Remote Assessment of Digital Neurologic Testing

NCT07014982 | Not Yet Recruiting

• 1 other identifier: 24-013687
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurology

Keywords

Neurology

Outcome Measures

Primary Outcomes (3)

• Duration in slow wave sleep

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

  17 weeks

• Proportion in slow wave sleep

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

  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.

  17 weeks

Secondary Outcomes (4)

• Patient Health Questionnaire 9-item (PHQ-9)

  17 weeks

• General Anxiety Disorder 7-item (GAD-7)

  17 weeks

• Cognitive Performance

  17 weeks

• Cognitive Performance

  17 weeks

Study Arms (2)

Guided Meditation

EXPERIMENTAL

This cohort will be practicing guided meditation for 5 days/week, five minutes a day for 6 weeks. Then there will be a period of testing followed by another 6 week period of practicing guided meditation.

Behavioral: Guided Meditation

Standard of Care

NO INTERVENTION

This cohort will be asked to complete neurologic testing at baseline, interim, and conclusion periods while conducting NO guided meditation throughout the duration of the study.

Interventions

Guided Meditation BEHAVIORAL

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

Guided Meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Neurological and Brain Disorders
• Not Fluent in English
• Not a US Resident
• Unable to tolerate wearing Muse Headband

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

• David Jones, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Clinical Research Coordinator

CONTACT

507-284-0695; MCRadiantStudy@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will have two cohorts; one intervention cohort and one control cohort.

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 11, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)