NCT06687161

Treating Insomnia in Mild Cognitive Impairment

Neuromodulation and Cognitive Behavioral Therapy for Insomnia in MCI

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Cognitive Impairment (MCI)
• Insomnia

Interventions

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

Timeline

• Start date: 2025-05-01
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2024-11-13
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study