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Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Primary Purpose

Insomnia, Spinal Cord Injury, Tetraplegia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ramelteon
Placebo
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring sleep, melatonin, spinal cord injury, insomnia, tetraplegia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ramelteon then placebo

Placebo then ramelteon

Arm Description

8 mg nightly ramelteon for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of nightly placebo (cross-over)

placebo nightly for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of 8 mg nightly ramelteon (cross-over)

Outcomes

Primary Outcome Measures

Amount of Wakefulness After Sleep Onset (WASO)
Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment

Secondary Outcome Measures

Change in Subjective Morning Alertness
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

Full Information

First Posted
July 25, 2007
Last Updated
April 25, 2014
Sponsor
US Department of Veterans Affairs
Collaborators
Stanford University, Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00507546
Brief Title
Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia
Official Title
Melatonin Replacement for Treatment of Sleep Disruption
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Stanford University, Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Spinal Cord Injury, Tetraplegia, Sleep Disorders
Keywords
sleep, melatonin, spinal cord injury, insomnia, tetraplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ramelteon then placebo
Arm Type
Experimental
Arm Description
8 mg nightly ramelteon for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of nightly placebo (cross-over)
Arm Title
Placebo then ramelteon
Arm Type
Experimental
Arm Description
placebo nightly for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of 8 mg nightly ramelteon (cross-over)
Intervention Type
Drug
Intervention Name(s)
Ramelteon
Other Intervention Name(s)
Rozerem
Intervention Description
8 mg nightly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Nightly 8mg of placebo (same appearance as ramelteon)
Primary Outcome Measure Information:
Title
Amount of Wakefulness After Sleep Onset (WASO)
Description
Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Change in Subjective Morning Alertness
Description
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
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie M. Zeitzer, PhD
Organizational Affiliation
VA Palo Alto Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24090266
Citation
Zeitzer JM, Ku B, Ota D, Kiratli BJ. Randomized controlled trial of pharmacological replacement of melatonin for sleep disruption in individuals with tetraplegia. J Spinal Cord Med. 2014 Jan;37(1):46-53. doi: 10.1179/2045772313Y.0000000099. Epub 2013 Oct 24.
Results Reference
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Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

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