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OpenTrials
Completed

NCT Number: NCT00507546

Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

The purpose of this study is to determine if replacing melatonin function with a melatonin agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia) helps to alleviate self-reported sleep disruption.

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Key information

Conditions

Insomnia Central Nervous System Diseases Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Sleep Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Tetraplegia Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older, male or female veterans of any racial or ethnic group
  • Neurologically complete (Frankel A or B) damage to the lower (C4-C8) cervical spinal cord
  • Absence of melatonin production
  • Time since SCI is greater than 6 months [no cases of acute spinal cord injury]
  • Subjective complaint of sleep disruption

Exclusion criteria

  • Current use of fluvoxamine (Luvox , antidepressant), rifampin (antimycobacterial), ketoconazole (Nizoral , antifungal), or fluconazole (Diflucan , antifungal) [these interact with the same liver enzyme that is the primary metabolizer of ramelteon]; use of sleep medications is okay
  • Hepatic dysfunction
  • Concomitant use of over-the-counter melatonin
  • Pregnancy or breast feeding
  • Currently or have within the past six months met DSM-IV (Diagnosis and Statistical Manual IV) criteria for drug or alcohol abuse or dependence or AUDIT score >19
  • Acute illness or unstable chronic illness. Use of continuous positive airway pressure (CPAP) for treatment of sleep apnea is acceptable.
  • No travel across three or more time zones within three weeks or during the protocol
  • Illiterate or unable to read or write English or are judged by the investigator to be unable or unlikely to follow the study protocol

Treatment and study plan

Ramelteon

Drug

8 mg nightly

Other names: Rozerem

Placebo

Drug

Nightly 8mg of placebo (same appearance as ramelteon)

Primary outcomes

  1. Amount of Wakefulness After Sleep Onset (WASO)

    Time frame: 10 weeks

    Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment

Secondary outcomes

  1. Change in Subjective Morning Alertness

    Time frame: 10 weeks

    Measured as the median of the average morning alertness (measured from 1-7 on the Stanford Sleepiness Scale, a Likert-like scale in which higher values are lower alertness) of the three weeks of either placebo or ramelteon treatment

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Collaborators

  • Stanford University
  • Takeda

Registry information

Official study title

Melatonin Replacement for Treatment of Sleep Disruption

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Jul 26, 2007
Registry last updated
May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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