NCT05565833RecruitingPhase 2
Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)
Internet-based Insomnia Intervention to Prevent Cognitive Decline in Older Adults With Mild Cognitive Impairment (SHUTi MIND)
Source: ClinicalTrials.gov · Last updated 8 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 8 Sept 2022
- Start date
- 27 Feb 2023
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- University of Virginia
- Diseases
- Alzheimer disease
- NCT number
- NCT05565833
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 144
- From 27 Feb 2023 to the primary completion date, 31 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently undergoing chemotherapy
- Chronic pain treated with opioids
- Use of stimulating medications after 5pm or taken for less than 3 months
- Alcohol or drug abuse within the past year
Other illness
- Initiation of psychological or psychiatric treatment within the past three months
- Current diagnosis of Huntington's or Parkinson's disease
- Not recovered from a brain tumor, injury, or infection
- Epilepsy without stable treatment for at least 3 months
- Psychotic or bipolar disorder
- Other untreated sleep disorders (e.g., obstructive sleep apnea)
Other
- Current psychological treatment for insomnia
- Current treatment for hyperthyroidism
- Presence of asthma or respiratory concerns with night treatment
- Irregular sleep schedule
- Moderate to high risk of suicide
- Study screen for severe depression
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.