NCT05565833 · Phase 2 · RECRUITING

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

This trial tests whether an internet-delivered program of cognitive behavioral therapy for insomnia (called SHUTi) improves sleep and thinking skills in adults 65 and older with insomnia and mild cognitive impairment. Researchers compare it with a patient education group. It is a Phase 2 trial, testing whether it works and is safe, not yet proven.

You may qualify if

  • 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

You're excluded if

  • 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

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2024-05-08

View full record on ClinicalTrials.gov

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