Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)

  • STATUS
    Recruiting
  • End date
    Jan 20, 2028
  • participants needed
    144
  • sponsor
    University of Virginia
Updated on 14 June 2023
Online studies

Summary

This randomized controlled trial will evaluate the impact of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep and the extent to which it contributes to cognitive health in individuals with mild cognitive impairment. Participants with insomnia who meet the study criteria for mild cognitive impairment will be recruited to determine the effects of the CBT-I intervention compared to a patient education condition on sleep and cognition. Internet-based recruitment methods will be used, and outcomes include sleep variables, daytime variables, and cognitive status.

Description

The SHUTi MIND study is an NIH-funded study at the University of Virginia and will test an online interactive program called Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness (SHUTi OASIS) on adults aged 65 and older who struggle with sleep and cognitive concerns for a 2-year period. The help offered by SHUTi OASIS program is based on interventions for insomnia developed over the past 20 years and tested in numerous scientific studies. Typically, this type of training is only available from psychologists and physicians specially trained in behavioral sleep medicine and only offered in weekly face-to-face sessions. SHUTi OASIS was created to make this kind of help available to more people through a convenient home-based program that can be accessed anytime via the Internet. Study participation will take about 2 years with the majority of study hours occurring in the first three months. After a telephone screening, participants will complete a pre-assessment consisting of an online cognitive test, online questionnaire, and sleep diaries. After completing the pre-assessment, participants will be randomly assigned to either the experimental website or a control website. Participation will take a maximum of 2 hours per week for a nine-week period. After that, participants will complete follow-up assessments at 9 weeks, 6 months, 12 months, 18 months, and 2 years to see how their participation has influenced their sleeping and cognitive functioning. Participants will be compensated for their time with up to $300 in gift cards for study completion. On the study website: www.shutimind.org, you will find more information about the study, our team, and a link to apply there. Interested candidates should submit an interest form which the study team will review. If you are eligible for the study, a study team member will contact you to schedule a time to review the study consent form and conduct an additional eligibility screen. Please reach out to us with any questions, and thank you for your time and consideration: SHUTiMIND@uvahealth.org

Details
Condition Dementia, Mild Cognitive Impairment, Alzheimer's Disease
Treatment patient education, SHUTi OASIS
Clinical Study IdentifierNCT05565833
SponsorUniversity of Virginia
Last Modified on14 June 2023

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, aged ≥ 65 years of age
Cognitive impairment through study assessment
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Able to speak and read English, and is a US resident
Have access to any Internet-enabled device (computer, tablet, smartphone) and willing to be emailed about the study
Sleep-onset insomnia and/or sleep maintenance insomnia symptoms
The sleep disturbance (or associated daytime fatigue) causes significant distress or impairment in social, occupational, or other areas of functioning over the past three months
Stable medication regimen unless medication is known to cause insomnia

Exclusion Criteria

Current psychological treatment for insomnia
Initiation of psychological or psychiatric treatment within the past three months
Current diagnosis of Huntington's or Parkinson's disease
Current treatment for hyperthyroidism
Currently undergoing chemotherapy
Presence of asthma or respiratory concerns with night treatment
Chronic pain treated with opioids
Not recovered from a brain tumor, injury, or infection
Epilepsy without stable treatment for at least 3 months
Irregular sleep schedule
Use of stimulating medications after 5pm or taken for less than 3 months
Psychotic or bipolar disorder
Moderate to high risk of suicide
Alcohol or drug abuse within the past year
Other untreated sleep disorders (e.g., obstructive sleep apnea)
Study screen for severe depression
Clear my responses

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.

You are contacting

Investigator Avatar

Primary Contact

site

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

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note