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