Sleep Well for Healthy Brain

University of Miami

Status: Completed

Conditions: Poor Quality Sleep

Treatments: Behavioral: Cognitive Behavioral Therapy (CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04583033

20201031

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: Female

Ages: 55 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Cognitive Behavioral Therapy (CBT) Group

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)

Control Group

No Intervention group

Description:

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