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SHUTi MIND: Internet-Delivered Therapy for Insomnia and Cognitive Health

This study is looking at how an internet-delivered cognitive behavioral therapy for insomnia (CBT-I) called SHUTi OASIS might help older adults (65 years and older) who have both insomnia and mild cognitive impairment. You would be compared to a group receiving patient education about insomnia. The researchers want to see if SHUTi OASIS can improve your sleep and also help with your memory, attention, and other thinking skills. To join, you need to be at least 65, speak and read English, live in the US, and have internet access. The study aims to enroll 144 participants. The main goal is to see if insomnia severity improves over 24 months.

Study design
This is a randomized controlled trial involving 144 participants. You would be assigned by chance to either the SHUTi OASIS program or an educational website.
What's involved
You would complete online cognitive tests, questionnaires, and sleep diaries before starting, and again at 9 weeks. You would also have access to your assigned online program for the duration of the study.
Compensation
Not stated in the trial record.
Follow-up
Your insomnia severity will be measured at 9 weeks, 6 months, 12 months, 18 months, and 24 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05565833

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

Recruiting
PHASE2Ages 65+InterventionalTreatment
University of Virginia
~144 participants
Updated 2024-05-08 on ClinicalTrials.gov
What's tested:SHUTi OASISPatient Education

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insomnia Severity Index
Measured over Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

Conditions

Insomnia
Cognitive Dysfunction
Mild Cognitive Impairment
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Alzheimer Disease

Explore related trials

InsomniaMild cognitive disorder

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Meghan K Mattos, PhD, RN, CNL · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Meghan K Mattos, PhD, RN, CNL
[email protected]
434-243-3936
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Insomnia Severity IndexBaseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

    Change in overall insomnia severity