drugset / Trial / NCT00576927

Improving Sleep in Nursing Homes

NCT00576927

RandomizedCrossoverQuadruple-blindTreatment

Summary

Older people living in nursing homes do not sleep very well for many reasons. Sleep disorders such as sleep apnea (when someone briefly stops breathing during sleep), and night time urination, along with the problems caused by the nighttime environment of the nursing home, such as noise and disruptive care routines can all contribute. Poor sleep can lead to other health problems or make existing health problems worse. This study will evaluate how well a sleep hygiene intervention and a medication for sleep (ramelteon (Rozerem)) work to improve sleep in nursing home residents with poor sleep. Ramelteon is FDA approved and has been tested in older adults living in the community, but not in older adults living in nursing homes. We expect sleep to improve on the study drug along with the sleep hygiene intervention, in comparison to placebo along with the sleep hygiene intervention. Based on adverse events reported in previous samples of older subjects, we expect the study drug to cause few side effects.

Timeline

Start
2007-10
Primary completion
2010-02
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ramelteon Unknown 8 mg

Indications

No indication recorded.