Treating Insomnia in Mild Cognitive Impairment

October 23, 2025 updated by: Peter J. Fried, Beth Israel Deaconess Medical Center

Neuromodulation and Cognitive Behavioral Therapy for Insomnia in MCI

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: Transcranial Magnetic Stimulation (TMS) therapy
Each treatment consists of 600 TMS pulses (~3 minutes) applied to the L-DLPFC
Other Names:
  • Intermittent theta-burst stimulation (iTBS)
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)
Other Names:
  • SHUTi OASIS
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
Device: Transcranial Magnetic Stimulation (TMS) therapy
Each treatment consists of 600 TMS pulses (~3 minutes) applied to the L-DLPFC
Other Names:
  • Intermittent theta-burst stimulation (iTBS)
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)
Other Names:
  • SHUTi OASIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index
Time Frame: Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up)
The Insomnia Severity Index (ISI) is a brief self-assessment tool used to measure the severity of insomnia. It consists of seven questions that evaluate sleep problems, their impact on daily life, and the individual's level of concern about their sleep issues. The total score helps to categorize the severity of insomnia from mild to severe.
Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up)
Paired Associative Learning test (CANTAB)
Time Frame: Baseline, Week 3, Week 12, 6 Months
The Paired Associative Learning (PAL) test is a computer-based cognitive assessment that evaluates memory and learning. In the test, participants are shown patterns and must remember the locations of these patterns on a screen. It is commonly used to assess spatial memory and detect early signs of memory-related conditions like Alzheimer's disease.
Baseline, Week 3, Week 12, 6 Months
Spatial Working Memory test (CANTAB)
Time Frame: Baseline, Week 3, Week 12, 6 months
The Spatial Working Memory (SWM) test is a computer-based task used to assess the ability to retain and manipulate spatial information. Participants must find hidden tokens within a series of boxes while avoiding revisiting previously searched locations. This test measures executive function and memory, and is often used in research on conditions affecting cognitive function.
Baseline, Week 3, Week 12, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multidimensional Fatigue Symptoms Inventory
Time Frame: Baseline, Week 3, Week 12, 6 months
The Multidimensional Fatigue Symptom Inventory (MFSI) is a questionnaire designed to assess different aspects of fatigue. It measures five dimensions: general fatigue, emotional fatigue, physical fatigue, mental fatigue, and vigor (energy levels). The tool helps to provide a comprehensive understanding of an individual's fatigue symptoms and their impact on daily functioning.
Baseline, Week 3, Week 12, 6 months
Center for Epidemiologic Studies Depression scale
Time Frame: Baseline, Week 3, Week 12, 6 months
The Center for Epidemiologic Studies Depression scale (CES-D) is a self-report questionnaire designed to measure symptoms of depression in the general population. It consists of 20 questions that assess mood, behavior, and physical symptoms associated with depression over the past week. The CES-D is commonly used in research and clinical settings to screen for depressive symptoms and monitor changes in mood.
Baseline, Week 3, Week 12, 6 months
Match to Sample Visual Search test (CANTAB)
Time Frame: Baseline, Week 3, Week 12, 6 months
The Match to Sample Visual Search (MTS) test is a computerized assessment that measures visual recognition and attention. In the test, participants are shown a sample pattern and must quickly identify the matching pattern from a selection of similar images. It evaluates processing speed, visual memory, and attention to detail, and is often used to study cognitive functions in various neurological and psychiatric conditions.
Baseline, Week 3, Week 12, 6 months
Sleep efficiency (sleep diaries)
Time Frame: Week 3, Week 13, 6 months
Sleep Efficiency is a measure derived from sleep diaries that indicates the percentage of time spent asleep while in bed, relative to the total time spent in bed. It is calculated by dividing the total sleep time by the total time in bed and multiplying by 100 to get a percentage. A higher sleep efficiency typically suggests more consolidated sleep, while lower sleep efficiency can indicate difficulties with sleep onset or frequent awakenings.
Week 3, Week 13, 6 months
Sleep After Wake Onset (sleep diaries)
Time Frame: Week 3, Week 13, Week 40
Sleep After Wake Onset (SAWO) is a measure derived from sleep diaries that captures the amount of time a person manages to sleep after experiencing an initial awakening during the night. It represents the total time spent asleep between waking up and the final morning awakening, providing insight into the continuity of sleep and the ability to return to sleep after disruptions.
Week 3, Week 13, Week 40
Sleep Onset Latency (sleep diaries)
Time Frame: Week 3, Week 13, Week 40
Sleep Onset Latency (SOL) is a measure derived from sleep diaries that indicates the amount of time it takes to fall asleep after going to bed with the intention of sleeping. It is typically recorded in minutes and reflects how easily a person initiates sleep. Longer sleep onset latency may indicate difficulty falling asleep, while shorter latency suggests quicker sleep initiation.
Week 3, Week 13, Week 40
Sleep efficiency (actigraphy)
Time Frame: Week 3, Week 13, 6 months
Sleep Efficiency is a measure derived from actigraphy that indicates the percentage of time spent asleep while in bed, relative to the total time spent in bed. It is calculated by dividing the total sleep time by the total time in bed and multiplying by 100 to get a percentage. A higher sleep efficiency typically suggests more consolidated sleep, while lower sleep efficiency can indicate difficulties with sleep onset or frequent awakenings.
Week 3, Week 13, 6 months
Sleep After Wake Onset (actigraphy)
Time Frame: Week 3, Week 13, Week 40
Sleep After Wake Onset (SAWO) is a measure derived from actigraphy that captures the amount of time a person manages to sleep after experiencing an initial awakening during the night. It represents the total time spent asleep between waking up and the final morning awakening, providing insight into the continuity of sleep and the ability to return to sleep after disruptions.
Week 3, Week 13, Week 40
Sleep Onset Latency (actigraphy)
Time Frame: Week 3, Week 13, Week 40
Sleep Onset Latency (SOL) is a measure derived from actigraphy that indicates the amount of time it takes to fall asleep after going to bed with the intention of sleeping. It is typically recorded in minutes and reflects how easily a person initiates sleep. Longer sleep onset latency may indicate difficulty falling asleep, while shorter latency suggests quicker sleep initiation.
Week 3, Week 13, Week 40
Montreal Cognitive Assessment
Time Frame: Baseline, Week 3, Week 12, 6 months
The Montreal Cognitive Assessment (MoCA) is a quick test used by doctors and other healthcare professionals to check a person's thinking and memory skills. It takes about 10-15 minutes and looks at things like attention, memory, language, and problem-solving. It's often used to help spot early signs of conditions like dementia or mild cognitive impairment.
Baseline, Week 3, Week 12, 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortical Plasticity
Time Frame: Baseline (first day of TMS therapy)
Cortical plasticity is a measure of the efficacy of long-term potentiation (LTP)-neuroplasticity. It will be measured as the change in the TMS-evoked EEG potential (TEP) following iTBS.
Baseline (first day of TMS therapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Estimated)

October 24, 2025

Last Update Submitted That Met QC Criteria

October 23, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P000708
  • A2024034S (Other Grant/Funding Number: BrightFocus Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made available for qualified researchers approximately.

IPD Sharing Time Frame

Approximately 1 year following the conclusion of the study for at least 5 years

IPD Sharing Access Criteria

Researchers at universities and academic medical centers can request de-identified data by sending an email to the PI and describing the nature of the request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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