Treating Insomnia in Mild Cognitive Impairment

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT06687161
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Magnetic Stimulation (TMS) therapy — DEVICE
    Each treatment consists of 600 TMS pulses (\~3 minutes) applied to the L-DLPFC
  • Cognitive behavioral therapy for insomnia (CBT-I) — BEHAVIORAL
    9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness)

Study Details

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 Dates

Start date
May 1, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: One (1) TMS treatment per day plus CBT-I
    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
  • Active Comparator: Two (2) TMS treatments per day plus CBT-I
    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

Primary Outcome Measure

Insomnia Severity Index [ Time Frame: Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Alex Clinical Research Coordinator
[email protected]
617-667-0386
Peter J Fried, PhD
[email protected]
617-807-0612

Find similar trials in Boston, MA

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Beth Israel Deaconess Medical Center· Boston, MA

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