30 Participants Needed

Sleep and Exercise for Alzheimer's Disease

(CASE Trial)

Recruiting at 1 trial location
JM
AA
DC
Overseen ByDebbie Chung, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is studying whether better sleep and more exercise can reduce the risk of dementia in people who are at risk. The idea is that these lifestyle changes might help keep the brain healthy.

Will I have to stop taking my current medications?

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

Is it safe for humans to use exercise and devices like the Dreem 2 Headband and Fitbit for Alzheimer's disease?

Exercise is generally safe for people with Alzheimer's disease and can improve daily life activities, mental health, and physical fitness. However, specific safety data for devices like the Dreem 2 Headband and Fitbit in this context is not provided in the available research.12345

How does the exercise routine treatment for Alzheimer's differ from other treatments?

The exercise routine treatment for Alzheimer's is unique because it focuses on improving sleep quality and cognitive function through physical activity, rather than using medication. This approach leverages the benefits of exercise on sleep efficiency and overall health, which may help reduce the risk of Alzheimer's disease.678910

What data supports the effectiveness of the treatment for Alzheimer's disease?

Research shows that exercise can help improve daily life activities, mental health, and some cognitive functions in people with Alzheimer's disease. Exercise programs have been found to enhance physical fitness and may positively impact symptoms related to Alzheimer's.211121314

Who Is on the Research Team?

AA

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.
See 4 more

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
See 2 more

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?
3Treatment groups
Experimental Treatment
Active Control
Group I: Sleep Only GroupExperimental Treatment1 Intervention
Participants in this group will wear the DREEM 2 headband for 12 weeks.
Group II: Exercise Only GroupActive Control1 Intervention
Participants in this group will workout twice a week for 12 weeks.
Group III: Exercise and Sleep GroupActive Control2 Interventions
Participants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks.

Find a Clinic Near You

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

Citations

What are the Benefits of Exercise for Alzheimer's Disease? A Systematic Review of the Past 10 Years. [2018]
Evaluation of a home-based exercise program in the treatment of Alzheimer's disease: the Maximizing Independence in Dementia (MIND) study. [2022]
Benefits of physical exercise for older adults with Alzheimer's disease. [2008]
[Effect of physical exercise on Alzheimer's disease. A sistematic review]. [2021]
Effectiveness of Physical Exercise on Alzheimer's disease. A Systematic Review. [2022]
Feasibility [corrected] of regular physical exercise for patients with moderate to severe Alzheimer disease. [2019]
[Impact of a psychomotor re-education guide on the quality of life of patients with Alzheimer's disease]. [2018]
What are older Latinos told about physical activity and cognition? A content analysis of a top-circulating magazine. [2021]
Effect of a multimodal exercise program on sleep disturbances and instrumental activities of daily living performance on Parkinson's and Alzheimer's disease patients. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
The effect of resistance training on sleep in Chinese older adults: A randomized controlled trial. [2021]
Sleep disorders and exercise: a mini-review. [2023]
12.United Statespubmed.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. [2022]
Effects of Zero-time Exercise on inactive adults with insomnia disorder: a pilot randomized controlled trial. [2019]
Impact of physical fitness and daily energy expenditure on sleep efficiency in young and older humans. [2022]
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