Sleep Well for Healthy Brain

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

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

Study Overview

• Status: Completed
• Conditions: Poor Quality Sleep
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (CBT)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clara I. Morales; Phone Number: 305-243-3404; Email: c.morales1@miami.edu
• Study Contact Backup: Name: Sang Lee; Phone Number: 305-243-6559; Email: lsang2@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral Therapy (CBT) Group; Participants will receive CBT intervention bi-weekly for total of six (6) sessions.	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.
No Intervention: Control Group; Participants will not receive any intervention as part of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of brain tissue volume loss in specific brain regions	As evaluated from the Magnetic Resonance Imaging (MRI) Brain scan	Year 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Florida Department of Health
• Investigators: Principal Investigator: Noam Alperin, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20201031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No