Combating Alzheimer's Through Sleep and Exercise

NCT04855630 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-20

No results posted yet for this study

Summary

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

Conditions

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.

Sponsors & Collaborators

  • Shipley Foundation

    collaborator UNKNOWN
  • Dreem

    collaborator INDUSTRY
  • University of Miami

    lead OTHER

Principal Investigators

  • Azizi A Seixas, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2028-12-30
Completion
2028-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04855630 on ClinicalTrials.gov