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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04583033
Other study ID # 20201031
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 28, 2021
Est. completion date October 31, 2023

Study information

Verified date November 2023
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 55 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive 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.

Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami Florida Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of brain tissue volume loss in specific brain regions As evaluated from the Magnetic Resonance Imaging (MRI) Brain scan Year 2
Secondary Cognitive Performance Cognitive 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%. Year 2
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