Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT06687161

Treating Insomnia in Mild Cognitive Impairment

Led by Beth Israel Deaconess Medical Center · Updated on 2025-10-24

30

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

Sponsors

B

Beth Israel Deaconess Medical Center

Lead Sponsor

U

University of Virginia

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Treating Insomnia in Mild Cognitive Impairment

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 60 years or older
  • Speak and read English
  • Clinical diagnosis of mild cognitive impairment (MCI) or subjective cognitive impairment (SCI)
  • Reported insomnia symptoms causing significant distress or impairment for at least 3 months
  • Access to an internet-enabled computer or tablet at home, or ability to use a BIDMC-provided tablet with internet
  • Willing and able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Evidence of significant cognitive impairment or dementia
  • Contraindications for transcranial magnetic stimulation (TMS) or MRI
  • Currently receiving psychological treatment for insomnia
  • Uncontrolled moderate-to-severe obstructive sleep apnea or other untreated sleep disorders
  • Diagnosis of Parkinson's disease, Huntington's disease, Lewy-Body disease, or other neurological conditions affecting sleep
  • Current major psychiatric disorder (except well-controlled depression or anxiety)
  • Current use of opiate/opioid medications
  • Alcohol or drug abuse within the past year
  • Irregular sleep schedule outside specified bedtime and wake time unless willing to change

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

A

Alex Clinical Research Coordinator

CONTACT

P

Peter J Fried, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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