NCT05565833 Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)
| NCT ID | NCT05565833 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Virginia |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2023-02-27 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 144 participants in total. It began in 2023-02-27 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Meghan K Mattos, PhD, RN, CNL
PRINCIPAL INVESTIGATOR
University of Virginia
Frequently Asked Questions
Who can join the NCT05565833 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05565833 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05565833 currently recruiting?
Yes, NCT05565833 is actively recruiting participants. Contact the research team at ms2bv@virginia.edu for enrollment information.
Where is the NCT05565833 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT05565833 clinical trial?
NCT05565833 is sponsored by University of Virginia. The principal investigator is Meghan K Mattos, PhD, RN, CNL at University of Virginia. The trial plans to enroll 144 participants.
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