Sleep DeprivationPhase 4NCT00576927

Improving Sleep in Nursing Homes

A Phase 4 study testing Ramelteon in people with Sleep Deprivation, run by Emory University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Sleep Deprivation
What is being tested?: Ramelteon
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 79 participants
Where: No sites listed yet
Study dates: Oct 2007to May 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

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

Who cannot join

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)

About this study

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.

Read the 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.

Conditions: Sleep Deprivation
Being tested: Ramelteon, Placebo
Keywords: Sleep hygiene, Sleep latency, Elderly sleep, Nursing Home sleep
Medical subject headings: Sleep Deprivation, Sleep Hygiene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RamelteonDrug
Also called Rozerem
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.
PlaceboDrug

Study groups in NCT00576927
Study group	Role	What they receive
Group1	Experimental	SHI followed by Active Drug Ramelteon Receives: Drug: Ramelteon
Group 2	Placebo comparator	SHI Followed by Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: All assessment periods, up to one week

Secondary outcomes (2)

Sleep Efficiency
% of time asleep holding time in bed constant (averaged over 3-5 nights)
Measured: All Assessment Phases, up to one week
Daytime Engagement Status
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.
Measured: All Assessment Phases, up to one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007May 2010

First posted19 Dec 2007 (estimated)
Study startOct 2007
Primary completionFeb 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sleep DeprivationStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00576927
Sponsor's protocol ID: IRB00000460
Other IDs: R01AG028769
Status last verified: Aug 2014
First submitted: 17 Dec 2007
Last updated: 13 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm
Recruiting
Effect of Sleep Extension in Prevention to Sleep Deprivation
Healthy
Not yet recruiting
Evolution of Sleep in Intensive Care Unit Patients
ICU, Sleep Deprivation
Active, not recruiting
The Effect of Sleep Deprivation and Recovery Sleep on Emotional Memory and Affective Reactivity
Sleep Deprivation, Sleep
Recruiting
Mind After Midnight
Suicidal Ideation, Circadian Rhythm Disorders

All Sleep Deprivation trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Sleep in Nursing Homes
ClinicalTrials.gov ID: NCT00576927
Acronym / sponsor ID: IRB00000460
Conditions: Sleep Deprivation
Keywords: Sleep hygiene, Sleep latency, Elderly sleep, Nursing Home sleep
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: Oct 2007
Primary completion: Feb 2010 (actual)
Study completion: May 2010 (actual)
First posted: 19 Dec 2007 (estimated)
Results: Posted 13 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group1	Experimental	Drug: RamelteonSHI followed by Active Drug Ramelteon
Group 2	Placebo comparator	Drug: PlaceboSHI Followed by Placebo

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RamelteonAlso: RozeremSubjects 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.	Drug	Group1
Placebo	Drug	Group 2

Primary outcome

Number of Participants Meeting Good Sleep Latency Criteria
Time frame: 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.

2 secondary outcomes

Sleep Efficiency
Time frame: All Assessment Phases, up to one week
Daytime Engagement Status
Time frame: All Assessment Phases, up to one week

Results and safety

Results posted to the registry on 13 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	79	43

Primary outcome: Number of Participants Meeting Good Sleep Latency Criteria

Time frame: All assessment periods, up to one week. Number. Unit: participants

Measure	Ramelteon n = 11	Placebo n = 11
Value	7	6

Ramelteon vs Placebo: Odds Ratio (OR): 1.46 (95% CI 0.156 to 8.717), p = 0.655, Chi-squared

Population analysed: 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

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ramelteon	0 of 11 (0%)	0 of 11 (0%)	Not reported
Placebo	0 of 11 (0%)	0 of 11 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Sleep Deprivation

Recruiting
Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm
Recruiting
Effect of Sleep Extension in Prevention to Sleep Deprivation
Healthy
Not yet recruiting
Evolution of Sleep in Intensive Care Unit Patients
ICU, Sleep Deprivation
Active, not recruiting
The Effect of Sleep Deprivation and Recovery Sleep on Emotional Memory and Affective Reactivity
Sleep Deprivation, Sleep
Recruiting
Mind After Midnight
Suicidal Ideation, Circadian Rhythm Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patricia C Griffiths, PhD principal investigator

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ramelteon in people with Sleep Deprivation, run by Emory University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Meeting Good Sleep Latency Criteria (time frame: All assessment periods, up to one week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00576927.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014; AzTrials last refreshed its copy on 27 Oct 2026.