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NCT Number: NCT04855630

Combating Alzheimer's Through Sleep and Exercise

The purpose of this research is to see how sleep and exercise affects dementia risk over time.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Hospitals

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Alberto Ramos, MD

SUB_INVESTIGATOR

Azizi A Seixas, PhD

CONTACT

[email protected]

3052431301

Azizi A Seixas, PhD

PRINCIPAL_INVESTIGATOR

Debbie Chung, PhD

CONTACT

[email protected]

3052431301

Debbie Chung, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DREEM 2 Headband

Device

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).

Exercise Routine

Other

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 outcomes

  1. Total Cholesterol Levels

    Time frame: Up to Week 12

    Measured from blood sample

  2. High-Density Lipoprotein (HDL) Levels

    Time frame: Up to Week 12

    Measured from blood sample

  3. Low-Density Lipoprotein (LDL) Levels

    Time frame: Up to Week 12

    Measured from blood sample

  4. Triglycerides Levels

    Time frame: Up to Week 12

    Measured from blood sample

  5. High-sensitivity C-reactive protein (hs-CRP) Levels

    Time frame: Up to Week 12

    Measured from blood sample

  6. HbA1c Levels

    Time frame: Up to Week 12

    Measured from blood sample

  7. Heart Rate

    Time frame: Up to Week 12

    Measured from Fitbit

  8. Blood Pressure

    Time frame: Up to Week 12

    Measured from Fitbit

  9. Total Sleep Duration

    Time frame: Up to Week 12

    Measured from DREEM 2

  10. Slow Wave Sleep Duration

    Time frame: Up to Week 12

    Measured from DREEM 2

  11. Cortisol Levels

    Time frame: Up to Week 12

    Measured from Urine Sample

  12. Cortisone Levels

    Time frame: Up to Week 12

    Measured from Urine Sample

  13. Melatonin Levels

    Time frame: Up to Week 12

    Measured from Urine Sample

  14. Creatinine Levels

    Time frame: Up to Week 12

    Measured from Urine Sample

Study contacts

Contact information is provided by the study sponsor or research team.

Azizi A Seixas, PhD

CONTACT

[email protected]

3052431301

Debbie Chung, PhD

CONTACT

[email protected]

3052431301

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Dreem
  • Shipley Foundation

Registry information

Official study title

Combating Alzheimer's Through Sleep and Exercise (CASE)

Acronym: CASE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 22, 2021
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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