Sleep Well for Healthy Brain

Poor Quality Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04583033
• Other study ID #: 20201031
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Poor Quality Sleep

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