Ramelteon for a Nap Prior to a Night Shift

NCT00595075 | Completed Results

• 1 other identifier: Takeda - 103113
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

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. 1.ramelteon, compared with placebo, will significantly increase sleep efficiency during a 2-hour nap;
2. 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. 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

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency

  total sleep time/time in bed \* 100% (higher values indicate better outcome)

  2 hours

Other Outcomes (6)

• Post-nap Assessment - Visual Analog Scale

  71 minutes

• Post Nap Assessment - Karolinska Sleepiness Scale

  71 minutes

• Post Nap Assessment - Digit Symbol Substitution Test (Correct Answers)

  71 minutes

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Ramelteon

2

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Ramelteon DRUG

Ramelteon 8 mg tablet by mouth x 1 dose

Also known as: Rozerem

1

placebo DRUG

placebo identical in appearance to active experimental drug x 1 dose

2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Takeda: collaborator

Related Publications (1)

• 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.

  PMID: 21206545 RESULT

MeSH Terms

Interventions

ramelteon

Limitations and Caveats

Circadian phase was not measured.

Results Point of Contact

• Title: Daniel Cohen
• Organization: Sentara Neurology Specialists

dacohen@sentara.com

757-388-6323

Study Officials

• Shantha Rajaratnam, PhD

  Brigham and Women's Hosptial

  PRINCIPAL INVESTIGATOR

• Elizabeth B Klerman, MD,PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Associate Physician

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: December 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: October 30, 2012
• Results First Posted: October 12, 2012

Record last verified: 2012-10