Sleep and Exercise for Alzheimer's Disease

(CASE Trial)

Recruiting at 1 trial location

Overseen By Debbie Chung, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Exercise inability, Device use inability, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how sleep and exercise influence the risk of dementia over time. It involves different groups: some will focus only on sleep, others only on exercise, and some on both. Participants will use devices like the DREEM 2 Headband (a sleep tracking device) and a Fitbit (a wristwatch activity tracker) to monitor their sleep and activity. Individuals who have experienced issues with memory, concentration, or processing information and can perform mild exercise might be a good fit for this trial. As an unphased study, this trial offers a unique opportunity to contribute to understanding lifestyle impacts on dementia risk.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the DREEM 2 Headband and Exercise Routine are safe?

Research has shown that the Dreem 2 headband is generally well-tolerated by older adults. Studies with participants around 70 years old found no major side effects from using the headband, suggesting it is safe for tracking sleep patterns.

Evidence indicates that regular physical activity is both safe and beneficial. The World Health Organization advises adults to engage in 150 to 300 minutes of moderate exercise each week. This level of activity is considered safe and can help reduce the risk of dementia.

Overall, both the Dreem 2 headband and the exercise routine appear safe based on past research. However, it is important to consult a healthcare provider before starting any new program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how combining exercise and improved sleep can impact Alzheimer's disease. While current treatments for Alzheimer's mainly involve medications like donepezil or memantine that target brain chemicals, this trial focuses on lifestyle changes. The unique aspect here is the use of the DREEM 2 headband to enhance sleep quality, paired with a structured exercise routine. By studying these non-drug interventions, researchers hope to find sustainable, side-effect-free ways to improve cognitive function and quality of life for those with Alzheimer's.

What evidence suggests that this trial's treatments could be effective for reducing dementia risk?

Research has shown that regular exercise can help reduce the risk of Alzheimer's disease. Studies have found that older adults who stay active are more likely to maintain sharp mental abilities. One study suggested that exercise can slow memory and thinking problems in people with Alzheimer's. Additionally, exercise might lower the chance of developing dementia by up to 20%. In this trial, participants in the Exercise Only Group will follow a workout routine twice a week for 12 weeks. Meanwhile, the DREEM 2 headband, used in the Sleep Only Group, tracks sleep, though current data does not clearly show its impact on reducing dementia risk. Participants in the Exercise and Sleep Group will combine both interventions, as good sleep is generally considered beneficial for brain health. ^{1 2 6 7 8}

Who Is on the Research Team?

Azizi A Seixas, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for individuals experiencing memory, concentration, or information processing issues who can do mild exercise and wear a DREEM 2 Headband and Fitbit watch. They must be able to handle a digital device and perform the Everlywell biomarker test. Participants should speak English and consent willingly.

Inclusion Criteria

I am mentally capable and agree to participate.

I can do the Everlywell biomarker test.

I can use a smartphone, tablet, or computer.

Exclusion Criteria

You are not allowed to do light exercise or have difficulty doing so.

Unable or unwilling to consent for any reason.

Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in sleep and/or exercise interventions for 12 weeks

12 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DREEM 2 Headband
• Exercise Routine
• Fitbit

Trial Overview The study examines how sleep quality and an exercise routine might influence dementia risk over time using tools like the DREEM 2 Headband to monitor sleep patterns and a Fitbit watch to track activity levels.

How Is the Trial Designed?

Group I: Sleep Only Group Experimental Treatment 1 Intervention

Participants in this group will wear the DREEM 2 headband for 12 weeks.

Group II: Exercise Only Group Active Control 1 Intervention

Participants in this group will workout twice a week for 12 weeks.

Group III: Exercise and Sleep Group Active Control 2 Interventions

Participants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Dreem

Industry Sponsor

Trials

7

Recruited

280+

Shipley Foundation

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

A review of 14 studies on exercise and Alzheimer's disease found that exercise can significantly improve daily functioning and performance in patients, enhancing their ability to carry out daily activities.

Exercise also positively impacts neuropsychiatric symptoms and various cognitive functions, including sustained attention and visual memory, suggesting it may be a valuable intervention for managing Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the Benefits of Exercise for Alzheimer's Disease? A Systematic Review of the Past 10 Years. Hernández, SS., Sandreschi, PF., da Silva, FC., et al.[2018]

A multimodal exercise program over 6 months significantly improved sleep disturbances and performance in instrumental activities of daily living for patients with Alzheimer's and Parkinson's diseases, as shown in a study of 77 participants.

In contrast, control groups showed either maintenance or worsening of these conditions, highlighting the potential benefits of regular physical exercise for cognitive health in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a multimodal exercise program on sleep disturbances and instrumental activities of daily living performance on Parkinson's and Alzheimer's disease patients. Nascimento, CM., Ayan, C., Cancela, JM., et al.[2015]

A home-based exercise program for patients with Alzheimer's Disease (AD) showed good adherence and a trend towards improved functional performance, particularly in hand function and lower extremity strength, after 6 and 12 weeks.

Despite the positive trends in functional performance, there were also indications of worse depression and lower quality of life ratings among participants, suggesting the need for further research to optimize the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a home-based exercise program in the treatment of Alzheimer's disease: the Maximizing Independence in Dementia (MIND) study. Steinberg, M., Leoutsakos, JM., Podewils, LJ., et al.[2022]

Physical exercise may offer significant physical and mental benefits for individuals with Alzheimer's disease (AD), potentially addressing some of the metabolic and neuropathological changes associated with the condition.

The article reviews clinical studies that support the role of structured physical exercise programs in the treatment of AD, providing guidance on how to effectively prescribe these programs for older adults with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of physical exercise for older adults with Alzheimer's disease. Pérez, CA., Cancela Carral, JM.[2008]

This systematic review analyzed 23 studies on the effects of physical activity in Alzheimer's disease patients, but most studies did not provide clear evidence on how exercise impacts cognitive function or brain changes associated with the disease.

While the review suggests that there may be potential benefits of physical activity for Alzheimer's patients, it emphasizes the need for more rigorously designed studies to better understand this relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of physical exercise on Alzheimer's disease. A sistematic review]. Agüera Sánchez, MÁ., Barbancho Ma, MÁ., García-Casares, N.[2021]

In young adults, higher daily energy expenditure is associated with better sleep efficiency, but this relationship weakens in older adults, indicating age-related changes in how physical activity affects sleep.

A 12-month exercise training program improved physical fitness in older participants but did not lead to significant changes in sleep efficiency or other sleep characteristics, suggesting that exercise may be more beneficial for those with existing sleep issues rather than for healthy older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of physical fitness and daily energy expenditure on sleep efficiency in young and older humans. Oudegeest-Sander, MH., Eijsvogels, TH., Verheggen, RJ., et al.[2022]

The psychomotor re-education guide (PSEG) significantly improved quality of life and physical fitness in 64 participants with Alzheimer's disease over a 12-month period.

While cognitive abilities declined due to disease progression, the PSEG was effective in enhancing physical capacity and overall well-being in patients with mild to moderate Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Impact of a psychomotor re-education guide on the quality of life of patients with Alzheimer's disease]. Serdà I Ferrer, BC., Ortiz Collado, A., Avila-Castells, P.[2018]

The pilot study involving 37 inactive adults with insomnia showed that zero-time exercise (ZTEx) significantly reduced insomnia severity compared to sleep hygiene education, with a large effect size observed at weeks two, four, and six.

Although the initial benefits of ZTEx diminished by week eight, the training was well-received, with high adherence rates, indicating its potential as a feasible intervention for improving insomnia in inactive adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Zero-time Exercise on inactive adults with insomnia disorder: a pilot randomized controlled trial. Yeung, WF., Lai, AY., Ho, FY., et al.[2019]

A 7-week physical exercise program for 23 elderly patients with Alzheimer's disease led to significant improvements in nutritional status and cognitive function, as measured by the MNA and MMS scales, respectively.

The program also resulted in a reduced risk of falls and fewer behavioral problems, suggesting that physical activity can be a beneficial therapeutic strategy for managing Alzheimer's disease complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility [corrected] of regular physical exercise for patients with moderate to severe Alzheimer disease. Rolland, Y., Rival, L., Pillard, F., et al.[2019]

In a review of 63 articles from AARP magazines, only 3 English articles mentioned that physical activity (PA) could reduce the risk of Alzheimer's disease (AD), while no Spanish articles made this connection.

The study highlights a significant gap in cognitive health information in Spanish-language media, indicating a need for culturally relevant content to better inform diverse populations about the benefits of physical activity in relation to Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are older Latinos told about physical activity and cognition? A content analysis of a top-circulating magazine. Rose, ID., Friedman, DB., Marquez, DX., et al.[2021]

A 12-week resistance training program significantly improved sleep efficiency and reduced sleep fragmentation in older adults, with 62 participants divided into a resistance training group and a control group.

These benefits were also observed in participants with mild cognitive impairment, suggesting that resistance training can be an effective intervention for enhancing sleep quality in older adults, potentially reducing risks associated with Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of resistance training on sleep in Chinese older adults: A randomized controlled trial. Li, Z., Li, J., Yu, G., et al.[2021]

A systematic review of 8 randomized controlled trials involving 562 Alzheimer’s patients found that aerobic physical exercise, whether alone or combined with strength and balance training, can improve physical-functional capacity and cognitive performance in older adults with Alzheimer's disease.

The review also indicated moderate evidence that aerobic exercise can reduce neuropsychiatric symptoms and enhance quality of life for these patients, although results varied across studies and protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Physical Exercise on Alzheimer's disease. A Systematic Review. Cámara-Calmaestra, R., Martínez-Amat, A., Aibar-Almazán, A., et al.[2022]

Exercise therapy may improve sleep architecture in individuals without sleep disorders, potentially due to its effects on body temperature and metabolic function, although the exact mechanisms are not fully understood.

In people with obstructive sleep apnea, supervised exercise therapy can reduce daytime sleepiness, but its impact on overall sleep quality remains unclear, highlighting the need for more rigorous studies to establish effective exercise guidelines for various sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep disorders and exercise: a mini-review. Shah, NM., Bennett, C., Hassan, H., et al.[2023]

In a 12-week randomized controlled trial involving 72 older adults with sleep and cognitive complaints, low-intensity activities like stretching combined with educational content significantly improved self-reported sleep quality more than moderate- or high-intensity activities.

The stretching+educational DVD group saw an average improvement of 5.1 points in sleep quality scores, particularly in reducing nighttime awakenings and the use of sleep medications, highlighting the potential benefits of low-intensity interventions for sleep issues in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exercise and cognitive activity on self-reported sleep quality in community-dwelling older adults with cognitive complaints: a randomized controlled trial. Pa, J., Goodson, W., Bloch, A., et al.[2022]

Citations

1. medrxiv.org medrxiv.org/content/10.1101/2024.12.18.24319240v1.full-text

Evaluation of Dreem headband for sleep staging and EEG ... The DHB 2 uses five dry electrodes: three frontal (Fp2 [ground], F7 and F8) and two occipital (O1 and O2) electrodes to collect the EEG data.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40319389/

Evaluation of Dreem headband for sleep staging and EEG ... We assessed the Dreem headband (DHB) and its automated sleep staging algorithm in 62 older adults [age (mean±SD) 70.5±6.7 years; 12 Alzheimer's].

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352721823002942

Performance of the Dreem 2 EEG headband, relative to ... Core outcomes. Summary statistics showed Dreem Headband overestimated several sleep metrics, including total sleep, efficiency, deep sleep, and rapid eye ...

4. academic.oup.com academic.oup.com/sleep/article-abstract/48/8/zsaf122/8124732

Evaluation of Dreem headband for sleep staging and EEG ... We assessed the Dreem headband (DHB) and its automated sleep staging algorithm in 62 older adults [age (mean ± SD) 70.5 ± 6.7 years; 12 Alzheimer's disease].

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10518099/

Remote evaluation of sleep to enhance understanding of ... Dreem 2 records, stores, and analyses EEG data collected via 5 dry sensors (two frontal sensors at F7 and F8, one ground sensor at Fp2, and two ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38151377/

Performance of the Dreem 2 EEG headband, relative to ... The Dreem Headband performs similarly in Parkinson's disease as it did in non-Parkinson's disease samples and shows promise for improving access to sleep ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10692948/

Acoustic stimulation as a promising technique to enhance ... (A) We used the DREEM 2 headband device (DH) to record sleep data and to stimulate the slow-wave activity by closed-loop acoustic stimulation. The DH was worn ...

8. researchgate.net researchgate.net/publication/387281763_Evaluation_of_Dreem_headband_for_sleep_staging_and_EEG_spectral_analysis_in_people_living_with_Alzheimers_and_older_adults

Evaluation of Dreem headband for sleep staging and EEG ... Methods: We assessed the Dreem headband (DHB), and its automated sleep staging algorithm in 62 older adults [Age (mean±SD) 70.5±6.7 years; 12 ...