Neurology
Conditions
Keywords
Neurology
Brief summary
The RADiaNT study investigates whether guided meditation, using the Muse™ headband and biofeedback app, can improve sleep, mood, and cognitive performance, aiming to assess its impact on mental and emotional well-being.
Interventions
BEHAVIORALGuided Meditation
Participants who complete guided meditation will be asked to meditate for 5 minutes a day, five times a week for two 6-week periods.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study will have two cohorts; one intervention cohort and one control cohort.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Cognition unimpaired or mild cognitive impairment * Fluent in English * United States resident * Able to tolerate wearing Muse headband * basic competence in using electronic devices (Smartphone or tablet) to engage with the Muse application and complete digital surveys and assessments
Exclusion criteria
* Neurological and Brain Disorders * Not Fluent in English * Not a US Resident * Unable to tolerate wearing Muse Headband
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration in slow wave sleep | 17 weeks | Total duration of sleep time spent in slow wave sleep (delta), reported in minutes |
| Proportion in slow wave sleep | 17 weeks | Proportion is the percentage of sleep time spent in slow wave sleep (delta) |
| Perceived Stress Scale | 17 weeks | Investigators will ask patients to answer the PSS questionnaire at the beginning, interim, and end of the study to see if there were any improvements in sleep quality over the intervention periods. This questionnaire is on a scale that scores 0-40, with the higher the score being a higher level of stress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire 9-item (PHQ-9) | 17 weeks | The Patient Health Questionnaire 9-item (PHQ-9) scale used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression. |
| General Anxiety Disorder 7-item (GAD-7) | 17 weeks | The General Anxiety Disorder 7-item (GAD 7) scale to assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety. |
| Cognitive Performance | 17 weeks | Investigators will test patients' cognitive performance at the beginning, interim, and conclusion of the study using Mayo Speech Test. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Jones, MD
Mayo Clinic
Outcome results
None listed