Neuromodulation and Cognitive Behavioral Therapy for Insomnia in MCI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Insomnia Severity Index
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Insomnia Severity Index
Time Frame: Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up)
The Insomnia Severity Index (ISI) is a brief self-assessment tool used to measure the severity of insomnia. It consists of seven questions that evaluate sleep problems, their impact on daily life, and the individual's level of concern about their sleep issues. The total score helps to categorize the severity of insomnia from mild to severe.
Paired Associative Learning test (CANTAB)
Time Frame: Baseline, Week 3, Week 12, 6 Months
The Paired Associative Learning (PAL) test is a computer-based cognitive assessment that evaluates memory and learning. In the test, participants are shown patterns and must remember the locations of these patterns on a screen. It is commonly used to assess spatial memory and detect early signs of memory-related conditions like Alzheimer's disease.
Spatial Working Memory test (CANTAB)
Time Frame: Baseline, Week 3, Week 12, 6 months
The Spatial Working Memory (SWM) test is a computer-based task used to assess the ability to retain and manipulate spatial information. Participants must find hidden tokens within a series of boxes while avoiding revisiting previously searched locations. This test measures executive function and memory, and is often used in research on conditions affecting cognitive function.
Secondary Outcomes
- Center for Epidemiologic Studies Depression scale(Baseline, Week 3, Week 12, 6 months)
- Multidimensional Fatigue Symptoms Inventory(Baseline, Week 3, Week 12, 6 months)
- Center for Epidemiologic Studies Depression scale(Baseline, Week 3, Week 12, 6 months)
- Match to Sample Visual Search test (CANTAB)(Baseline, Week 3, Week 12, 6 months)
- Montreal Cognitive Assessment(Baseline, Week 3, Week 12, 6 months)
- Sleep efficiency (sleep diaries)(Week 3, Week 13, 6 months)
- Sleep After Wake Onset (sleep diaries)(Week 3, Week 13, Week 40)
- Sleep Onset Latency (sleep diaries)(Week 3, Week 13, Week 40)
- Sleep efficiency (actigraphy)(Week 3, Week 13, 6 months)
- Sleep After Wake Onset (actigraphy)(Week 3, Week 13, Week 40)
- Sleep Onset Latency (actigraphy)(Week 3, Week 13, Week 40)
Investigators
Peter J. Fried
Principal Investigator
Beth Israel Deaconess Medical Center