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Treating Insomnia in Mild Cognitive Impairment

NCT06687161 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-24

No results posted yet for this study

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

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)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06687161 on ClinicalTrials.gov