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Mindfulness Intervention for Post-Covid Symptoms

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Mayo Clinic

Status

Completed

Conditions

COVID-19
Post Acute Sequelae of SARS-CoV-2

Treatments

Device: Muse S™ Headband system

Study type

Interventional

Funder types

Other

Identifiers

NCT05199233
21-009820

Details and patient eligibility

About

The purpose of this study is to assess the feasibility of using a wearable brain-sensing wellness device (Muse-S) to potentially reduce stress and anxiety during Post-Covid, which is characterized by increased stress and anxiety.

Full description

This study will answer the following questions: 1) will patients experiencing Long-Covid Syndrome utilize a wearable brain-sensing wellness device to potentially reduce stress and anxiety 2) does using this wearable brain-sensing wellness device help decrease stress and anxiety in patients who are experiencing Long-Covid Syndrome.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

Muse S™ Headband system for post-Covid Syndrome
Experimental group
Description:
Subjects will utilize the Muse S™ Headband system at least 4 times per week for a minimum of 10 minutes each time over a period of 3 months (12 weeks).
Treatment:
Device: Muse S™ Headband system

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Gillian Currie, MBA, CCRP; Shawn Fokken, CCRP

Data sourced from clinicaltrials.gov

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