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- Ensayo clínico NCT06687161
Tratamiento del insomnio en casos de deterioro cognitivo leve
Neuromodulación y terapia cognitivo-conductual para el insomnio en el deterioro cognitivo leve
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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Peter J Fried, PhD
- Número de teléfono: 617-807-0612
- Correo electrónico: pfried@bidmc.harvard.edu
Copia de seguridad de contactos de estudio
- Nombre: Alex Clinical Research Coordinator
- Número de teléfono: 617-667-0386
- Correo electrónico: adiamon2@bidmc.harvard.edu
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Reclutamiento
- Beth Israel Deaconess Medical Center
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Contacto:
- Peter J Fried, PhD
- Número de teléfono: 617-807-0612
- Correo electrónico: pfried@bidmc.harvard.edu
-
Contacto:
- Alex Clinical Research Coordinator
- Número de teléfono: 617-667-0386
- Correo electrónico: adiamon2@bidmc.harvard.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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 |
Each treatment consists of 600 TMS pulses (~3 minutes) applied to the L-DLPFC
Otros nombres:
9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness)
Otros nombres:
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Comparador activo: 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 |
Each treatment consists of 600 TMS pulses (~3 minutes) applied to the L-DLPFC
Otros nombres:
9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness)
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Insomnia Severity Index
Periodo de tiempo: Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up)
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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)
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Paired Associative Learning test (CANTAB)
Periodo de tiempo: Baseline, Week 3, Week 12, 6 Months
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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
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Spatial Working Memory test (CANTAB)
Periodo de tiempo: Baseline, Week 3, Week 12, 6 months
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Multidimensional Fatigue Symptoms Inventory
Periodo de tiempo: Baseline, Week 3, Week 12, 6 months
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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
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Center for Epidemiologic Studies Depression scale
Periodo de tiempo: Baseline, Week 3, Week 12, 6 months
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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
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Match to Sample Visual Search test (CANTAB)
Periodo de tiempo: Baseline, Week 3, Week 12, 6 months
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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
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Montreal Cognitive Assessment
Periodo de tiempo: Baseline, Week 3, Week 12, 6 months
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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
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Sleep efficiency (sleep diaries)
Periodo de tiempo: Week 3, Week 13, 6 months
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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
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Sleep After Wake Onset (sleep diaries)
Periodo de tiempo: Week 3, Week 13, Week 40
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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
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Sleep Onset Latency (sleep diaries)
Periodo de tiempo: Week 3, Week 13, Week 40
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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
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Sleep efficiency (actigraphy)
Periodo de tiempo: Week 3, Week 13, 6 months
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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
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Sleep After Wake Onset (actigraphy)
Periodo de tiempo: Week 3, Week 13, Week 40
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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
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Sleep Onset Latency (actigraphy)
Periodo de tiempo: Week 3, Week 13, Week 40
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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
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cortical Plasticity
Periodo de tiempo: Baseline (first day of TMS therapy)
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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)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Trastornos neurocognitivos
- Trastornos cognitivos
- Trastornos del sueño y la vigilia
- Trastornos del Sueño Intrínsecos
- Disomnias
- Disfunción congnitiva
- Trastornos de iniciación y mantenimiento del sueño
- Terapia conductual
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Terapia de campo magnético
- Terapia cognitiva conductual
- Terapéutica
- Estimulación magnética transcraneal
Otros números de identificación del estudio
- 2024P000708
- A2024034S (Otro número de subvención/financiamiento: BrightFocus Foundation)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
De-identified data will be made available for qualified researchers approximately.
Marco de tiempo para compartir IPD
Approximately 1 year following the conclusion of the study for at least 5 years
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .