Combating Alzheimer's Through Sleep and Exercise

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT04855630
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Mar 1, 2023
Status verified
Apr 2026
Primary completion
Dec 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Total Cholesterol Levels [ Time Frame: Up to Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami HospitalsMiamiFlorida33136
Debbie Chung, PhD
3052431301
Azizi A Seixas, PhD
3052431301
Azizi A Seixas, PhD (PRINCIPAL_INVESTIGATOR)
Debbie Chung, PhD (SUB_INVESTIGATOR)
Alberto Ramos, MD (SUB_INVESTIGATOR)

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