COVID-19, Post Acute Sequelae of SARS-CoV-2
Conditions
Keywords
Covid-19, PASC, Pandemic, Meditation
Brief summary
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.
Detailed 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.
Interventions
DEVICEMuse 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).
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects will receive and use the Muse S™ Headband system
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stress | 3 months post-baseline | 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. The outcome measure is change in stress from baseline at 3 months (end of treatment). Negative changes indicate decreased stress relative to baseline. |
| Change in Anxiety | 3 months post-baseline | PROMIS Emotional Distress-short form 7a (7 items). The PROMIS Anxiety item banks assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety. The raw scores were converted to t-scores using published guidelines (see PROMIS website). A T-score of 50 is the average for the general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured; thus, an increase in emotional distress T score corresponds to more anxiety - which is a worse outcome. |
Countries
United States
Participant flow
Recruitment details
Patients with Post-Covid Syndrome were recruited from the Long Covid Clinic at the Mayo Clinic Rochester Site.
Participants by arm
| Arm | Count |
|---|---|
| Muse S™ Headband System for Post-Covid Syndrome 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).
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). | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
Baseline characteristics
| Characteristic | Muse S™ Headband System for Post-Covid Syndrome |
|---|---|
| Age, Continuous | 47.6 years STANDARD_DEVIATION 12.5 |
| Race/Ethnicity, Customized race/ethnicity other | 2 Participants |
| Race/Ethnicity, Customized race/ethnicity White, Non-Hispanic | 43 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 1 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Change in Anxiety
PROMIS Emotional Distress-short form 7a (7 items). The PROMIS Anxiety item banks assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety. The raw scores were converted to t-scores using published guidelines (see PROMIS website). A T-score of 50 is the average for the general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured; thus, an increase in emotional distress T score corresponds to more anxiety - which is a worse outcome.
Time frame: 3 months post-baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Muse S™ Headband System for Post-Covid Syndrome | Change in Anxiety | -4.5 units on a scale | Standard Deviation 5.5 |
p-value: <0.001t-test, 2 sided
Primary
Change in 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. The outcome measure is change in stress from baseline at 3 months (end of treatment). Negative changes indicate decreased stress relative to baseline.
Time frame: 3 months post-baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Muse S™ Headband System for Post-Covid Syndrome | Change in Stress | -5.0 units on a scale | Standard Deviation 5.3 |
p-value: <0.001t-test, 2 sided