What side effects are associated with this type of intervention?

Common treatments for Post-COVID Syndrome, particularly those aimed at reducing stress and anxiety, include mindfulness and meditation practices. These treatments are generally well-tolerated with minimal side effects. Some individuals may experience initial discomfort, such as increased anxiety or restlessness, as they begin to practice mindfulness or meditation. However, these symptoms typically decrease with continued practice. Other potential side effects can include mild headaches or fatigue, but these are rare and usually transient.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Post-COVID Syndrome that focus on meditation or mindfulness-based interventions similar to the Muse-S device. Most treatments for Post-COVID Syndrome are still under investigation, and non-pharmacologic approaches like meditation and mindfulness are generally recommended based on their potential benefits in reducing stress and anxiety, rather than through formal FDA approval.

What other types of research exist?

Promising alternatives to the Muse-S device for Post-COVID Syndrome patients include: 1) Mindfulness-Based Stress Reduction (MBSR) programs, which have shown efficacy in reducing stress and anxiety in various populations, including cancer survivors. 2) Cognitive Behavioral Therapy (CBT), particularly CBT for insomnia (CBT-I), which can help manage sleep disturbances and associated anxiety. 3) Acupuncture and acupressure, which have been considered for managing symptoms like nausea and pain, and may also help with stress and anxiety. 4) Yoga and meditation practices, which have been endorsed for their benefits in managing anxiety and stress. 5) Progressive muscle relaxation and guided imagery, which have shown benefits in reducing pain and improving overall well-being in cancer patients.

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Behavioural Intervention

Mindfulness Intervention for Post-COVID Syndrome

N/A

Waitlist Available

Led By Ivana Croghan, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.

Anyone that is not on a stable dose of medication for anxiety, depression or sleep.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post-baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial studies if using the Muse-S headband to practice meditation can help post-Covid patients with long-term symptoms feel less stressed and anxious.

Who is the study for?

This trial is for individuals who have had COVID-19 and are now experiencing long-term symptoms. Participants must not be pregnant, should have access to a smartphone or tablet, and be able to fully participate in the study. They should not have any health conditions that would affect using the Muse S™ headband and not be on unstable medication doses.

What is being tested?

The trial is testing whether a wearable brain sensing device called Muse S™ can help reduce stress and anxiety in people with lingering post-Covid symptoms by teaching them meditation practices.

What are the potential side effects?

While there may not be direct side effects from using the Muse S™ headband, participants might experience discomfort or frustration if they find it difficult to engage with mindfulness practices.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been practicing mindfulness regularly for the past 3 weeks.

Select...

I am not on a stable dose of medication for anxiety, depression, or sleep.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post-baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reducing Anxiety

Reducing Stress

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Muse S™ Headband system for post-Covid SyndromeExperimental Treatment1 Intervention

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).

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Post-COVID Syndrome, particularly those targeting stress and anxiety, include mindfulness meditation, cognitive-behavioral therapy (CBT), and other stress-reduction techniques. Devices like the Muse-S, which aid in learning meditation, work by promoting relaxation and reducing the physiological stress response. This is important for Post-COVID Syndrome patients because chronic stress and anxiety can worsen symptoms such as fatigue, dyspnea, and cognitive impairments. Effective stress management can improve overall quality of life and potentially alleviate other persistent symptoms.