Clinical trial NCT00595075: Ramelteon for a Nap Prior to a Night Shift
Official title: Effects of Ramelteon on Sleep and Neurobehavioral Performance in a Simulated Night Shift Preceded by a Sleep Opportunity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: sleep
performance
night shift
Ramelteon
Healthy Individuals
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2008-01-16
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Sleep Efficiency
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
measure: Post-nap Assessment - Visual Analog Scale
timeFrame: 71 minutes
measure: Post Nap Assessment - Karolinska Sleepiness Scale
timeFrame: 71 minutes
measure: Post Nap Assessment - Digit Symbol Substitution Test (Correct Answers)
timeFrame: 71 minutes
measure: Post Nap Assessment - Karolinska Drowsiness Test
timeFrame: 71 minutes
measure: Psychomotor Vigilance Task - Median Reaction Time
timeFrame: 8 hours
measure: Psychomotor Vigilance Task - Number of Lapses
timeFrame: 8 hours
Locations:
Study officials:
affiliation: Brigham and Women's Hosptial
name: Shantha Rajaratnam, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Elizabeth B Klerman, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.