Anthony Lequerica1, Neil Jasey2, Jaclyn N Portelli Tremont3, Nancy D Chiaravalloti4. 1. Kessler Foundation, West Orange, NJ; Department of Physical Medicine and Rehabilitation, Rutgers, New Jersey Medical School, Newark, NJ. Electronic address: alequerica@kesslerfoundation.org. 2. Kessler Institute for Rehabilitation, West Orange, NJ. 3. Robert Wood Johnson Medical School, Rutgers University, New Brunswick, NJ. 4. Kessler Foundation, West Orange, NJ; Department of Physical Medicine and Rehabilitation, Rutgers, New Jersey Medical School, Newark, NJ.
Abstract
OBJECTIVE: To investigate the effect of ramelteon on sleep and daytime functioning among individuals with traumatic brain injury (TBI). DESIGN: A double-blind, placebo-controlled study with a crossover design. SETTING: A research facility attached to an acute rehabilitation hospital. PARTICIPANTS: Individuals with TBI (N=13) complaining of sleep difficulties with a Pittsburgh Sleep Quality Index score >5. INTERVENTIONS: A nightly dosage of ramelteon (8 mg) was given over a period of 3 weeks. MAIN OUTCOME MEASURES: An actigraph and a daily sleep log were used to measure sleep/wake patterns. Daytime functioning was measured after 3 weeks of treatment using a computer-administrated neuropsychological test battery in conjunction with subjective questionnaires measuring mood, daytime sleepiness, and fatigue. RESULTS: A significant increase in objectively measured total sleep time and a small increase in sleep latency were observed after 3 weeks of treatment compared with placebo. Treatment also showed a significant increase in standardized neuropsychological test scores, with a particular improvement on an index of executive functioning. CONCLUSIONS: Preliminary evidence for the effectiveness of 8 mg of ramelteon taken nightly over a 3-week period was found in the treatment of sleep difficulties among individuals with TBI. Improvements in total sleep time and some aspects of cognitive functioning are discussed.
RCT Entities:
OBJECTIVE: To investigate the effect of ramelteon on sleep and daytime functioning among individuals with traumatic brain injury (TBI). DESIGN: A double-blind, placebo-controlled study with a crossover design. SETTING: A research facility attached to an acute rehabilitation hospital. PARTICIPANTS: Individuals with TBI (N=13) complaining of sleep difficulties with a Pittsburgh Sleep Quality Index score >5. INTERVENTIONS: A nightly dosage of ramelteon (8 mg) was given over a period of 3 weeks. MAIN OUTCOME MEASURES: An actigraph and a daily sleep log were used to measure sleep/wake patterns. Daytime functioning was measured after 3 weeks of treatment using a computer-administrated neuropsychological test battery in conjunction with subjective questionnaires measuring mood, daytime sleepiness, and fatigue. RESULTS: A significant increase in objectively measured total sleep time and a small increase in sleep latency were observed after 3 weeks of treatment compared with placebo. Treatment also showed a significant increase in standardized neuropsychological test scores, with a particular improvement on an index of executive functioning. CONCLUSIONS: Preliminary evidence for the effectiveness of 8 mg of ramelteon taken nightly over a 3-week period was found in the treatment of sleep difficulties among individuals with TBI. Improvements in total sleep time and some aspects of cognitive functioning are discussed.
Authors: Emerson M Wickwire; David M Schnyer; Anne Germain; Scott G Williams; Christopher J Lettieri; Ashlee B McKeon; Steven M Scharf; Ryan Stocker; Jennifer Albrecht; Neeraj Badjatia; Amy J Markowitz; Geoffrey T Manley Journal: J Neurotrauma Date: 2018-08-24 Impact factor: 5.269
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