Improving sleep in older adults with mild cognitive impairment using brain stimulation and CBT-I
Neuromodulation and Cognitive Behavioral Therapy for Insomnia in MCI
This trial will try combining gentle transcranial magnetic stimulation (TMS) with cognitive behavioral therapy for insomnia (CBT-I) to improve sleep in people aged 60 and older who have mild cognitive impairment or subjective cognitive decline.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06687161 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 60 or older with a clinical diagnosis of MCI or subjective cognitive impairment who have current insomnia symptoms, can consent, and have access to an internet-enabled tablet or computer for remote testing.
Not a fit: People with significant cognitive impairment or dementia, uncontrolled moderate-to-severe obstructive sleep apnea or other untreated sleep disorders, contraindications to TMS or MRI, or who are already in psychological treatment for insomnia are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the combined TMS and CBT-I approach could meaningfully improve sleep quality and possibly help preserve cognitive function in people with MCI.
How similar studies have performed: CBT-I is well established for treating insomnia, TMS for sleep-related outcomes has shown mixed and early-stage results, and combining TMS with CBT-I in MCI is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.