Trial Outcomes & Findings for Improving Sleep in Nursing Homes (NCT NCT00576927)

Last Updated: 2014-08-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

79 participants

Primary outcome timeframe

All assessment periods, up to one week

Results posted on

2014-08-13

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	All Subjects
Clinical Assessment STARTED	79
Clinical Assessment COMPLETED	43
Clinical Assessment NOT COMPLETED	36
Baseline STARTED	43
Baseline COMPLETED	30
Baseline NOT COMPLETED	13
Sleep Hygiene Behavioral Intervention STARTED	30
Sleep Hygiene Behavioral Intervention COMPLETED	23
Sleep Hygiene Behavioral Intervention NOT COMPLETED	7
Sleep Hygiene With the Placebo STARTED	23
Sleep Hygiene With the Placebo COMPLETED	22
Sleep Hygiene With the Placebo NOT COMPLETED	1
Sleep Hygiene With Study Drug STARTED	22
Sleep Hygiene With Study Drug COMPLETED	22
Sleep Hygiene With Study Drug NOT COMPLETED	0
Randomization 1:1 Placebo or Active Drug STARTED	22
Randomization 1:1 Placebo or Active Drug COMPLETED	22
Randomization 1:1 Placebo or Active Drug NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	All Subjects
Clinical Assessment Lack of Efficacy	24
Clinical Assessment Death	1
Clinical Assessment Withdrawal by Subject	10
Clinical Assessment Physician Decision	1
Baseline Physician Decision	9
Baseline Medication Change by PCP of subject	1
Baseline Withdrawal by Subject	3
Sleep Hygiene Behavioral Intervention Responded to intervention	4
Sleep Hygiene Behavioral Intervention Death	1
Sleep Hygiene Behavioral Intervention Medication Change by PCP for subject	1
Sleep Hygiene Behavioral Intervention Withdrawal by Subject	1
Sleep Hygiene With the Placebo Withdrawal by Subject	1

Baseline Characteristics

Improving Sleep in Nursing Homes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ramelteon n=11 Participants 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.	Placebo n=11 Participants 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 n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Age, Continuous	83.9 years STANDARD_DEVIATION 6.8 • n=5 Participants	85.0 years STANDARD_DEVIATION 8.9 • n=7 Participants	85.0 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: All assessment periods, up to one week

Population: 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

Outcome measures

Outcome measures
Measure	Ramelteon n=11 Participants 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.	Placebo n=11 Participants 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.
Number of Participants Meeting Good Sleep Latency Criteria	7 participants	6 participants

SECONDARY outcome

Timeframe: All Assessment Phases, up to one week

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

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

Outcome measures

Outcome measures
Measure	Ramelteon n=11 Participants 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.	Placebo n=11 Participants 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.
Sleep Efficiency	76.5 percentage of sleep Standard Deviation 11.8 • Interval 300.0 to 400.0	73.8 percentage of sleep Standard Deviation 14.9 • Interval 300.0 to 400.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ramelteon n=11 Participants 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.	Placebo n=11 Participants 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.
Daytime Engagement Status	54.6 percentage of engaged observations Standard Deviation 24.6	54.6 percentage of engaged observations Standard Deviation 24.6

OTHER_PRE_SPECIFIED outcome

Timeframe: All Assessment Phases, up to one week

As measured by percent of daytime behavioral observations observed asleep

Outcome measures

Outcome measures
Measure	Ramelteon n=11 Participants 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.	Placebo n=11 Participants 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.
Daytime Sleep	19.4 percentage of daytime sleep observations Standard Deviation 23.1	21.7 percentage of daytime sleep observations Standard Deviation 29.0

Adverse Events

Ramelteon

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Patricia Griffiths

Emory University Division of General Medicine and Geriatrics

Phone: 404-321-6111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place