Improving Sleep in Nursing Homes

NCT00576927 | Completed Phase 4 Results DMC

• 2 other identifiers: IRB00000460R01AG028769
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sleep Deprivation

Keywords

Sleep hygiene; Sleep latency; Elderly sleep; Nursing Home sleep

Outcome Measures

Primary Outcomes (1)

• Number of Participants Meeting Good Sleep Latency Criteria

  Sleep Latency Criteria for "Good Latency" measured by behavioral observations conducted every 10-15 minutes after 4pm until 11pm. Good latency is described as subject asleep in under 20 minutes on 51% of the nights observed in a week.

  All assessment periods, up to one week

Secondary Outcomes (2)

• Sleep Efficiency

  All Assessment Phases, up to one week

• Daytime Engagement Status

  All Assessment Phases, up to one week

Other Outcomes (1)

• Daytime Sleep

  All Assessment Phases, up to one week

Study Arms (2)

Group1

EXPERIMENTAL

SHI followed by Active Drug Ramelteon

Drug: Ramelteon

Group 2

PLACEBO COMPARATOR

SHI Followed by Placebo

Drug: Placebo

Interventions

Ramelteon DRUG

Subjects demonstrating low sleep efficiencies and prolonged sleep latencies, will be randomly assigned to continue to receive SHI accompanied by either placebo or Ramelteon (8 mg). Matching placebo will be obtained and the medication pre-packaged and ordered based on the randomization results.

Also known as: Rozerem

Group1

Placebo DRUG

Group 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• After initial screening and consenting, subjects with a 5-night average baseline sleep efficiency of less than or equal to 75% will be included

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• National Institutes of Health (NIH): collaborator

MeSH Terms

Conditions

Sleep Deprivation; Sleep Hygiene

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Health Behavior; Behavior

Limitations and Caveats

Low power to detect statistically significant effects of the interventions on outcomes; Inability to examine predictors of responsiveness because of the small sample size and the large number of predictors of response.

Results Point of Contact

• Title: Dr. Patricia Griffiths
• Organization: Emory University Division of General Medicine and Geriatrics

pcgriff@emory.edu

404-321-6111

Study Officials

• Patricia C Griffiths, PhD

  Emory University, School of Medicine, Division of General Medicine and Geriatrics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 19, 2007
• Study Start: October 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 13, 2014
• Results First Posted: August 13, 2014

Record last verified: 2014-08