Improving sleep in older adults with mild cognitive impairment using brain stimulation and CBT-I

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study pairs noninvasive neuromodulation (TMS) with a structured behavioral program (CBT-I) to target insomnia in people with mild cognitive impairment. Participants receive TMS sessions at the study site alongside guided CBT-I, with cognitive testing conducted using an internet-enabled device. The protocol excludes people with significant dementia, untreated sleep disorders like moderate-to-severe obstructive sleep apnea, or contraindications to TMS/MRI. Outcomes will focus on sleep quality and related functioning, and the team will monitor safety and tolerability in this older population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Alex Clinical Research Coordinator
• Email: adiamon2@bidmc.harvard.edu
• Phone: 617-667-0386

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.