CASE: Combating Alzheimer's Through Sleep and Exercise

Sponsor
University of Miami (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04855630
Collaborator
(none)
30
1
3
29
1

Study Details

Study Description

Brief Summary

Alzheimer's/dementia is an increasingly critical public health risk, with over 50 million Americans at risk for the disease. To stem the burden of Alzheimer's disease, prophylactic and protective strategies such as physical activity and sleep have been recommended to reduce the risk of cognitive decline and Alzheimer's/dementia. Previous research indicate that exercise improves cognition and lowers dementia risk and may be a promising intervention to address dementia risk in the general population. Sleep, specifically slow wave sleep, may reduce dementia risk, based on previous work showing that greater levels of slow wave sleep was related to higher cognition. However, little is known about the independent and combined effects exercise and sleep have on cognition. The proposed study therefore aims to investigate the independent and combined effects exercise (aerobic and stretching) and sleep have on cognition and what heart health, sleep and stress correlates confound this association.

Condition or Disease Intervention/Treatment Phase
  • Other: DREEM 2 Headband
  • Other: Fitbit
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Combating Alzheimer's Through Sleep and Exercise (CASE)
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sleep Only

Other: 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 CBT-I intervention (entails brain stimulation to improve slow wave sleep and sleep hygiene counseling tips to improve sleep behaviors).

Active Comparator: Exercise Only

Other: Fitbit
Participants will partake in a guided exercise routine (30-minute mild circuit training session while VO2 is estimated from a Fitbit device twice per week for 3 months).

Active Comparator: Exercise + Sleep

Other: 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 CBT-I intervention (entails brain stimulation to improve slow wave sleep and sleep hygiene counseling tips to improve sleep behaviors).

Other: Fitbit
Participants will partake in a guided exercise routine (30-minute mild circuit training session while VO2 is estimated from a Fitbit device twice per week for 3 months).

Outcome Measures

Primary Outcome Measures

  1. Total Cholesterol Level [Week 6]

    Measured from blood sample

  2. Total Cholesterol Level [Week 12]

    Measured from blood sample

  3. High-Density Lipoprotein (HDL) Level [Week 6]

    Measured from blood sample

  4. High-Density Lipoprotein (HDL) Level [Week 12]

    Measured from blood sample

  5. Calculated Low-Density Lipoprotein (LDL) Level [Week 6]

    Measured from blood sample

  6. Calculated Low-Density Lipoprotein (LDL) Level [Week 12]

    Measured from blood sample

  7. Triglycerides Level [Week 6]

    Measured from blood sample

  8. Triglycerides Level [Week 12]

    Measured from blood sample

  9. high-sensitivity C-reactive protein (hs-CRP) Level [Week 6]

    Measured from blood sample

  10. high-sensitivity C-reactive protein (hs-CRP) Level [Week 12]

    Measured from blood sample

  11. HbA1c [Week 6]

    Measured from blood sample

  12. HbA1c [Week 12]

    Measured from blood sample

  13. Heart Rate [Week 6]

    Measured from Fitbit

  14. Heart Rate [Week 12]

    Measured from Fitbit

  15. Blood Pressure [Week 6]

    Measured from Fitbit

  16. Blood Pressure [Week 12]

    Measured from Fitbit

  17. Total Sleep Duration [Week 6]

    Measured from DREEM 2

  18. Total Sleep Duration [Week 12]

    Measured from DREEM 2

  19. Slow Wave Sleep Duration [Week 6]

    Measured from DREEM 2

  20. Slow Wave Sleep Duration [Week 12]

    Measured from DREEM 2

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age 45 years and older

  2. Able to perform mild exercise

  3. Able to wear DREEM 2 Headband

  4. Able to wear a Fitbit wrist watch

  5. Able to perform the Everlywell biomarker procedure

  6. Able to Understand and Speak English

  7. Able to operate a digital device like mobile phone, iPad, or computer

  8. Self-reported history of problems with cognitive impairment: memory, concentration, and processing information

  9. Only participants cognitively able and willing to provide consent will be included.

Exclusion Criteria:
  1. Under 45 years old

  2. Prohibited from or unable to perform mild exercise

  3. Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason

  4. Unable to speak or understand English

  5. Unable to use mobile device/smartphone technology

  6. Unable or unwilling to consent for any reason.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • University of Miami

Investigators

  • Principal Investigator: Azizi A Seixas, PhD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Azizi Seixas, Associate Professor, University of Miami
ClinicalTrials.gov Identifier:
NCT04855630
Other Study ID Numbers:
  • 20-01023
First Posted:
Apr 22, 2021
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 21, 2022