RECRUITING

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

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Conditions

InsomniaCognitive DysfunctionMild Cognitive ImpairmentSleep Initiation and Maintenance DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesAlzheimer DiseaseAlzheimer's diseaseCognitive behavioral therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Internet-based Insomnia Intervention to Prevent Cognitive Decline in Older Adults With Mild Cognitive Impairment (SHUTi MIND)

Quick Facts

Study Start:2023-02-27
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05565833

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Male or female, aged ≥ 65 years of age.
  4. * Able to speak and read English, and is a US resident.
  5. * Have access to any Internet-enabled device (computer, tablet, smartphone) and willing to be emailed about the study.
  6. * Sleep-onset insomnia and/or sleep maintenance insomnia symptoms
  7. * 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.
  8. * Cognitive impairment through study assessment.
  9. * Stable medication regimen unless medication is known to cause insomnia
  1. * Current psychological treatment for insomnia
  2. * Initiation of psychological or psychiatric treatment within the past three months
  3. * Current diagnosis of Huntington's or Parkinson's disease
  4. * Current treatment for hyperthyroidism
  5. * Currently undergoing chemotherapy
  6. * Presence of asthma or respiratory concerns with night treatment
  7. * Chronic pain treated with opioids
  8. * Not recovered from a brain tumor, injury, or infection
  9. * Epilepsy without stable treatment for at least 3 months
  10. * Irregular sleep schedule
  11. * Use of stimulating medications after 5pm or taken for less than 3 months
  12. * Psychotic or bipolar disorder
  13. * Moderate to high risk of suicide
  14. * Alcohol or drug abuse within the past year
  15. * Other untreated sleep disorders (e.g., obstructive sleep apnea)
  16. * Study screen for severe depression

Contacts and Locations

Study Contact

Meghan K Mattos, PhD, RN, CNL
CONTACT
434-243-3936
ms2bv@virginia.edu

Principal Investigator

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

Study Locations (Sites)

University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: University of Virginia

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-27
Study Completion Date2028-01

Study Record Updates

Study Start Date2023-02-27
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • Insomnia
  • Alzheimer's disease
  • Mild cognitive impairment
  • Cognitive behavioral therapy

Additional Relevant MeSH Terms

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