LOCK Sleep Program for Dementia

(40Winks Trial)

Recruiting at 2 trial locations

Overseen By Brian Cox, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama, Tuscaloosa

Disqualifiers: Untreated OSA, Parkinson's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

456 Participants Needed

Trial Summary

What is the purpose of this trial?

This study seeks to improve clinical outcomes for an important, growing, and vulnerable population-nursing home residents with Alzheimer's disease or related dementias-by testing an evidence-based intervention to improve these residents' sleep. It will also examine the implementation and sustainment of this intervention.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the LOCK Sleep Program treatment for dementia?

The LOCK Sleep Program is based on evidence supporting teamwork and systematic observation, which has been shown to improve sleep quality in nursing home residents with dementia. Additionally, similar interventions focusing on sleep hygiene and environmental changes have been effective in improving sleep for people with dementia. ^{1 2 3 4 5}

Is the LOCK Sleep Program for Dementia safe for humans?

The LOCK Sleep Program is a non-drug approach aimed at improving sleep in people with dementia, and there is no specific safety data indicating harm. It focuses on teamwork and observation to enhance sleep quality, which suggests it is generally safe for human use. ^{1 2 6 7 8}

How is the LOCK Sleep Program treatment different from other treatments for sleep disturbances in dementia?

The LOCK Sleep Program is unique because it focuses on improving sleep through a strengths-based learning approach, systematic observation, and relationship-based teamwork among nursing home staff, rather than relying on medications or light therapy. This program emphasizes teamwork and efficiency to create a better sleep environment for dementia patients. ^{2 3 8 9 10}

Research Team

Lynn Snow, PhD

Principal Investigator

The University of Alabama

Eligibility Criteria

This trial is for nursing home residents aged 50 or older who have Alzheimer's disease or related dementias and are experiencing sleep problems, as identified by their caregivers.

Inclusion Criteria

I am over 50, live in a nursing home, have Alzheimer's or related dementia, and have sleep problems.

Exclusion Criteria

Residents who have a persistent bilateral resting tremor or paralysis in both arms (a subset of persons with Parkinson's disease and related significant tremor-causing diagnoses) due to actigraph measurement inaccuracies

I am at high risk for sleep apnea but not currently treated due to measurement issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Control

Each nursing home serves as its own control. Control data will be collected for 1 week before the intervention begins.

1 week

Intervention

The intervention arm includes a ten-week active intervention phase using the LOCK-based sleep program.

10 weeks

Sustainment

A five-week sustainment phase to examine the sustainability of the LOCK sleep program.

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention.

4 weeks

Treatment Details

Interventions

• LOCK Sleep Program
• No intervention (control period/baseline data collection)

Trial Overview The study tests the LOCK Sleep Program designed to enhance sleep quality in dementia patients against a period with no intervention. It aims to assess both the effectiveness of the program and how it can be maintained over time.

Participant Groups

Group I: Intervention (all NHs receive the intervention): Experimental Treatment 1 Intervention

The intervention arm includes a ten-week active intervention phase, then a five-week sustainment phase.

Group II: Control (each NH acts as its own control): Experimental Treatment 1 Intervention

Each nursing home serves as its own control. Control data will be collected for 1 week (then the intervention will begin).

Who Is Running the Clinical Trial?

University of Alabama, Tuscaloosa

Lead Sponsor

Trials

49

Recruited

17,900+

University of Massachusetts, Lowell

Collaborator

Trials

21

Recruited

10,300+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Findings from Research

This study is testing a comprehensive 16-week intervention designed to reduce sleep problems in people with dementia living in nursing homes, involving 24 facilities across Germany.

The intervention includes training for nursing staff and the introduction of 'sleep nurses' to implement sleep-promoting strategies, aiming to improve not only the quality of sleep for residents but also their overall quality of life and reduce the burden on caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a multi-component, non-pharmacological intervention to prevent and reduce sleep disturbances in people with dementia living in nursing homes (MoNoPol-sleep): study protocol for a cluster-randomized exploratory trial. Dichter, MN., Berg, A., Hylla, J., et al.[2021]

The LOCK program is an evidence-based intervention designed to improve sleep for nursing home residents with dementia, addressing common disturbances caused by nursing home routines.

This study will evaluate the effectiveness of the LOCK intervention over a 4-year period in 24 nursing homes, measuring its impact on sleep quality and secondary outcomes like medication use and daily living activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing sleep quality for nursing home residents with dementia: a pragmatic randomized controlled trial of an evidence-based frontline huddling program. Snow, AL., Loup, J., Morgan, RO., et al.[2022]

The Sleep Education Program (SEP) was successfully implemented in adult family homes, showing that staff-caregivers could effectively develop and apply individualized sleep plans for residents with dementia.

Residents who participated in the SEP experienced significant improvements in sleep quality, including increased total sleep time and reduced nocturnal disturbances, compared to those receiving usual care, indicating the program's potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a sleep education program for older adults with dementia living in adult family homes. McCurry, SM., LaFazia, DM., Pike, KC., et al.[2021]

Training caregivers to implement sleep hygiene recommendations for Alzheimer's disease patients is feasible and leads to significant improvements in sleep scheduling and daytime activity.

Caregivers who received specific guidance were much more successful in helping patients maintain consistent bedtimes and reduce daytime napping compared to those who only received general education, highlighting the need for active support in implementing these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training caregivers to change the sleep hygiene practices of patients with dementia: the NITE-AD project. McCurry, SM., Gibbons, LE., Logsdon, RG., et al.[2019]

Optimal sleep is crucial for the health and recovery of older patients with dementia in hospitals, as poor sleep can worsen their condition and potentially accelerate dementia progression.

Nursing staff can implement evidence-based strategies, such as person-centred sleep care and environmental adaptations, to help improve sleep quality for these patients, which may contribute to better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting older people with dementia to sleep well while in hospital. Ury, E.[2021]

Nearly half of seniors over 65 living at home and two-thirds in nursing homes experience sleep disorders, which can lead to serious cognitive issues that may be mistaken for dementia.

Untreated sleep disorders in older adults can worsen cognitive and behavioral symptoms in dementia patients, increase the risk of nighttime injuries, and create significant stress for caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep, Cognition and Dementia. Porter, VR., Buxton, WG., Avidan, AY.[2022]

People with dementia often experience significant changes in their sleep patterns, including increased difficulty falling asleep and staying asleep, which can lead to daytime napping and behavioral issues like 'sundowning'.

While sleep hygiene practices can help improve sleep quality, they can be challenging for caregivers to implement, and pharmacological treatments may be effective for some symptoms but carry risks that need careful consideration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Dysfunction in Alzheimer's Disease and Other Dementias. McCurry, SM., Ancoli-Israel, S.[2020]

Recent reviews and studies indicate that there are currently no proven effective treatments for sleep disorders in dementia, including pharmacological options like melatonin and psychotropic medications.

Preliminary research suggests potential for nonpharmacological interventions, but more well-designed controlled trials are necessary to identify safe and effective treatment strategies for sleep disturbances in dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The management of sleep disorders in dementia: an update. Kinnunen, KM., Vikhanova, A., Livingston, G.[2021]

A study involving elderly patients with dementia showed that exposure to bright ambient light (2500 lux) in the morning significantly improved sleep efficiency by 41.9% and increased total sleep time by 141 minutes after 4 weeks of intervention.

The bright light therapy also advanced sleep onset by 60-84 minutes and delayed sleep offset by 57-79 minutes, indicating its effectiveness in stabilizing circadian rhythms and reducing sleep disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambient bright lighting in the morning improves sleep disturbances of older adults with dementia. Liu, CR., Liou, YM., Jou, JH.[2022]

Bright light exposure treatment for six elderly individuals with dementia showed positive effects, with three subjects experiencing increased daytime wakefulness and/or improved sleep during the night.

All participants exhibited a reduction in abnormal behavior episodes around bedtime, indicating that bright light treatment can effectively address sleep-wake disturbances in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light treatment for sleep-wake disturbances in aged individuals with dementia. Koyama, E., Matsubara, H., Nakano, T.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of a multi-component, non-pharmacological intervention to prevent and reduce sleep disturbances in people with dementia living in nursing homes (MoNoPol-sleep): study protocol for a cluster-randomized exploratory trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Enhancing sleep quality for nursing home residents with dementia: a pragmatic randomized controlled trial of an evidence-based frontline huddling program. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Development and evaluation of a sleep education program for older adults with dementia living in adult family homes. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Training caregivers to change the sleep hygiene practices of patients with dementia: the NITE-AD project. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Supporting older people with dementia to sleep well while in hospital. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Sleep, Cognition and Dementia. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Sleep Dysfunction in Alzheimer's Disease and Other Dementias. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

The management of sleep disorders in dementia: an update. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Ambient bright lighting in the morning improves sleep disturbances of older adults with dementia. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Bright light treatment for sleep-wake disturbances in aged individuals with dementia. [2015]