- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02156271
Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance
July 9, 2015 updated by: Duke University
The purpose of this study is to help scientist better understand the effect of a 12-week single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U. S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep or staying asleep).
The study will measure levels of inflammation, fasting insulin and fasting glucose (sugar) in subjects who are taking either ramelteon (8 mg) or placebo.
Study Overview
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
At screening visit:
- aged 18-65
- nonsmokers
- for women: oral contraceptive (OC) or hormone replacement therapy (HRT) nonusers
To schedule the baseline PSG (Visit 2), subjects must meet the following inclusion criteria:
- ages 18-65 inclusive;
- PSQI-Component 2 (sleep latency) score of greater than 1;
- non-smoker (e.g., less than 20 cigarettes in the past 5 years);
- habitual bedtime between 8:30 pm and midnight
For premenopausal women:
- regular menstrual cycles determined by Framingham Study criteria;
- not pregnant and no history of oral contraceptive (OC) usage in last 6-months.
For postmenopausal women:
- no recent (< 6 months) use of Hormone Replacement Therapy (HRT)
- no surgical menopause
Exclusion Criteria:
- positive urine drug screen
- Potential subjects with hypersensitivity to ramelteon or any components of the formulation will be excluded from participation.
- Given that ramelteon should not be used by individuals with severe hepatic impairment, or in patients in combination with fluvoxamine, individuals who report liver problem or use of fluvox will be excluded.
- use of rifampin (Rifadin ©); ketoconazole (Nizora ©l); or fluconazole (Diflucan ©).
- Ramelteon has not been studied in children or adolescents, and the effects in these populations are unknown, thus only individuals above 18 years will participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ramelteon
Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water.
Subjects have a 2 out of 3 chance of receiving ramelteon.
|
Other Names:
|
Placebo Comparator: placebo
15 subjects will be randomized to receive the placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)
Time Frame: Day 89-90
|
The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects.
Sleep latency is defined as the length of time it takes from lying down for the night until sleep onset.
|
Day 89-90
|
Mean Latency to Persistent Sleep (LPS) Via Polysomnography
Time Frame: Day 89-90
|
Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.
|
Day 89-90
|
Change in Metabolic Syndrome (MetSyn)
Time Frame: Baseline, Day 30, Day 60, Day 89-90
|
Baseline, Day 30, Day 60, Day 89-90
|
|
Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)
Time Frame: baseline
|
Subjects completed component 2 of the PSQI questionnaire.
Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse).
|
baseline
|
Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)
Time Frame: day 89 - 90
|
Subjects completed component 2 of the PSQI questionnaire.
Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse).
|
day 89 - 90
|
Mean Latency to Persistent Sleep (LPS) Via Polysomnography
Time Frame: Baseline
|
Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.
|
Baseline
|
Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)
Time Frame: Baseline
|
The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Sleep Time
Time Frame: Day -1-0, Day 89-90
|
Change in sleep time will be determined by PSG.
|
Day -1-0, Day 89-90
|
Inflammatory Biomarkers C-reactive Protein (CRP)
Time Frame: Day 89-90
|
Day 89-90
|
|
Interleukin 6 (IL-6)
Time Frame: Day 89-90
|
Day 89-90
|
|
Insulin Resistance (IR)
Time Frame: Day 89-90
|
In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at day 89-90.
Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5.
Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).
|
Day 89-90
|
Inflammatory Biomarkers C-reactive Protein (CRP)
Time Frame: Baseline
|
Baseline
|
|
Insulin Resistance (IR)
Time Frame: Baseline
|
In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at baseline.
Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5.
Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).
|
Baseline
|
Interleukin 6 (IL-6)
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Krystal, MD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
June 1, 2008
Study Completion
December 6, 2022
Study Registration Dates
First Submitted
May 30, 2014
First Submitted That Met QC Criteria
June 3, 2014
First Posted (Estimate)
June 5, 2014
Study Record Updates
Last Update Posted (Estimate)
July 28, 2015
Last Update Submitted That Met QC Criteria
July 9, 2015
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00013501
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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