Remote Assessment of Digital Neurologic Testing

Mayo Clinic40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neurology

Interventions

Guided MeditationBEHAVIORAL

Participants who complete guided meditation will be asked to meditate for 5 minutes a day, five times a week for two 6-week periods.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

Duration in slow wave sleep

Total duration of sleep time spent in slow wave sleep (delta), reported in minutes

Time frame: 17 weeks

Proportion in slow wave sleep

Proportion is the percentage of sleep time spent in slow wave sleep (delta)

Time frame: 17 weeks

Perceived Stress Scale

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.

Time frame: 17 weeks

Secondary Outcomes

Patient Health Questionnaire 9-item (PHQ-9)

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.

Time frame: 17 weeks

General Anxiety Disorder 7-item (GAD-7)

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.

Time frame: 17 weeks

Central Contacts

Ashley Clinical Research Coordinator

CONTACT

507-284-0695 MCRadiantStudy@mayo.edu

Data from ClinicalTrials.gov

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