Clinical trial NCT06687161: Treating Insomnia in Mild Cognitive Impairment
Official title: Neuromodulation and Cognitive Behavioral Therapy for Insomnia in MCI
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Insomnia
Keywords: transcranial magnetic stimulation
neuromodulation
cognitive behavioral therapy
CBT-I
TMS
sleep
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: University of Virginia
First posted: 2024-11-13
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will test the combination of neuromodulation by repetitive transcranial magnetic stimulation (rTMS) with cognitive behavioral therapy for insomnia (CBT-I). All participants will receive the active intervention. Participants will be randomized to receive one or two treatments of rTMS per day.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Aged 65 years or older
* Speak and read English
* Clinical diagnosis of MCI
* 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).
* 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.

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up)
measure: Paired Associative Learning test (CANTAB)
timeFrame: Baseline, Week 3, Week 12, 6 Months
measure: Spatial Working Memory test (CANTAB)
timeFrame: Baseline, Week 3, Week 12, 6 months
Secondary outcomes:
measure: Multidimensional Fatigue Symptoms Inventory
timeFrame: Baseline, Week 3, Week 12, 6 months
measure: Center for Epidemiologic Studies Depression scale
timeFrame: Baseline, Week 3, Week 12, 6 months
measure: Match to Sample Visual Search test (CANTAB)
timeFrame: Baseline, Week 3, Week 12, 6 months
measure: Telephone Interview for Cognitive Status
timeFrame: Baseline, Week 3, Week 12, 6 months
measure: Sleep efficiency (sleep diaries)
timeFrame: Week 3, Week 13, 6 months
measure: Sleep After Wake Onset (sleep diaries)
timeFrame: Week 3, Week 13, Week 40
measure: Sleep Onset Latency (sleep diaries)
timeFrame: Week 3, Week 13, Week 40
measure: Sleep efficiency (actigraphy)
timeFrame: Week 3, Week 13, 6 months
measure: Sleep After Wake Onset (actigraphy)
timeFrame: Week 3, Week 13, Week 40
measure: Sleep Onset Latency (actigraphy)
timeFrame: Week 3, Week 13, Week 40
Other outcomes:
measure: Cortical Plasticity
timeFrame: Baseline (first day of TMS therapy)
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: