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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05199233
Other study ID # 21-009820
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date December 2024

Study information

Verified date December 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research is to study if post-Covid patients using a wearable brain sensing wellness device (Muse-S) to learn meditation practice during a time where they are experiencing lengthy Covid symptoms will help in decreasing stress and anxiety.


Description:

This study will answer the following question: does meditation help decrease stress and anxiety in patients who are experiencing long-haulers syndrome.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Identified with one of 3 Post-Covid Syndrome (PASC) phenotypes at Mayo Clinic Rochester. - Not pregnant by subject self-report at time of consent. - Have the ability to provide informed consent. - Have the ability to complete all aspects of this trial. - Have access to an iPhone, iPad, or Android device. - Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-SÔ system, as determined by the clinical investigators. Exclusion Criteria: - Used an investigational drug within the past 30 days. - Anyone that is not on a stable dose of medication for anxiety, depression or sleep. - Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis. - Currently (within 3 weeks) has been enrolled in another clinical or research program which intervenes on the patients' QOL, or stress. - An unstable medical or mental health condition as determined by the physician investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Muse S™ Headband system
Clinical grade, headband style, wireless EEG (electroencephalogram is a test used to evaluate the electrical activity in the brain) system and designed to interact with a mobile device (smartphone or tablet).

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reducing Stress Stress is evaluated through the Perceived Stress Scale (PSS). This is a 10-item Likert scale that measures global life stress by assessing the degree to which experiences are appraised as uncontrollable or unpredictable. Scores can range from 0 to 40, with higher scores indicating greater perceived stress. 3 months post-baseline
Primary Reducing Anxiety State-Trait Anxiety Inventory (STAI-Y1) will be used for measure anxiety. This 20 item self-report measure indicates the intensity of feelings of anxiety; it distinguishes between state anxiety (a temporary condition experienced in specific situations) and trait anxiety (a general tendency to perceive situations as threatening). This uses a 4-point visual analog scale and the participant indicates how they feel in the moment (1=not at all to 4=very much so). 3 months post-baseline
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