Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
US Department of Veterans Affairs
With
Stanford University
Takeda
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia
