RECRUITING

Treating Insomnia in Mild Cognitive Impairment

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Conditions

Mild Cognitive Impairment (MCI)Insomniatranscranial magnetic stimulationneuromodulationcognitive behavioral therapyCBT-ITMSsleep

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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

The goal of this study is to test a new way to improve sleep quality in persons living with mild cognitive impairment. The treatment combines a safe and gentle way to stimulate the brain, called transcranial magnetic stimulation, with a psychological treatment, called cognitive behavioral therapy for insomnia.

Official Title

Neuromodulation and Cognitive Behavioral Therapy for Insomnia in MCI

Quick Facts

Study Start:2025-05-01
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06687161

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. * Aged 65 years or older
  2. * Speak and read English
  3. * Clinical diagnosis of MCI
  4. * Reported insomnia symptoms (sleep-onset and/or sleep maintenance) that cause significant distress or impairment in social, occupational, or other areas of functioning over the past three months
  5. * Have access to an Internet-enabled computer or tablet at home, or ability to connect a BIDMC-provided tablet to the internet, with private space to complete cognitive testing
  6. * Capable of and willing to provide written informed consent
  1. * Evidence of significant cognitive impairment or dementia
  2. * Contraindications for TMS or MRI
  3. * Current psychological treatment for insomnia
  4. * Uncontrolled moderate-to-severe obstructive sleep apnea or other untreated sleep disorder (e.g., Restless Leg Syndrome, Periodic Limb Movement Disorder, parasomnia).
  5. * Diagnosis of Parkinson's disease, Huntington's disease, Lewy-Body disease, or other neurological condition known to impact sleep
  6. * Current diagnosis of major psychiatric disorder (well-controlled depression or anxiety is permitted)
  7. * Current opiate/opioid use
  8. * Alcohol or drug abuse within the past year
  9. * Irregular sleep schedule (bedtime before 8pm/after 2am OR wake time before 4am/after 10am), unless participant states they are willing and able to change if prompted.

Contacts and Locations

Study Contact

Alex Clinical Research Coordinator
CONTACT
617-667-0386
adiamon2@bidmc.harvard.edu
Peter J Fried, PhD
CONTACT
617-807-0612
pfried@bidmc.harvard.edu

Study Locations (Sites)

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

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 Date2025-05-01
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

  • transcranial magnetic stimulation
  • neuromodulation
  • cognitive behavioral therapy
  • CBT-I
  • TMS
  • sleep

Additional Relevant MeSH Terms

  • Mild Cognitive Impairment (MCI)
  • Insomnia