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Sleep Well for Healthy Brain

Lifestyle Stressors of Hippocampus and Alzheimer's Disease (AD) Related Brain Regions: Potential for Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04583033
Enrollment
100
Registered
2020-10-12
Start date
2021-09-28
Completion date
2023-10-31
Last updated
2023-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor Quality Sleep

Brief summary

The purpose of this study is to slow down the aging of the participant's brain by improving sleep quality.

Interventions

BEHAVIORALCognitive Behavioral Therapy (CBT)

Treatment components include stimulus control, sleep restriction therapy, relaxation, and cognitive therapy. Each session will last approximately one hour and will be provided on line.

Sponsors

Florida Department of Health
CollaboratorOTHER_GOV
University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
55 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* English-speaking healthy subjects age 55 years and older capable and willing to consent to participate in the study. In addition, subject should be cognitively normal and have well documented sleep issues that results with poor sleep quality based on self-reported assessment.

Exclusion criteria

* pregnant women * cognitively impaired subjects not able to provide consent * prisoners * Subjects 55 years of age and older that meet criteria for mild cognitive impairment. * Subjects with any neurological disorder. * Any other condition that in the opinion of the investigator may affect the participation in this study

Design outcomes

Primary

MeasureTime frameDescription
Rate of brain tissue volume loss in specific brain regionsYear 2As evaluated from the Magnetic Resonance Imaging (MRI) Brain scan

Secondary

MeasureTime frameDescription
Cognitive PerformanceYear 2Cognitive performance will be assessed using a Memory test which has a composite score ranging from 80 to 120 % with a higher score indicating better performance and a midrange at 100%.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026