.

Other: 8-ounce glass of cherry juiceOther: Artificial Cherry Juice

Artificial Cherry Juice

PLACEBO COMPARATOR

You will be given an 8-ounce glass of artificial cherry juice to drink when you arrive at the Sleep Laboratory.

Other: 8-ounce glass of cherry juiceOther: Artificial Cherry Juice

Interventions

8-ounce glass of cherry juiceOTHER

You will be given an 8-ounce glass of cherry juice or artificial cherry juice to drink when you arrive at the Sleep Laboratory.

Artificial Cherry JuiceCherry Juice Standardized
Artificial Cherry JuiceOTHER

You will be given an 8-ounce glass of artificial cherry juice

Artificial Cherry JuiceCherry Juice Standardized

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy male or female with a usual bedtime between 9 pm and midnight.
  • 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.
  • +2 more criteria

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersParasomnias

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Frank Greenway, MD

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2012

First Posted

August 21, 2012

Study Start

June 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

US(1)