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Behandling av søvnløshet ved mild kognitiv svikt

3. november 2026 oppdatert av: Peter J. Fried, Beth Israel Deaconess Medical Center

Nevromodulering og kognitiv atferdsterapi for søvnløshet ved 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Rekruttering
        • Beth Israel Deaconess Medical Center
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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
Enhet: Transcranial Magnetic Stimulation (TMS) therapy

Each treatment consists of 600 TMS pulses (~3 minutes) applied to the L-DLPFC

Andre navn:
  • Intermitterende theta-burst-stimulering (iTBS)
Atferdsmessig: 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)

Andre navn:
  • SHUTi OASIS
Aktiv komparator: 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
Enhet: Transcranial Magnetic Stimulation (TMS) therapy

Each treatment consists of 600 TMS pulses (~3 minutes) applied to the L-DLPFC

Andre navn:
  • Intermitterende theta-burst-stimulering (iTBS)
Atferdsmessig: 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)

Andre navn:
  • SHUTi OASIS

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Insomnia Severity Index
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Multidimensional Fatigue Symptoms Inventory
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Montreal Cognitive Assessment
Tidsramme: 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
Sleep efficiency (sleep diaries)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cortical Plasticity
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Beth Israel Deaconess Medical Center

Samarbeidspartnere

University of Virginia

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2025

Primær fullføring (Antatt)

30. juni 2028

Studiet fullført (Antatt)

30. juni 2028

Datoer for studieregistrering

Først innsendt

12. november 2024

Først innsendt som oppfylte QC-kriteriene

12. november 2024

Først lagt ut (Faktiske)

13. november 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2024P000708
  • A2024034S (Annet stipend/finansieringsnummer: BrightFocus Foundation)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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