NCT04583033

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

September 28, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

October 6, 2020

Last Update Submit

November 29, 2023

Conditions

Poor Quality Sleep

Outcome Measures

Primary Outcomes (1)

  • Rate of brain tissue volume loss in specific brain regions

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

    Year 2

Secondary Outcomes (1)

  • Cognitive Performance

    Year 2

Study Arms (2)

Cognitive Behavioral Therapy (CBT) Group

EXPERIMENTAL

Participants will receive CBT intervention bi-weekly for total of six (6) sessions.

Behavioral: Cognitive Behavioral Therapy (CBT)

Control Group

NO INTERVENTION

Participants will not receive any intervention as part of the study.

Interventions

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.

Cognitive Behavioral Therapy (CBT) Group

Eligibility Criteria

Age55 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Noam Alperin

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 12, 2020

Study Start

September 28, 2021

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)