BridgeMD
New treatment option for Insomnia
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 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.
- 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's taking place
- 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 - 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?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.