Recruiting

Sleep & Exercise

Sponsor:

University of Miami

Code:

NCT04855630

Conditions

Alzheimer Disease

Dementia

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

DREEM 2 Headband

Exercise Routine

Study Details

Brief summary:

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

Conditions

Alzheimer Disease

Dementia

Study ID

NCT04855630

Start date

Mar 1, 2023

Status verified date

Apr, 2026

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Dec 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Able to perform mild exercise
2. Able to wear DREEM 2 Headband
3. Able to wear a Fitbit wrist watch
4. Able to perform the Everlywell biomarker procedure
5. Able to Understand and Speak English
6. Able to operate a digital device like mobile phone, iPad, or computer
7. Self-reported history of problems with cognitive impairment: memory, concentration, and processing information
8. Only participants cognitively able and willing to provide consent will be included.

Exclusion Criteria:

1. Prohibited from or unable to perform mild exercise
2. Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason
3. Unable to speak or understand English
4. Unable to use mobile device/smartphone technology
5. Unable or unwilling to consent for any reason.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Sleep Only Group

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

active comparator: Exercise Only Group

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

active comparator: Exercise and Sleep Group

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

Interventions

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).

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 measure

  • 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 ]
  • Cortisol Levels [ Time Frame: Up to Week 12 ]
  • Cortisone Levels [ Time Frame: Up to Week 12 ]
  • Melatonin Levels [ Time Frame: Up to Week 12 ]
  • Creatinine Levels [ Time Frame: Up to Week 12 ]

Central Contacts and Locations

Central contacts

Azizi A Seixas, PhD

3052431301Azizi.seixas@med.miami.edu

Debbie Chung, PhD

3052431301dxc1729@miami.edu

Locations

University of Miami Hospitals

Recruiting

Miami, Florida, United States, 33136

Contacts

Debbie Chung, PhD

3052431301dxc1729@miami.edu

Azizi A Seixas, PhD

3052431301Azizi.seixas@med.miami.edu

Principal Investigator:

Azizi A Seixas, PhD

More Information

Sponsor

University of Miami

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-04-20.