A Dyadic Approach for Managing Sleep Disturbances in Alzheimer’s Disease using Cognitive Behavioral Therapy for Insomnia

Updated on 26 January 2022
cognitive impairment
Accepts healthy volunteers


This study is looking for people who have Alzheimer’s, and their family caregivers. The study is testing whether cognitive behavioral therapy can improve sleep.


Study schedule:
At the start of the study:
-You will answer questionnaires about sleep, depression, quality of life and cognition.
-You will use a sleep diary to record your sleep habits.
-You will wear a small activity monitor (wristwatch style or similar) to track your quality of sleep.
During the study:
-You will have cognitive behavioral therapy sessions. There will be one session per week, for four weeks. Each session is one hour.
-You will repeat the study-start activities.
The study will end after about 2 months.

Study activities may include:
-Completing questionnaires about sleep, depression, quality of life and cognition.
-Completing sleep diaries.
-Wearing an activity monitor to track your sleep.
-Having cognitive behavioral therapy sessions.

Treatment or experiment details:
-Cognitive behavioral therapy is a form of psychotherapy treatment. In this study, it is intended to help with sleep problems.
-You and your study partner will participate in all sessions together, including the cognitive behavioral therapy.

Additional details:
-All study visits will be at your home.

Condition *Healthy Volunteers, Dementia, Alzheimer's Disease
Clinical Study IdentifierTX249136
Last Modified on26 January 2022


Yes No Not Sure

Inclusion Criteria

You could be eligible for this study if
You can read and speak English
You live at home
You have mild Alzheimer’s or a related dementia, as confirmed by study-start testing
You have sleep problems
Your dosage of medications for dementia, mood, pain, or sleep (if you take any), has been stable for the past 90 days
You have a ‘study partner’—a family member, friend, spouse, or caregiver—who helps you every day and would be willing to answer questions about you
You may not be eligible for this study if
You have a significant impairment of your eyesight or hearing, even with glasses or hearing aids
You plan to move to a nursing home or similar facility within the next six months
Your study partner has cognitive impairment, uses sleeping medications, or has a serious medical or psychiatric condition
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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