DREEM 2 Headband for Dementia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NYU Langone Health, New York, NY
Dementia+1 More
DREEM 2 Headband - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether exercise and sleep may help improve cognition for individuals with Alzheimer's disease.

See full description

Eligible Conditions

  • Dementia
  • Alzheimer Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether DREEM 2 Headband will improve 10 primary outcomes in patients with Dementia. Measurement will happen over the course of Week 12.

Week 12
Blood Pressure
Calculated Low-Density Lipoprotein (LDL) Level
HbA1c
Heart Rate
High-Density Lipoprotein (HDL) Level
Slow Wave Sleep Duration
Total Cholesterol Level
Total Sleep Duration
Triglycerides Level
high-sensitivity C-reactive protein (hs-CRP) Level

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Exercise Only
1 of 3
Exercise + Sleep
1 of 3
Sleep Only
1 of 3
Active Control
Experimental Treatment

This trial requires 30 total participants across 3 different treatment groups

This trial involves 3 different treatments. DREEM 2 Headband is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Sleep Only
Other
Exercise Only
Other
Exercise + Sleep

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 12 for reporting.

Who is running the study

Principal Investigator
A. S.
Prof. Azizi Seixas, Associate Professor
University of Miami

Closest Location

NYU Langone Health - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Can use a digital device, such as a mobile phone, iPad, or computer. show original
The survey found that a significant number of respondents reported having cognitive impairment issues in the past, such as memory problems, difficulty concentrating, and impaired information processing. show original
People who are 45 years or older are more likely to have a stroke. show original
The text suggests that the person is able to do mild exercise. show original
You will be able to wear the DREEM 2 Headband comfortably to help you sleep better. show original
I am able to wear a Fitbit wrist watch. show original
in your own home The Everlywell biomarker procedure can be done at home. show original
This text is about someone who is able to understand and speak English. show original
Only people who are able to and want to provide consent will be included. show original

Patient Q&A Section

How many people get alzheimer disease a year in the United States?

"Age and gender influence the risk for AD. Approximately 80% of patients have Alzheimer's at onset, with about one-third presenting with mild cognitive impairment, and half having mild dementia; the prevalence of Alzheimer's disease increases rapidly with age and the disease continues to expand." - Anonymous Online Contributor

Unverified Answer

What are common treatments for alzheimer disease?

"Pharmacotherapy is the treatment of choice for most patients presenting with early onset AD. The most common medications used to treat patients with moderate-to-late onset AD vary with country. The most common medications used are antidepressants to treat depressive symptoms and sedatives for insomnia. Anticholinergics may also be used. Patients with very late onset AD commonly receive neuroleptic medications in order to control agitation, hallucinations or other behavioral disturbances. Older patients frequently present with severe cognitive deficits and are not likely to respond to medication. The optimal treatment strategy for patients with Alzheimer disease is not well understood, and many different medications can be used. However, several recent studies indicate some medications may be superior to others in the management of patients with AD." - Anonymous Online Contributor

Unverified Answer

What is alzheimer disease?

"Alzheimer's disease (AD) is a progressive neurodegenerative disorder. It is characterized by abnormal accumulations of beta-amyloid (Aβ) in the brain and brain tissue, tau protein tangles, neurofibrillary tangles and senile plaques. The exact cause is unknown but is believed to disrupt signaling between neurons, thereby causing the death of nerve cells in memory areas. It is the sixth-leading cause of death in the United States and other developed nations." - Anonymous Online Contributor

Unverified Answer

What are the signs of alzheimer disease?

"If someone has any of these symptoms it is important to find out what causes them as this is very important and helps treatment of the disease. Cognitive impairment is the most important criterion of alzheimers. Early and constant [dementia](https://www.withpower.com/clinical-trials/dementia) is a feature of most forms of Alzheimers. In an onset-of-dementia with age-changes setting of Alzheimer`s, the diagnosis of frontotemporal dementias may be appropriate with memory loss, language changes and behaviour that change with age and are progressive. If there are atypical features of progressive dementia of the Alzheimer's type, a diagnosis of the dementia with Lewy bodies variant is more appropriate so that treatment with Lewy bodies can be monitored appropriately." - Anonymous Online Contributor

Unverified Answer

What causes alzheimer disease?

"We hypothesize that an abnormal amyloidogenic precursor protein (APP) may trigger the disease and this is amplified in the presence of a genetic risk factor, such as APOE4." - Anonymous Online Contributor

Unverified Answer

Can alzheimer disease be cured?

"At present no treatments exist that improve or terminate the course of Alzheimer's disease, although this is one of the best researched and most severe debilitating diseases. The aim of this paper is to present a rationale for a cure based on the understanding of the pathological and biochemical cascade that promotes the pathological manifestations of Alzheimer's disease." - Anonymous Online Contributor

Unverified Answer

Is dreem 2 headband typically used in combination with any other treatments?

"The most common use of dreem 2 in combination was with cholinergic agents and the most common use of dreem 2 by itself was with aniridia. A greater number of the subjects were also prescribed cholinergic agents. A significant number of AAS users reported that dreem 2 is the only treatment type used in a majority of their use of AAS. This information may have an impact on the marketing of dreem 2, providing potential avenues to market additional products for use with AAS." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating alzheimer disease?

"Very few new drug treatments for AD have been reported in recent years. The development of new treatments will depend on improved understanding of the biology of AD and identification of new targets for therapeutic intervention." - Anonymous Online Contributor

Unverified Answer

What does dreem 2 headband usually treat?

"This case series demonstrates effectiveness of the use of a skull cap, when worn by a patient suffering from dementia, as an add-on to other therapeutic measures. A skull cap can be a simple, inexpensive or even free intervention, when patients are not satisfied with the management of their dementia with existing pharmacological treatments. The skull cap has been used in our institution for over a decade, and we are quite satisfied with our results, which are being disseminated in our community." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of alzheimer disease?

"A study from 2017 found that dementia could not be explained solely by cognitive changes. According to other studies, cognitive changes are observed in those with high risk for Alzheimer Disease before dementia begins, but other risk factors contribute to cognitive decline in those with no risk of dementia or mild cognitive impairment (mild cognitive deficits) before dementia begins. The authors propose that these two groups may have different brain processes that can impact cognition in different ways. You can find the most recent dementia clinical trials by using [Power](https://www.power." - Anonymous Online Contributor

Unverified Answer

Has dreem 2 headband proven to be more effective than a placebo?

"There have been many anecdotal claims about the headband, many unsupported and unsubstantiated by convincing empirical evidence. Although the headband may appear to be effective, the results on most reported trials are inconclusive and have low quality. This review demonstrates that there is no compelling evidence to support the effectiveness of the headband against the challenges associated with Alzheimer's disease." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets alzheimer disease?

"Altered brain development is present well before neurodegeneration is evident on imaging. Identifying the prevalence of early brain changes may lead to earlier detection of early-stage cases of AD. The data support further study of early brain changes in a population-based sample of young Americans as a means of screening for disease at-risk and as a target population for early intervention." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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