Edad cerebral y arquitectura del sueño en meditadores (BRANCH)
This is a single-center, cross-sectional study that will recruit approximately fifty seven (57) meditators and fifty one (51) controls. Individuals that have learned at least the Shambhavi Mahamudra Kriya practice and live in Massachusetts will be mailed a DREEM EEG device, and a sleepimage ring. Participants will be asked to wear the two devices while sleeping for three consecutive weekday nights (Sunday night to Thursday night) and two weekend nights (Friday and Saturday nights). While meditating during the day, participants will only wear the DREEM EEG headband. Participants will also undergo neurocognitive tests from the NIH toolbox during one virtual visit via video call. Meditators who join the study will be asked to invite a control subject to the study, matched for age and comorbidities.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Approximately one hundred and eight (108) individuals will undergo three consecutive weekday nights and two weekend nights of EEG and plethysmography recording using the DREEM headband and SleepImage rings, after answering a demographic questionnaire. Out of these 108 participants, the study will aim for 57 meditators and 51 matched controls. Only meditating participants will be asked to perform the most advanced form of meditation among the following three, which are listed from least advanced to most advanced: Shambhavi Mahamudra Kriya, Shoonya Meditation, Samyama Meditation (Breath watching). Participants will be instructed to wear the DREEM EEG headband during their practice of this meditation during each of the five days.
All participants will also be asked to undergo cognitive assessments from the NIH toolbox during a video call. The assessments from the NIH toolbox will last approximately forty-five minutes to one hour.
EEG: The participants will be mailed the DREEM devices and asked to wear them for three consecutive weekday nights and two weekend nights while sleeping. During the day, for each of these five nights, meditating participants will also be asked to wear the device while they sit still with their eyes closed, without trying to meditate, for 10 minutes. This will function as the baseline waking EEG measurement. Immediately following this, participants will be asked to perform their meditation while wearing the DREEM device for a maximum of 30 minutes.
NIH Toolbox:
This study will use select tests from the NIH Toolbox Cognition Battery and from the NIH Toolbox Emotion Battery. All of the tests together will take approximately 45 minutes to 1 hour to complete.
The selected tests from the batteries are the following:
Cognition Battery
- Picture vocabulary test
- List sorting working memory test
- Picture Sequence Memory test
- Oral reading recognition test
Emotion Battery:
- Positive Affect CAT
- General Life Satisfaction CAT
- Emotional Support FF
- Instrumental Support FF
- Friendship FF
- Loneliness FF
- Perceived Stress FF
Retrospective Survey:
Participants will also be asked to complete a retrospective questionnaire assessing meditation practice characteristics and alarm use during their original study participation.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Subjects will not be recruited based on race, ethnicity, or gender. However, it is not clear whether the final study sample will contain a representative spread of the racial and gender makeup.
Descripción
Inclusion Criteria (Meditators):
- Previous experience with learning Shambhavi Mahamudra Kriya
- Age 18 years or older.
- Lives in the United States barring California
Inclusion Criteria (Controls):
- Age 18 years or older
- Lives in the United States barring California
Exclusion Criteria (both groups):
- Non-English Speaking
- Night Shift workers
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: CROSS_SECTIONAL
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Meditation
This is the group that will have learned at least Shamhbavi Mahamudra Kriya before they are enrolled in the study. |
The DREEM EEG device will be used to measure brain age. The SleepImage ring uses plethysmography to analyze sleep architecture and cardiopulmonary coupling. |
|
Control
This is the group that will not have learned Shambhavi Mahamudra Kriya before they are enrolled in the study. They will be invited to the study by the Meditation group. |
The DREEM EEG device will be used to measure brain age. The SleepImage ring uses plethysmography to analyze sleep architecture and cardiopulmonary coupling. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sleep Architecture - DREEM EEG
Periodo de tiempo: Measured across 5 nights (3 weekday and 2 weekend nights) during the data collection period.
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Sleep architecture will be assessed using overnight DREEM EEG recordings. Measures will include including total sleep time, sleep efficiency, and sleep stage duration. Measures will be aggregated across available high-quality recordings for each participant. |
Measured across 5 nights (3 weekday and 2 weekend nights) during the data collection period.
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Brain Age
Periodo de tiempo: Measured for 3 weekday and 2 weekend nights during the data collection period
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Brain Age will be calculated using an algorithm from the sleeping EEG. A Brain Age index score will be created for each participant based on an aggregate of the five days of sleeping EEG data. The Brain Age Index is the brain age calculated from the algorithm subtracted by the chronological age of the participant. |
Measured for 3 weekday and 2 weekend nights during the data collection period
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Sleep Measures - SleepImage Ring
Periodo de tiempo: Measured across 5 nights (3 weekday and 2 weekend nights).
|
Sleep and cardiopulmonary measures will be assessed using the SleepImage Ring. |
Measured across 5 nights (3 weekday and 2 weekend nights).
|
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Cognitive Function
Periodo de tiempo: Assessed once during the study period.
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Cognitive function will be assessed using the NIH Toolbox Cognition Battery: Picture Vocabulary, List Sorting Working Memory, Picture Sequence Memory, and Oral Reading Recognition Tests. |
Assessed once during the study period.
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Emotion
Periodo de tiempo: Assessed once during the study period.
|
Emotional and psychosocial functioning will be assessed using the NIH Toolbox Emotion Battery: Positive Affect, General Life Satisfaction, Emotional Support, Instrumental Support, Friendship, Loneliness, and Perceived Stress measures. |
Assessed once during the study period.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Retrospective Meditation and Sleep Information
Periodo de tiempo: Assessed once retrospectively following study participation.
|
Meditators will report meditation type, frequency, and consistency; meditators and controls will report regular alarm use during the study period. |
Assessed once retrospectively following study participation.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
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
Otros números de identificación del estudio
- 2022P000597
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
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