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Search / Trial NCT05565833

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

Launched by UNIVERSITY OF VIRGINIA · Sep 29, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Insomnia Alzheimer's Disease Mild Cognitive Impairment Cognitive Behavioral Therapy

ClinConnect Summary

The SHUTi MIND trial is studying how an online therapy program can help older adults with insomnia and mild cognitive impairment. This program, called cognitive behavioral therapy for insomnia (CBT-I), aims to improve sleep quality and cognitive health. Participants in the study will be randomly assigned to either receive the CBT-I intervention or participate in a patient education program. Researchers want to see how these approaches affect sleep patterns, daytime functioning, and cognitive abilities.

To join the study, individuals must be at least 65 years old, live in the U.S., and be able to read and speak English. They should have access to the internet and experience significant sleep difficulties that impact their daily life. Participants will need to provide consent and be available for the duration of the study. It's important to note that individuals currently receiving treatment for insomnia or with certain medical conditions are not eligible to participate. Those who join can expect to engage with the program online, helping researchers understand the benefits of internet-based therapy for sleep and cognitive health.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 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

About University Of Virginia

The University of Virginia (UVA) is a prestigious academic institution renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a focus on interdisciplinary collaboration, UVA leverages its extensive resources and expertise in various fields, including medicine, engineering, and public health, to drive cutting-edge studies that address pressing health challenges. The university's clinical trial programs aim to translate scientific discoveries into effective treatments, ensuring the highest standards of ethical practice and participant safety. Through its strong emphasis on community engagement and education, UVA fosters a culture of research that not only contributes to the scientific community but also enhances the well-being of the populations it serves.

Locations

Charlottesville, Virginia, United States

Patients applied

0 patients applied

Trial Officials

Meghan K Mattos, PhD, RN, CNL

Principal Investigator

University of Virginia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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