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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

January 7, 2008
October 24, 2012
December 2007
November 2008   (final data collection date for primary outcome measure)
Sleep Efficiency [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
total sleep time/time in bed * 100% (higher values indicate better outcome)
  • Sleep efficiency [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Neurobehavioral performance battery [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00595075 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • 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)
Not Provided
 
Ramelteon for a Nap Prior to a Night Shift
Effects of Ramelteon on Sleep and Neurobehavioral Performance in a Simulated Night Shift Preceded by a Sleep Opportunity

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
  • Drug: Ramelteon
    Ramelteon 8 mg tablet by mouth x 1 dose
    Other Name: Rozerem
  • Drug: placebo
    placebo identical in appearance to active experimental drug x 1 dose
  • Experimental: 1
    Ramelteon 8 mg will be given once prior to a 2-hour nap
    Intervention: Drug: Ramelteon
  • Placebo Comparator: 2
    Placebo will be given once prior to a 2-hour nap
    Intervention: Drug: placebo
Cohen DA, Wang W, Klerman EB, Rajaratnam SM. Ramelteon prior to a short evening nap impairs neurobehavioral performance for up to 12 hours after awakening. J Clin Sleep Med. 2010 Dec 15;6(6):565-71.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00595075
Takeda - 103113
No
Elizabeth B. Klerman, Brigham and Women's Hospital
Brigham and Women's Hospital
Takeda
Principal Investigator: Shantha Rajaratnam, PhD Brigham and Women's Hosptial
Principal Investigator: Elizabeth B Klerman, MD,PhD Brigham and Women's Hospital
Brigham and Women's Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP