Conditions: Healthy
Keywords: sleep performance night shift Ramelteon Healthy Individuals
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 11
Healthy volunteers: yes

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.

Detailed description:

Arms:
arm 1: Ramelteon 8 mg will be given once prior to a 2-hour nap arm 2: Placebo will be given once prior to a 2-hour nap

Interventions: intervention 1: Ramelteon intervention 2: placebo
Intervention descriptions: intervention 1: Ramelteon 8 mg tablet by mouth x 1 dose intervention 2: placebo identical in appearance to active experimental drug x 1 dose

Protocol document: