Recruiting NCT04855630
Combating Alzheimer's Through Sleep and Exercise
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DREEM 2 Headband, Exercise Routine.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Dementia. Basic parameters: 45 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Combating Alzheimer's Through Sleep and Exercise (CASE)
Overview
The purpose of this research is to see how sleep and exercise affects dementia risk over time.
Interventions
- Device DREEM 2 Headband
Participants will wear the DREEM 2 headband for 3 months for a minimum of 4 out of 7 nights per week and will participate in its digital therapeutic Cognitive Behavioral Therapy - Insomnia (CBT-I) intervention (entails brain stimulation to improve slow wave sleep and sleep hygiene counseling tips to improve sleep behaviors). - Other Exercise Routine
Participants will partake in a guided exercise routine. Each routine consists of 30-minute mild circuit training session twice per week for 3 months.
Primary outcome measures
- Total Cholesterol Levels [Time frame: Up to Week 12]
- High-Density Lipoprotein (HDL) Levels [Time frame: Up to Week 12]
- Low-Density Lipoprotein (LDL) Levels [Time frame: Up to Week 12]
- Triglycerides Levels [Time frame: Up to Week 12]
- High-sensitivity C-reactive protein (hs-CRP) Levels [Time frame: Up to Week 12]
- HbA1c Levels [Time frame: Up to Week 12]
- Heart Rate [Time frame: Up to Week 12]
- Blood Pressure [Time frame: Up to Week 12]
- Total Sleep Duration [Time frame: Up to Week 12]
- Slow Wave Sleep Duration [Time frame: Up to Week 12]
Eligibility criteria
Inclusion criteria
- Able to perform mild exercise
- Able to wear DREEM 2 Headband
- Able to wear a Fitbit wrist watch
- Able to perform the Everlywell biomarker procedure
- Able to Understand and Speak English
- Able to operate a digital device like mobile phone, iPad, or computer
- Self-reported history of problems with cognitive impairment: memory, concentration, and processing information
- Only participants cognitively able and willing to provide consent will be included.
Exclusion criteria
- Prohibited from or unable to perform mild exercise
- Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason
- Unable to speak or understand English
- Unable to use mobile device/smartphone technology
- Unable or unwilling to consent for any reason.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Miami Hospitals — Miami
Publications
- Chung D, Larsen BA, Garchitorena Gomez LG, Ramos AR, Kirk-Sanchez NJ, Jean-Louis G, Seixas AA. Combating Alzheimer's through sleep and exercise (CASE): A study protocol. Geroscience. 2026 Jun 6. doi: 10.1007/s11357-026-02337-1. Online ahead of print. PMID 42249253
Identifiers
NCT: NCT04855630 · 20220931 · 20-01023