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

Last updated: June 14, 2023
Sponsor: University of Virginia
Overall Status: Active - Recruiting

Phase

2

Condition

Mild Cognitive Impairment

Alzheimer's Disease

Dementia

Treatment

patient education

SHUTi OASIS

Clinical Study ID

NCT05565833
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 144
Treatment Group(s): 2
Primary Treatment: patient education
Phase: 2
Study Start date:
February 27, 2023
Estimated Completion Date:
January 20, 2028

Study 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

Connect with a study center

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

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