Conditions: Insomnia Spinal Cord Injury Tetraplegia Sleep Disorders
Keywords: sleep melatonin spinal cord injury insomnia tetraplegia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 12
Healthy volunteers: yes

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.

Detailed description:

Arms:
arm 1: 8 mg nightly ramelteon for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of nightly placebo (cross-over) arm 2: placebo nightly for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of 8 mg nightly ramelteon (cross-over)

Interventions: intervention 1: Ramelteon intervention 2: Placebo
Intervention descriptions: intervention 1: 8 mg nightly intervention 2: Nightly 8mg of placebo (same appearance as ramelteon)

Protocol document: