Back to Trials
NCT06687161NARecruiting

Treating Insomnia in Mild Cognitive Impairment

Beth Israel Deaconess Medical Center

Start Date

5/1/2025

Completion Date

6/30/2028

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 Criteria

Age Range: 60 years to No maximum

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.

Interventions

DEVICE

Transcranial Magnetic Stimulation (TMS) therapy

BEHAVIORAL

Cognitive behavioral therapy for insomnia (CBT-I)

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Mild Cognitive Impairment (MCI)Insomnia

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States