InsomniaSLUMBERNCT03327324

Improving Sleep Using Mentored Behavioral and Environmental Restructuring

A study testing Sleep Using Mentored Behavioral and Environmental Restructuring in people with Insomnia, run by NYU Langone Health at 1 site in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Insomnia
What is being tested?: Sleep Using Mentored Behavioral and Environmental Restructuring
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteUnited States
Study dates: 27 Mar 2018to 23 Feb 2021
Phase: Interventional
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

living in the unit of intervention,
ability to communicate and follow simple commands,
English- or Spanish-speaking,
capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.

Who cannot join

Does not have capacity and does not show enthusiasm for the research
Does not have capacity and does not have a proxy.
obtunded or comatose state,
inability to communicate verbally,
inability to consent and without surrogate
non-English and non-Spanish speaking. In keeping with QI strategies, all residents will be exposed to the environmental aspects of the intervention, as these strategies represent clinically proven non-experimental behavioral strategies with no perceptible harm.

Trial locations and contacts

1 site in 1 country.

United States1 site

New York University School of Medicine
New York, New York, 10016

Other trials in United States

About this study

The goal of this study is to test potential functional/psychosocial benefits of improved sleep using a program designed to teach nursing facility staff to improve sleep promoting strategies and environment for nursing home residents. Sleep disturbances are quite common in skilled nursing facilities and affect as many as 69% of residents while staff do not fully understand how to improve sleep without using medications. Medications for sleep are commonly used as first-line therapy for older adults but this is problematic because these medications can lead to greater problems with thinking, more frequent falls, and even worse sleep over time. In addition, poor sleep can lead to depressed mood, greater trouble with thinking and memory, worse pain, and greater need for help with daily activities.

Read the detailed description

This is a study to test the effects of improved sleep quality on downstream functional/psychosocial outcomes.

Conditions: Insomnia
Being tested: Sleep Using Mentored Behavioral and Environmental Restructuring
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

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

Sleep Using Mentored Behavioral and Environmental RestructuringBehavioural
Also called SLUMBER
SLUMBER is a non-pharmacological intervention program, delivered by providing mentoring to facility staff who work directly with residents. SLUMBER focuses on detecting sleep-disruptive factors including: nighttime noise and patient behaviors associated with poor sleep quality; disruptions caused by nighttime caregiving; daytime inactivity; and limited light exposure. In this model, staff-delivered interventions to improve these factors improve sleep quality thereby creating opportunities to test the impact of improving sleep quality (measured by actigraphy) on mood (depression and anxiety), pain, cognitive function, functional ability, and observed activity levels.

Study groups in NCT03327324
Study group	Role	What they receive
F1U1	Experimental	Sequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability. Receives: Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring
F1U2	Experimental	Sequence 2 (Facility 1/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 33 Month Sustainability Receives: Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring
F2U2	Experimental	Sequence 3 (Facility 2/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 27 Month Sustainability Receives: Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring
F2U3	Experimental	Sequence 4 (Facility 2/Unit 3): Baseline, then 3 Month SLUMBER Intervention, then 21 Month Sustainability Receives: Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring
F2U4	Experimental	Sequence 5 (Facility 2/Unit 4): Baseline, then 3 Month SLUMBER Intervention, then 15 Month Sustainability Receives: Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring
F3U1	Experimental	Sequence 6 (Facility 3/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 9 Month Sustainability Receives: Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring

What is being measured

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

Sleep Efficiency (SE)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
Measured: Baseline
Sleep Efficiency (SE)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
Measured: Post-Treatment (Month 6 Post-Baseline)
Sleep Efficiency (SE)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
Measured: Month 9 Post-Baseline
Nighttime Total Awake Time
Data will be obtained from antigraphy analysis.
Measured: Baseline
Nighttime Total Awake Time
Data will be obtained from antigraphy analysis.
Measured: Post-Treatment (Month 6 Post-Baseline)
Nighttime Total Awake Time
Data will be obtained from antigraphy analysis.
Measured: Month 9 Post-Baseline
Daytime Sleeping (Napping) Time
Wrist device / actigraphy will be used to measure sleep/wake time.
Measured: Baseline
Daytime Sleeping (Napping) Time
Wrist device / actigraphy will be used to measure sleep/wake time.
Measured: Post-Treatment (Month 6 Post-Baseline)
Daytime Sleeping (Napping) Time
Wrist device / actigraphy will be used to measure sleep/wake time.
Measured: Month 9 Post-Baseline
Score on Pittsburgh Sleep Quality Index (PSQI)
PSQI contains 19 self-rated questions. The 19 questions are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The total score range is 0-21; the higher the score, the greater the difficulties in all areas.
Measured: Month 9 Post-Baseline
Brief Anxiety and Depression Scale (BADS) Questionnaire Score
BADS is a brief screening tool for mood impairment developed for older adults. It consists of 8 questions, answered 0 (no), 1(somewhat), or 2 (yes). The total score range is 0-16; the higher the score, the higher the level of mood impairment
Measured: Month 9 Post-Baseline
Score on Brief Cognitive Assessment Tool (BCAT)
BCAT is a multi-domain cognitive instrument that assesses orientation, verbal recall, visual recognition, visual recall, attention, abstraction, language, executive functions, and visuo-spatial processing in adult and older adult populations. It consists of 21 items. The total score range is 0-50; the higher the score, the more normal the level of cognitive functioning and independent living.
Measured: Month 9 Post-Baseline

Timeline

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

27 Mar 201823 Feb 2021

First posted31 Oct 2017
Study start27 Mar 2018
Primary completion23 Feb 2021
Study completion23 Feb 2021

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe 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 N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03327324
Sponsor's protocol ID: 17-00338
Other IDs: 1R01NR016461-01A1
Acronym: SLUMBER
Status last verified: Jan 2023
First submitted: 25 Oct 2017
Last updated: 8 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Chodosh J, Mitchell MN, Cadogan M, Brody AA, Alessi CA, Hernandez DE, Mangold M, Martin JL. Improving sleep using mentored behavioral and environmental restructuring (SLUMBER): A randomized stepped-wedge design trial to evaluate a comprehensive sleep intervention in skilled nursing facilities. Contemp Clin Trials. 2023 Mar;126:107107. doi: 10.1016/j.cct.2023.107107. Epub 2023 Jan 27.
PubMed 36716989

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Sleep Using Mentored Behavioral and Environmental Restructuring
ClinicalTrials.gov ID: NCT03327324
Acronym / sponsor ID: SLUMBER / 17-00338
Conditions: Insomnia
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
Study start: 27 Mar 2018 (actual)
Primary completion: 23 Feb 2021 (actual)
Study completion: 23 Feb 2021 (actual)
First posted: 31 Oct 2017 (actual)
Results: Posted 8 Feb 2023

Clinical summary

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

Detailed description

This is a study to test the effects of improved sleep quality on downstream functional/psychosocial outcomes.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
F1U1	Experimental	Behavioral: Sleep Using Mentored Behavioral and Environmental RestructuringSequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability.
F1U2	Experimental	Behavioral: Sleep Using Mentored Behavioral and Environmental RestructuringSequence 2 (Facility 1/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 33 Month Sustainability
F2U2	Experimental	Behavioral: Sleep Using Mentored Behavioral and Environmental RestructuringSequence 3 (Facility 2/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 27 Month Sustainability
F2U3	Experimental	Behavioral: Sleep Using Mentored Behavioral and Environmental RestructuringSequence 4 (Facility 2/Unit 3): Baseline, then 3 Month SLUMBER Intervention, then 21 Month Sustainability
F2U4	Experimental	Behavioral: Sleep Using Mentored Behavioral and Environmental RestructuringSequence 5 (Facility 2/Unit 4): Baseline, then 3 Month SLUMBER Intervention, then 15 Month Sustainability
F3U1	Experimental	Behavioral: Sleep Using Mentored Behavioral and Environmental RestructuringSequence 6 (Facility 3/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 9 Month Sustainability

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

living in the unit of intervention,
ability to communicate and follow simple commands,
English- or Spanish-speaking,
capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.

Key exclusion criteria (6 listed)

Does not have capacity and does not show enthusiasm for the research
Does not have capacity and does not have a proxy.
obtunded or comatose state,
inability to communicate verbally,
inability to consent and without surrogate

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
Sleep Using Mentored Behavioral and Environmental RestructuringAlso: SLUMBERSLUMBER is a non-pharmacological intervention program, delivered by providing mentoring to facility staff who work directly with residents. SLUMBER focuses on detecting sleep-disruptive factors including: nighttime noise and patient behaviors associated with poor sleep quality; disruptions caused by nighttime caregiving; daytime inactivity; and limited light exposure. In this model, staff-delivered interventions to improve these factors improve sleep quality thereby creating opportunities to test the impact of improving sleep quality (measured by actigraphy) on mood (depression and anxiety), pain, cognitive function, functional ability, and observed activity levels.	Behavioural	F1U1, F1U2, F2U2, F2U3, F2U4, F3U1

Primary outcome

Sleep Efficiency (SE)
Time frame: Baseline
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
Sleep Efficiency (SE)
Time frame: Post-Treatment (Month 6 Post-Baseline)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
Sleep Efficiency (SE)
Time frame: Month 9 Post-Baseline
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
Nighttime Total Awake Time
Time frame: Baseline
Data will be obtained from antigraphy analysis.
Nighttime Total Awake Time
Time frame: Post-Treatment (Month 6 Post-Baseline)
Data will be obtained from antigraphy analysis.
Nighttime Total Awake Time
Time frame: Month 9 Post-Baseline
Data will be obtained from antigraphy analysis.
Daytime Sleeping (Napping) Time
Time frame: Baseline
Wrist device / actigraphy will be used to measure sleep/wake time.
Daytime Sleeping (Napping) Time
Time frame: Post-Treatment (Month 6 Post-Baseline)
Wrist device / actigraphy will be used to measure sleep/wake time.
Daytime Sleeping (Napping) Time
Time frame: Month 9 Post-Baseline
Wrist device / actigraphy will be used to measure sleep/wake time.
Score on Pittsburgh Sleep Quality Index (PSQI)
Time frame: Month 9 Post-Baseline
PSQI contains 19 self-rated questions. The 19 questions are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The total score range is 0-21; the higher the score, the greater the difficulties in all areas.
Brief Anxiety and Depression Scale (BADS) Questionnaire Score
Time frame: Month 9 Post-Baseline
BADS is a brief screening tool for mood impairment developed for older adults. It consists of 8 questions, answered 0 (no), 1(somewhat), or 2 (yes). The total score range is 0-16; the higher the score, the higher the level of mood impairment
Score on Brief Cognitive Assessment Tool (BCAT)
Time frame: Month 9 Post-Baseline
BCAT is a multi-domain cognitive instrument that assesses orientation, verbal recall, visual recognition, visual recall, attention, abstraction, language, executive functions, and visuo-spatial processing in adult and older adult populations. It consists of 21 items. The total score range is 0-50; the higher the score, the more normal the level of cognitive functioning and independent living.

Results and safety

Results posted to the registry on 8 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
F1U1	18	18
F1U2	20	17
F2U2	9	9
F2U3	10	9
F2U4	15	13
F3U1	20	14

Primary outcome: Sleep Efficiency (SE)

Time frame: Baseline. Mean (95% Confidence Interval). Unit: percentage of time in bed

Measure	Resident of the Skilled Nursing Facility n = 52
Value	76.1 (71.83 to 80.38)

Population analysed: Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure.

Primary outcome: Sleep Efficiency (SE)

Time frame: Post-Treatment (Month 6 Post-Baseline). Mean (95% Confidence Interval). Unit: percentage of time in bed

Measure	Resident of the Skilled Nursing Facility n = 52
Value	75.69 (70.89 to 80.49)

Population analysed: Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure.

Primary outcome: Sleep Efficiency (SE)

Time frame: Month 9 Post-Baseline. Mean (95% Confidence Interval). Unit: percentage of time in bed

Measure	Resident of the Skilled Nursing Facility n = 52
Value	75.61 (70.05 to 81.18)

Population analysed: Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure.

Primary outcome: Nighttime Total Awake Time

Time frame: Baseline. Mean (95% Confidence Interval). Unit: Minutes

Measure	Resident of the Skilled Nursing Facility n = 52
Value	11.54 (9.92 to 13.15)

Population analysed: Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Resident of the Skilled Nursing Facility	0 of 110 (0%)	0 of 110 (0%)	9 of 110

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36716989Chodosh J, Mitchell MN, Cadogan M, Brody AA, Alessi CA, Hernandez DE, Mangold M, Martin JL. Improving sleep using mentored behavioral and environmental restructuring (SLUMBER): A randomized stepped-wedge design trial to evaluate a comprehensive sleep intervention in skilled nursing facilities. Contemp Clin Trials. 2023 Mar;126:107107. doi: 10.1016/j.cct.2023.107107. Epub 2023 Jan 27.

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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.

Joshua Chodosh, MD principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Using Mentored Behavioral and Environmental Restructuring in people with Insomnia, run by NYU Langone Health at 1 site in United States.

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 4 inclusion and 6 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2023). 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?

Sleep Efficiency (SE) (time frame: Baseline). The study lists 12 primary outcomes in all. 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 NCT03327324, which also lists 1 linked publication.

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 8 Feb 2023.