RecruitingNot ApplicableNCT06687161

Treating Insomnia in Mild Cognitive Impairment

Neuromodulation and Cognitive Behavioral Therapy for Insomnia in MCI

Sponsor

Beth Israel Deaconess Medical Center

Enrollment

30 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Insomnia Mild Cognitive Impairment (MCI)

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

Min Age: 60 Years

Inclusion Criteria6

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 Criteria9

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.

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Interventions

DEVICETranscranial Magnetic Stimulation (TMS) therapy

Each treatment consists of 600 TMS pulses (\~3 minutes) applied to the L-DLPFC

BEHAVIORALCognitive behavioral therapy for insomnia (CBT-I)

9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness)