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NCT Number: NCT07014982

Remote Assessment of Digital Neurologic Testing

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location contact

Ashley Clinical Research Coordinator

CONTACT

[email protected]

507-284-0695

David T Jones, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Duration in slow wave sleep

    Time frame: 17 weeks

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

  2. Proportion in slow wave sleep

    Time frame: 17 weeks

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

  3. Perceived Stress Scale

    Time frame: 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 outcomes

  1. Patient Health Questionnaire 9-item (PHQ-9)

    Time frame: 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.

  2. General Anxiety Disorder 7-item (GAD-7)

    Time frame: 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.

  3. Cognitive Performance

    Time frame: 17 weeks

    Investigators will test patients' cognitive performance at the beginning, interim, and conclusion of the study using Mayo Speech Test.

  4. Cognitive Performance

    Time frame: 17 weeks

    Investigators will test patients' cognitive performance at the beginning, interim, and conclusion of the study using Mayo Test Drive.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Clinical Research Coordinator

CONTACT

[email protected]

507-284-0695

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Remote Assessment of Digital Neurologic Testing (RADiaNT)

Acronym: RADiaNT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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