- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05513846
Gehirnalter und Schlafarchitektur bei Meditierenden (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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02215
- Beth Israel Deaconess Medical Centre
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: CROSS_SECTIONAL
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Sleep Architecture - DREEM EEG
Zeitfenster: Measured across 5 nights (3 weekday and 2 weekend nights) during the data collection period.
|
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.
|
|
Brain Age
Zeitfenster: Measured for 3 weekday and 2 weekend nights during the data collection period
|
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
|
|
Sleep Measures - SleepImage Ring
Zeitfenster: 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).
|
|
Cognitive Function
Zeitfenster: Assessed once during the study period.
|
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.
|
|
Emotion
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Retrospective Meditation and Sleep Information
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 2022P000597
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