Nighttime agitation causes suffering for people with dementia, distresses caregivers, and often results in prescriptions for harmful antipsychotic medications. A sleep disorder, restless legs syndrome (RLS), may be causing nighttime agitation. The study will investigate if treatment of RLS with the FDA-approved medication, gabapentin enacarbil (Horizant®), improves sleep and reduces nighttime agitation, restless legs syndrome symptoms, and the use of antipsychotic medications.
The NightRest research study is supported by the National Institute on Aging of the National Institutes of Health under Award Number R01AG051588 and is in collaboration with Center for Excellence in Long Term Care.
The eight-week, double-blind, randomized control trial will include 136 residents with dementia, nighttime agitation, and RLS in long-term care settings in Central Texas. Residents will receive either gabapentin enacarbil (Horizant®) or a placebo. A 2-month post-trial follow-up will assess whether there is a decrease in antipsychotic medications for nighttime agitation behaviors in people with dementia.
Benefits of Participation
- Diagnosis of a treatable condition (RLS) that causes discomfort using a new tool that is not currently available to doctors.
- A tailored treatment for nighttime agitation behaviors that may result in improved quality of sleep, less agitation, and less discomfort.
- Blood tests that may identify abnormalities or changes in health.
- Daily visits by the study nurse that may result in early identification of health problems.
- An individual plan to reduce nighttime agitation behaviors developed by our multidisciplinary team and shared with participants’ physicians.
- Visits and interaction with study staff.
- Contribution to important research that will help improve the lives of others.
How to Participate
Please schedule a time to discuss how your facility or family member can participate by calling 512-475-7505 or emailing firstname.lastname@example.org. For grant information visit the Nighttime Study clinical trial page.