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Treating Insomnia in Mild Cognitive Impairment | Clinical Trials | Clareo Health

RECRUITINGNA

Treating Insomnia in Mild Cognitive Impairment

Neuromodulation and Cognitive Behavioral Therapy for Insomnia in MCI

NCT06687161•Beth Israel Deaconess Medical Center

Summary

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.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 60 years or older
•Speak and read English
•Clinical diagnosis of MCI or Subjective Cognitive Impairment (SCI)-a perceived gradual worsening in cognitive ability relative to one's younger self, or peer group-reported by either the participant or informant
•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
•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
•Capable of and willing to provide written informed consent

Exclusion Criteria

•Evidence of significant cognitive impairment or dementia
•Contraindications for TMS or MRI
•Current psychological treatment for insomnia
•Uncontrolled moderate-to-severe obstructive sleep apnea or other untreated sleep disorder (e.g., Restless Leg Syndrome, Periodic Limb Movement Disorder, parasomnia). Sleep apnea that is managed (e.g., regular use of a CPAP) and stable for ≥3 months is allowed.
•Diagnosis of Parkinson's disease, Huntington's disease, Lewy-Body disease, or other neurological condition known to impact sleep
•Current diagnosis of major psychiatric disorder (well-controlled depression or anxiety is permitted)
•Current opiate/opioid use
•Alcohol or drug abuse within the past year
•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.

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Key Dates

Start Date

May 1, 2025

Primary Completion Date

June 30, 2028

Completion Date

June 30, 2028

Last Updated

October 24, 2025

Enrollment

ESTIMATED participants

Conditions

Mild Cognitive Impairment (MCI)Insomnia

Interventions

Transcranial Magnetic Stimulation (TMS) therapy

DEVICE

Cognitive behavioral therapy for insomnia (CBT-I)

BEHAVIORAL

Contacts

Alex Clinical Research Coordinator

CONTACT

617-667-0386 adiamon2@bidmc.harvard.edu

Peter J Fried, PhD

CONTACT

617-807-0612 pfried@bidmc.harvard.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treating Insomnia in Mild Cognitive Impairment

Inclusion Criteria

Exclusion Criteria

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