Insomnia study: SHUTi OASIS vs Patient Education
Official title Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)
ClinicalTrials.gov ID: NCT05565833
What this study is testing
- What it's testing
- This study is testing whether an Internet-delivered sleep therapy improves sleep and memory in people with mild cognitive impairment.
- Who it's for
- You may be able to join if you have trouble falling or staying asleep and have mild memory problems.
- What's involved
- You will use a computer or phone to do a sleep program at home. You will also answer questions about your sleep and memory.
- Time commitment
- The study lasts about 12 weeks and includes a few online check‑ins during that time.
- Phase 2: a mid-size study of how well it works
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join 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.
You likely can't join 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
See the full eligibility 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
- 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 study team makes the final eligibility decision.
Where it is enrolling
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Charlottesville, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.