Actively Recruiting

Phase 2
Age: 65Years +
All Genders
NCT05565833

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

Led by University of Virginia · Updated on 2024-05-08

144

Participants Needed

1

Research Sites

252 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form provided
  • Willingness to follow all study procedures and be available for the entire study duration
  • Male or female aged 65 years or older
  • Able to speak and read English and living in the US
  • Access to an Internet-enabled device and willing to receive emails about the study
  • Experiencing symptoms of sleep-onset insomnia and/or sleep maintenance insomnia
  • Sleep problems or daytime fatigue causing significant distress or impairment for at least 3 months
  • Mild cognitive impairment confirmed through study assessment
  • Medication regimen is stable unless medication is known to cause insomnia
Not Eligible

You will not qualify if you...

  • Currently receiving psychological treatment for insomnia
  • Started psychological or psychiatric treatment within the past 3 months
  • Diagnosis of Huntington's or Parkinson's disease
  • Receiving treatment for hyperthyroidism
  • Undergoing chemotherapy
  • Asthma or respiratory issues requiring night treatment
  • Chronic pain treated with opioids
  • Not recovered from brain tumor, injury, or infection
  • Epilepsy without stable treatment for at least 3 months
  • Irregular sleep schedule
  • Using stimulating medications after 5pm or used them for less than 3 months
  • Diagnosed with psychotic or bipolar disorder
  • Moderate to high suicide risk
  • Alcohol or drug abuse in the past year
  • Other untreated sleep disorders like obstructive sleep apnea
  • Severe depression identified during study screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Virginia

Charlottesville, Virginia, United States, 22908

Actively Recruiting

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Research Team

M

Meghan K Mattos, PhD, RN, CNL

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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