Ramelteon for a Nap Prior to a Night Shift

NCT ID: NCT00595075

Last Updated: 2012-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-11-30

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.

Conditions

Healthy

Keywords

sleep; performance; night shift; Ramelteon; Healthy Individuals

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

1

Ramelteon 8 mg will be given once prior to a 2-hour nap

Group Type: EXPERIMENTAL

Ramelteon

Intervention Type: DRUG

Ramelteon 8 mg tablet by mouth x 1 dose

2

Placebo will be given once prior to a 2-hour nap

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo identical in appearance to active experimental drug x 1 dose

Interventions

Ramelteon

Ramelteon 8 mg tablet by mouth x 1 dose

Intervention Type: DRUG

placebo

placebo identical in appearance to active experimental drug x 1 dose

Intervention Type: DRUG

Other Intervention Names

Rozerem

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth B. Klerman

Associate Professor, Associate Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shantha Rajaratnam, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hosptial

Elizabeth B Klerman, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21206545 (View on PubMed)

Other Identifiers

Takeda - 103113

Identifier Type: -

Identifier Source: org_study_id