InsomniaPhase 4NCT02156271
Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance
A Phase 4 study testing ramelteon in people with Insomnia, run by Duke University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- ramelteon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jun 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 15Show fewer
- 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
Who cannot join
- 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.
About this study
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.
- Conditions
- Insomnia
- Being tested
- ramelteon, placebo
- Keywords
- Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ramelteonDrug
Also called Rozerem
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| ramelteon | Active comparator | 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. Receives: Drug: ramelteon |
| placebo | Placebo comparator | 15 subjects will be randomized to receive the placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)
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.
Measured: Day 89-90
Mean Latency to Persistent Sleep (LPS) Via Polysomnography
Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.
Measured: Day 89-90
Change in Metabolic Syndrome (MetSyn)
Measured: Baseline, Day 30, Day 60, Day 89-90
Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)
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).
Measured: baseline
Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)
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).
Measured: day 89 - 90
Mean Latency to Persistent Sleep (LPS) Via Polysomnography
Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.
Measured: Baseline
Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)
The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects.
Measured: Baseline
Secondary outcomes (7)
Change in Total Sleep Time
Change in sleep time will be determined by PSG.
Measured: Day -1-0, Day 89-90
Inflammatory Biomarkers C-reactive Protein (CRP)
Measured: Day 89-90
Interleukin 6 (IL-6)
Measured: Day 89-90
Insulin Resistance (IR)
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).
Measured: Day 89-90
Inflammatory Biomarkers C-reactive Protein (CRP)
Measured: Baseline
Insulin Resistance (IR)
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).
Measured: Baseline
Interleukin 6 (IL-6)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startJul 2007
- Primary completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Krystal, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156271
- Sponsor's protocol ID
- Pro00013501
- Status last verified
- May 2014
- First submitted
- 30 May 2014
- Last updated
- 28 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance
- ClinicalTrials.gov ID
- NCT02156271
- Acronym / sponsor ID
- Pro00013501
- Conditions
- Insomnia
- Keywords
- Insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2008 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Posted 9 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ramelteon | Active comparator | Drug: ramelteonSubjects 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. |
| placebo | Placebo comparator | Drug: placebo15 subjects will be randomized to receive the placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ramelteonAlso: Rozerem | Drug | ramelteon |
| placebo | Drug | placebo |
Primary outcome
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.
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.
Change in Metabolic Syndrome (MetSyn)
Time frame: 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).
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).
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.
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.
7 secondary outcomes
Change in Total Sleep Time
Time frame: Day -1-0, Day 89-90
Inflammatory Biomarkers C-reactive Protein (CRP)
Time frame: Day 89-90
Interleukin 6 (IL-6)
Time frame: Day 89-90
Insulin Resistance (IR)
Time frame: Day 89-90
Inflammatory Biomarkers C-reactive Protein (CRP)
Time frame: Baseline
Insulin Resistance (IR)
Time frame: Baseline
Interleukin 6 (IL-6)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Krystal, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ramelteon in people with Insomnia, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary) (time frame: Day 89-90). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.