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OpenTrials
Completed

NCT Number: NCT04583033

Sleep Well for Healthy Brain

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

Completed

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Key information

Conditions

Poor Quality Sleep

Age range

55 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

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.

Primary outcomes

  1. Rate of brain tissue volume loss in specific brain regions

    Time frame: Year 2

    As evaluated from the Magnetic Resonance Imaging (MRI) Brain scan

Secondary outcomes

  1. Cognitive Performance

    Time frame: Year 2

    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%.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Florida Department of Health

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 12, 2020
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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