Phase 4
N=79
Improving Sleep in Nursing Homes
Sleep Deprivation
Bottom Line
View on ClinicalTrials.gov: NCT00576927 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Number of Participants Meeting Good Sleep Latency Criteria — 7; 6 participants — p=0.655
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ramelteon (Drug); Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Meeting Good Sleep Latency Criteria |
7; 6 | 0.655 |
| SECONDARY Sleep Efficiency |
76.5; 73.8 | — |
| SECONDARY Daytime Engagement Status |
54.6; 54.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- After initial screening and consenting, subjects with a 5-night average baseline sleep efficiency of less than or equal to 75% will be included
Exclusion Criteria
- Less than 65 yrs old
- Bedbound
- Resided in NH for less than two months
- Patients on Medicare Part A skilled Benefit(anticipated short length stay) - Terminal Illness
- Unstable psychotropic drug regimen (addition, discontinuation, or change of dosage of any psychotropic drug in the prior two weeks) - Use of hypnotic, antihistamine, or benzodiazepine more than once per week during the two weeks before screening
- Use of drugs that could potentially inhibit the metabolism of Ramelteon (ie: fluvoxamine, ketoconazole, fluconazole)
- Use of Drugs that induce the metabolism of Ramelteon (ie: rifampin)
Data sourced from ClinicalTrials.gov (NCT00576927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.