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Treating Insomnia in Mild Cognitive Impairment
Recruiting
Neuromodulation and Cognitive Behavioral Therapy for Insomnia in MCI
Who can join
Ages 60 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Transcranial Magnetic Stimulation (TMS) therapy (device)
- Cognitive behavioral therapy for insomnia (CBT-I) (behavioral)
Sponsor: Beth Israel Deaconess Medical Center · Participants: 30 · Started: May 1, 2025
Contact the study team
- Alex Clinical Research Coordinator · Phone: 617-667-0386
- Peter J Fried, PhD · Phone: 617-807-0612
Official record on ClinicalTrials.gov — NCT06687161
Locations in the U.S.
| Massachusetts | Beth Israel Deaconess Medical Center, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.