Improving Sleep in Nursing Homes

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00576927
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 79
• Arms: 2
• Duration (Months): 31

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Deprivation	Drug: Ramelteon; Drug: Placebo	Phase 4

Detailed Description

This study evaluates how well Ramelteon works by measuring sleep at night and during the day. After consenting and final determination of eligibility, participants will complete a baseline phase to assess usual sleep, as well as daytime alertness and activity , thinking and memory, walking and balance (among those who walk and/or stand), and mood. Sleep at night and during the day will be objectively assessed with wrist actigraphs in all subjects. Approximately half will also receive polysomnography to assess nighttime sleep. Subjects who sleep more than 75% of the time they are in bed will not continue in the study. Subjects that do not have improved sleep with the sleep hygiene program will be randomized to one of two treatment groups - one will receive the active drug along with the sleep hygiene intervention and the other will receive a placebo along with the sleep hygiene intervention. Following randomization, subjects will complete a brief run-in phase and then enter the treatment phase. Assessment of sleep and other measures will be repeated.

The primary hypotheses to be examined in this study are as follows:

Hypothesis 1: Subjects treated with ramelteon in addition to a sleep hygiene (SHI) will have improved sleep latency, and as a consequence, a significant increase in actigraphically measured sleep efficiency, compared to subjects treated with placebo plus a SHI.

Hypothesis 2: Subjects treated with ramelteon in addition to a SHI will sleep less and spend less time in bed during the day, be more engaged in daytime activities, and have better mood than subjects treated with placebo plus a SHI.

Hypothesis 3: Changes in daytime sleep, time in bed during the day, engagement in activities, and mood will be positively correlated with improved sleep efficiency among subjects receiving ramelteon in addition to a SHI.

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Sleep in Nursing Homes
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group1 SHI followed by Active Drug Ramelteon	Drug: Ramelteon; 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.; Other Names: Rozerem
Placebo Comparator: Group 2 SHI Followed by Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Number of Participants Meeting Good Sleep Latency Criteria [All assessment periods, up to one week]

   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.

Secondary Outcome Measures

1. Sleep Efficiency [All Assessment Phases, up to one week]

   % of time asleep holding time in bed constant (averaged over 3-5 nights)

2. Daytime Engagement Status [All Assessment Phases, up to one week]

   Trained research technicians observed the subjects behavior during assessment phases every 15 minutes for one full minute. Specific behavioral definitions were employed to record whether the subject was in or out of bed, awake or asleep (eyes closed with no purposeful movement for at least 60 consecutive seconds), actively engaged in an activity (reading, watching television, conversation, a specific group activity, etc), and whether any physical or verbal agitation was noted.

Other Outcome Measures

1. Daytime Sleep [All Assessment Phases, up to one week]

   As measured by percent of daytime behavioral observations observed asleep

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Emory University
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Patricia C Griffiths, PhD, Emory University, School of Medicine, Division of General Medicine and Geriatrics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Patricia C Griffiths, Principal Investigator, Emory University
• ClinicalTrials.gov Identifier: NCT00576927
• Other Study ID Numbers: IRB00000460; R01AG028769
• First Posted: Dec 19, 2007
• Last Update Posted: Aug 13, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by Patricia C Griffiths, Principal Investigator, Emory University: Sleep hygiene; Sleep latency; Elderly sleep; Nursing Home sleep
• Additional relevant MeSH terms: Sleep Deprivation

Study Results

Participant Flow

Recruitment Details	Subjects were long-stay residents of NHs in the Atlanta area who were > age 65. Potential subjects were initially screened using administrative data and medical record review. Potential subjects who do not meet any of the exclusion criteria after initial screening were approached for informed consent or proxy consent was obtained when applicable.
Pre-assignment Detail	Those for whom consent was obtained underwent a clinical assessment and baseline measures . Only subjects with 5-night average sleep latency > 20 minutes and/or sleep efficiency <80% were included . Subjects with severe sleep apnea were excluded and referred to their primary physician. Subjects unable to tolerate the actiwatches were excluded.

Arm/Group Title	All Subjects
Arm/Group Description
Period Title: Clinical Assessment
STARTED	79
COMPLETED	43
NOT COMPLETED	36
Period Title: Clinical Assessment
STARTED	43
COMPLETED	30
NOT COMPLETED	13
Period Title: Clinical Assessment
STARTED	30
COMPLETED	23
NOT COMPLETED	7
Period Title: Clinical Assessment
STARTED	23
COMPLETED	22
NOT COMPLETED	1
Period Title: Clinical Assessment
STARTED	22
COMPLETED	22
NOT COMPLETED	0
Period Title: Clinical Assessment
STARTED	22
COMPLETED	22
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Ramelteon	Placebo	Total
Arm/Group Description	6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.	6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.	Total of all reporting groups
Overall Participants	11	11	22
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	11 100%	11 100%	22 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	83.9 (6.8)	85.0 (8.9)	85.0 (7.5)
Sex: Female, Male (Count of Participants)
Female	8 72.7%	8 72.7%	16 72.7%
Male	3 27.3%	3 27.3%	6 27.3%
Region of Enrollment (participants) [Number]
United States	11 100%	11 100%	22 100%

Outcome Measures

1. Secondary Outcome

Title	Sleep Efficiency
Description	% of time asleep holding time in bed constant (averaged over 3-5 nights)
Time Frame	All Assessment Phases, up to one week

Outcome Measure Data

Analysis Population Description

Per protocol -- intention to treat - ITT - last carried forward.

Arm/Group Title	Ramelteon	Placebo
Arm/Group Description	6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.	6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
Measure Participants	11	11
Mean (Standard Deviation) [percentage of sleep]	76.5 (11.8)	73.8 (14.9)

2. Primary Outcome

Title	Number of Participants Meeting Good Sleep Latency Criteria
Description	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.
Time Frame	All assessment periods, up to one week

Outcome Measure Data

Analysis Population Description

30 subjects enrolled into the behavioral intervention. 4 subjects responded to the sleep hygiene intervention (SHI) arm and completed the study. 3 subjects were excluded for various reasons from the SHI arm. 23 subjects continued onto the placebo/SHI. 1 subject withdrew from that arm. From there,11 subjects received drug and 11 remained on placebo

Arm/Group Title	Ramelteon	Placebo
Arm/Group Description	6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.	6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
Measure Participants	11	11
Number [participants]	7 63.6%	6 54.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ramelteon, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.655
	Comments	p-value suspect because of sparse cell counts
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.46
	Confidence Interval	(2-Sided) 95%; 0.156 to 8.717
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Daytime Engagement Status
Description	Trained research technicians observed the subjects behavior during assessment phases every 15 minutes for one full minute. Specific behavioral definitions were employed to record whether the subject was in or out of bed, awake or asleep (eyes closed with no purposeful movement for at least 60 consecutive seconds), actively engaged in an activity (reading, watching television, conversation, a specific group activity, etc), and whether any physical or verbal agitation was noted.
Time Frame	All Assessment Phases, up to one week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ramelteon	Placebo
Arm/Group Description	6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.	6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
Measure Participants	11	11
Mean (Standard Deviation) [percentage of engaged observations]	54.6 (24.6)	54.6 (24.6)

4. Other Pre-specified Outcome

Title	Daytime Sleep
Description	As measured by percent of daytime behavioral observations observed asleep
Time Frame	All Assessment Phases, up to one week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ramelteon	Placebo
Arm/Group Description	6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.	6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
Measure Participants	11	11
Mean (Standard Deviation) [percentage of daytime sleep observations]	19.4 (23.1)	21.7 (29.0)

Adverse Events

Arm/Group Title	Ramelteon		Placebo
Arm/Group Description	6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.		6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
All Cause Mortality
	Ramelteon		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ramelteon		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Ramelteon		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.