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)
Conditions
Mild Cognitive Impairment (MCI)Insomnia
Locations
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States