Treating Insomnia in Mild Cognitive Impairment
Recruiting now · Not applicable
Conditions studied: Mild Cognitive Impairment (MCI), Insomnia
In brief
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.
Key facts
- Study ID
- NCT06687161
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 30
- Starts
- 2025-05-01
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2025-10-24
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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