NCT04855630

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
32mo left

Started Mar 2023

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Mar 2023Dec 2028

First Submitted

Initial submission to the registry

April 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

5.8 years

First QC Date

April 19, 2021

Last Update Submit

April 14, 2026

Conditions

Alzheimer DiseaseDementia

Outcome Measures

Primary Outcomes (14)

  • Total Cholesterol Levels

    Measured from blood sample

    Up to Week 12

  • High-Density Lipoprotein (HDL) Levels

    Measured from blood sample

    Up to Week 12

  • Low-Density Lipoprotein (LDL) Levels

    Measured from blood sample

    Up to Week 12

  • Triglycerides Levels

    Measured from blood sample

    Up to Week 12

  • High-sensitivity C-reactive protein (hs-CRP) Levels

    Measured from blood sample

    Up to Week 12

  • HbA1c Levels

    Measured from blood sample

    Up to Week 12

  • Heart Rate

    Measured from Fitbit

    Up to Week 12

  • Blood Pressure

    Measured from Fitbit

    Up to Week 12

  • Total Sleep Duration

    Measured from DREEM 2

    Up to Week 12

  • Slow Wave Sleep Duration

    Measured from DREEM 2

    Up to Week 12

  • Cortisol Levels

    Measured from Urine Sample

    Up to Week 12

  • Cortisone Levels

    Measured from Urine Sample

    Up to Week 12

  • Melatonin Levels

    Measured from Urine Sample

    Up to Week 12

  • Creatinine Levels

    Measured from Urine Sample

    Up to Week 12

Study Arms (3)

Sleep Only Group

EXPERIMENTAL

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

Device: DREEM 2 Headband

Exercise Only Group

ACTIVE COMPARATOR

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

Other: Exercise Routine

Exercise and Sleep Group

ACTIVE COMPARATOR

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

Device: DREEM 2 HeadbandOther: Exercise Routine

Interventions

DREEM 2 HeadbandDEVICE

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 and Sleep GroupSleep Only Group
Exercise RoutineOTHER

Participants will partake in a guided exercise routine. Each routine consists of 30-minute mild circuit training session twice per week for 3 months.

Exercise Only GroupExercise and Sleep Group

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Hospitals

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Azizi A Seixas, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Azizi A Seixas, PhD

CONTACT

3052431301Azizi.seixas@med.miami.edu

Debbie Chung, PhD

CONTACT

3052431301dxc1729@miami.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 22, 2021

Study Start

March 1, 2023

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)