Health TrialsbyHealthPanel

Remote Assessment of Digital Neurologic Testing

ConditionNeurology
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Cognition unimpaired or mild cognitive impairment

Fluent in English

United States resident

Able to tolerate wearing Muse headband

Disqualifiers

Neurological and Brain Disorders

Not Fluent in English

Not a US Resident

Unable to tolerate wearing Muse Headband

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Guided MeditationExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Duration in slow wave sleep

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

Time frame
17 weeks
2

Proportion in slow wave sleep

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

Time frame
17 weeks
3

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

1

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
2

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
3

Cognitive Performance

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

Time frame
17 weeks
4

Cognitive Performance

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

Time frame
17 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: