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Recruiting NCT06687161

Treating Insomnia in Mild Cognitive Impairment

No phase Interventional Mild Cognitive Impairment (MCI) Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Magnetic Stimulation (TMS) therapy, Cognitive behavioral therapy for insomnia (CBT-I).
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment (MCI), Insomnia. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Neuromodulation and Cognitive Behavioral Therapy for Insomnia in MCI

Overview

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.

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)

Primary outcome measures

  • Insomnia Severity Index [Time frame: 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]
  • Spatial Working Memory test (CANTAB) [Time frame: Baseline, Week 3, Week 12, 6 months]
Secondary outcome measures (10)
  • Multidimensional Fatigue Symptoms Inventory [Time frame: Baseline, Week 3, Week 12, 6 months]
  • Center for Epidemiologic Studies Depression scale [Time frame: Baseline, Week 3, Week 12, 6 months]
  • Match to Sample Visual Search test (CANTAB) [Time frame: Baseline, Week 3, Week 12, 6 months]
  • Montreal Cognitive Assessment [Time frame: Baseline, Week 3, Week 12, 6 months]
  • Sleep efficiency (sleep diaries) [Time frame: Week 3, Week 13, 6 months]
  • Sleep After Wake Onset (sleep diaries) [Time frame: Week 3, Week 13, Week 40]
  • Sleep Onset Latency (sleep diaries) [Time frame: Week 3, Week 13, Week 40]
  • Sleep efficiency (actigraphy) [Time frame: Week 3, Week 13, 6 months]
  • Sleep After Wake Onset (actigraphy) [Time frame: Week 3, Week 13, Week 40]
  • Sleep Onset Latency (actigraphy) [Time frame: Week 3, Week 13, Week 40]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Beth Israel Deaconess Medical Center — Boston

Publications

  • Diamond AB, Fried PJ, Buss SS, Mullington JM, Brown JC, MacDonnell K, Mattos MK. Treating insomnia in mild cognitive impairment: a novel approach combining transcranial magnetic stimulation with cognitive behavioral therapy. Int Rev Psychiatry. 2026 May 19:1-17. doi: 10.1080/09540261.2026.2671089. Online ahead of print. PMID 42157607

Identifiers

NCT: NCT06687161 · 2024P000708 · A2024034S

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗