Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance

NCT02156271 | Completed Phase 4 Results

• 1 other identifier: Pro00013501
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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). 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

Keywords

Insomnia

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  Day 89-90

• Change in Metabolic Syndrome (MetSyn)

  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).

  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).

  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.

  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.

  Baseline

Secondary Outcomes (7)

• Change in Total Sleep Time

  Day -1-0, Day 89-90

• Inflammatory Biomarkers C-reactive Protein (CRP)

  Day 89-90

• Interleukin 6 (IL-6)

  Day 89-90

• Insulin Resistance (IR)

  Day 89-90

• Inflammatory Biomarkers C-reactive Protein (CRP)

  Baseline

Study Arms (2)

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.

Drug: ramelteon

placebo

PLACEBO COMPARATOR

15 subjects will be randomized to receive the placebo

Drug: placebo

Interventions

ramelteon DRUG

Also known as: Rozerem

ramelteon

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At screening visit:
• aged 18-65
• nonsmokers
• for women: oral contraceptive (OC) or hormone replacement therapy (HRT) nonusers
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Dr. Andrew Krystal
• Organization: Duke University Medical Center

andrew.krystal@duke.edu

919-681-8742

Study Officials

• Andrew Krystal, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 5, 2014
• Study Start: July 1, 2007
• Primary Completion: June 1, 2008
• Last Updated: July 28, 2015
• Results First Posted: December 9, 2014

Record last verified: 2014-05