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Ramelteon for a Nap Prior to a Night Shift

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Elizabeth B. Klerman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00595075
First received: January 7, 2008
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

Night shift-workers are often advised to take a prophylactic nap prior to starting the shift in order to improve alertness and performance. However, individuals often report difficulty initiating and maintaining sleep at that time of the day secondary to the alerting influence of the near-24 hour circadian rhythm (biological clock). A sleep-promoting medication may improve the quality of an evening nap and subsequent alertness and performance during a night shift. We will use Ramelteon, a melatonin agonist that is FDA approved for insomnia, in order to test the following hypotheses:

  1. ramelteon, compared with placebo, will significantly increase sleep efficiency during a 2-hour nap;
  2. sleep inertia, as assessed by neurobehavioral tests and subjective and objective sleepiness assessments will not be significantly increased after ramelteon treatment compared with placebo treatment; and
  3. neurobehavioral performance, subjective and objective sleepiness, and subjective mood during a simulated 8-hour night shift will be significantly improved when ramelteon is given prior to a prophylactic nap compared to a prophylactic nap with placebo.

Condition Intervention
Healthy
Drug: Ramelteon
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Ramelteon on Sleep and Neurobehavioral Performance in a Simulated Night Shift Preceded by a Sleep Opportunity

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Sleep Efficiency [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    total sleep time/time in bed * 100% (higher values indicate better outcome)


Other Outcome Measures:
  • Post-nap Assessment - Visual Analog Scale [ Time Frame: 71 minutes ] [ Designated as safety issue: No ]
    numerical scale of increasing alertness from 0-100 (higher values are better outcome)

  • Post Nap Assessment - Karolinska Sleepiness Scale [ Time Frame: 71 minutes ] [ Designated as safety issue: No ]
    numerical scale of increasing sleepiness from 1-9 (higher values indicate worse outcome)

  • Post Nap Assessment - Digit Symbol Substitution Test (Correct Answers) [ Time Frame: 71 minutes ] [ Designated as safety issue: No ]
    A cognitive throughput task consisting of matching symbols to numerical keys; higher numbers indicate a better score

  • Post Nap Assessment - Karolinska Drowsiness Test [ Time Frame: 71 minutes ] [ Designated as safety issue: No ]
    EEG spectral analysis of 5.5-9.0 Hz frequency activity (theta low-frequency alpha), with higher activity indicating increased drowsiness and worse outcome

  • Psychomotor Vigilance Task - Median Reaction Time [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Visual-motor reaction time in which participants hit a button on a response box as fast as possible in response to a visual target (lower values indicate better outcome)

  • Psychomotor Vigilance Task - Number of Lapses [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Number of trials per test battery with a reaction time >0.5 seconds (higher values indicate worse outcome)


Enrollment: 11
Study Start Date: December 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ramelteon 8 mg will be given once prior to a 2-hour nap
Drug: Ramelteon
Ramelteon 8 mg tablet by mouth x 1 dose
Other Name: Rozerem
Placebo Comparator: 2
Placebo will be given once prior to a 2-hour nap
Drug: placebo
placebo identical in appearance to active experimental drug x 1 dose

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged between 18-35 years;
  • Non-smoking for at least 6 months;
  • Healthy (no medical, psychiatric or sleep disorders);
  • No clinically significant deviations from normal in medical history, vital signs, physical examination, blood chemistry and hematology, and ECG;
  • Women of childbearing potential must agree to use an acceptable method of birth control, and must have a negative serum pregnancy test;
  • Body mass index of > 18 or < 30 kg/m∧2;
  • No drugs or medication likely to affect sleep or alertness, as determined by the investigators;
  • Habitual caffeine consumption < 300 mg per day on average;
  • Habitual alcohol consumption < 10 alcoholic units per week on average.

Exclusion Criteria:

  • History of alcohol or substance abuse;
  • Positive result on drugs of abuse screening;
  • Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, or any significant sleep complaint;
  • Psychiatric disorder, including a history of depression or dysthymia (characterized by depressed mood on the majority of days for at least two years);
  • Recent acute or chronic medical disorder, including but not limited to hepatic impairment and severe chronic obstructive pulmonary disease;
  • History of intolerance or hypersensitivity to melatonin or melatonin agonists;
  • Pregnancy or lactation;
  • Shift work;
  • Transmeridian travel (2 or more time zones) in past 2 months;
  • Any other scientific or medical reason, as determined by the PI, such as non-compliance with protocol or intolerance to inpatient study conditions.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595075

Sponsors and Collaborators
Brigham and Women's Hospital
Takeda
Investigators
Principal Investigator: Shantha Rajaratnam, PhD Brigham and Women's Hosptial
Principal Investigator: Elizabeth B Klerman, MD,PhD Brigham and Women's Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Elizabeth B. Klerman, Associate Professor, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00595075     History of Changes
Other Study ID Numbers: Takeda - 103113
Study First Received: January 7, 2008
Results First Received: July 22, 2010
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
sleep
performance
night shift
Ramelteon
Healthy Individuals

ClinicalTrials.gov processed this record on November 27, 2014