Skip to content
TrialMatch
Sign up
Recruiting Phase 2

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

Create a profile to match View the full record on ClinicalTrials.gov

About this study

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.

Condition
Insomnia, Cognitive Dysfunction, Mild Cognitive Impairment, Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders, Nervous System Diseases, Alzheimer Disease
Tested
SHUTi OASIS, Patient Education
Sponsor
University of Virginia

Who can join

Age
65 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 11

  • Minimum age: 65 years
  • Study condition: Insomnia, Cognitive Dysfunction, Mild Cognitive Impairment, Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders, Nervous System Diseases, Alzheimer Disease
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged ≥ 65 years of age.
  • 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.
  • Cognitive impairment through study assessment.
  • Stable medication regimen unless medication is known to cause insomnia

Exclusion 16

  • 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

Where

1 site, 1 recruiting

University of Virginia

Charlottesville, Virginia, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.