Treating Insomnia in Mild Cognitive Impairment

Beth Israel Lahey Health

Status: Enrolling

Conditions: Mild Cognitive Impairment (MCI); Insomnia

Treatments: Device: Transcranial Magnetic Stimulation (TMS) therapy; Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)

Study type: Interventional

Funder types: Other

Identifiers

NCT06687161

2024P000708

A2024034S (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

One (1) TMS treatment per day plus CBT-I

Active Comparator group

Description:

One (1) daily treatment of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 10 days (2 weeks) followed by a 9-week Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program

Treatment:

Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)

Device: Transcranial Magnetic Stimulation (TMS) therapy

Two (2) TMS treatments per day plus CBT-I

Active Comparator group

Description:

Two (2) daily treatments, spaced 1 hour apart, of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 10 days (2 weeks) followed by a 9-week Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program

Treatment:

Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)

Device: Transcranial Magnetic Stimulation (TMS) therapy