Non-Invasive Treatment for Post-COVID Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Courtney Wheatley-Guy

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Disqualifiers: Neurological disease, Stroke, Heart failure, others

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study aims to assess the effects of both acute and chronic exposures to hypoxia and hypercapnia in patients with Long COVID syndrome.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for post-COVID syndrome?

Research shows that hyperbaric oxygen therapy can improve cognitive function, psychiatric symptoms, pain, and fatigue in patients with post-COVID-19 condition by increasing brain blood flow and promoting brain healing.

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Is hyperbaric oxygen therapy safe for humans?

Hyperbaric oxygen therapy has been used in studies for post-COVID conditions and has shown improvements in cognitive and psychiatric symptoms without reported safety concerns, suggesting it is generally safe for humans.

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How does the Non-Invasive Treatment for Long COVID Brain Fog differ from other treatments for post-COVID syndrome?

This treatment is unique because it includes hyperbaric oxygen therapy, which can improve brain function and reduce symptoms like fatigue and pain by increasing oxygen flow to the brain and promoting brain healing. Unlike other treatments, it specifically targets brain connectivity and neuroplasticity, which are crucial for cognitive and emotional recovery in post-COVID patients.

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Eligibility Criteria

This trial is for English-speaking individuals who have been diagnosed with Long COVID and are experiencing mental fatigue. It's not suitable for those with a history of neurological diseases, severe lung or heart conditions, uncontrolled asthma, blood clots, kidney or liver disease, pregnant women, or those with a BMI over 40.

Inclusion Criteria

I have been diagnosed with Long COVID.

English speaking

Exclusion Criteria

I have a history of a brain-related disease like dementia or Alzheimer's.

I have had an aneurysm in the past.

My asthma is severe and not under control.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Exposure

Participants undergo acute exposure to hypoxia and hypercapnia through various interventions including Placebo, Progressive Carbon Dioxide, and Intermittent Hypoxia

14 days

Multiple visits during the 14-day intervention period

Training

Participants complete 6 cycles of either progressive CO2 ramp protocol or the intermittent hypoxia protocol for 60 minutes per visit

14 days

Multiple visits during the 14-day training period

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit within 7 days of final training visit

Participant Groups

The study is testing the effects of non-invasive treatments on brain fog in Long COVID patients. These include acute and training sessions with progressive carbon dioxide ramping (hypercapnia), intermittent hypoxic exposure (low oxygen), and placebo controls to compare results.

Group I: Training Group Experimental Treatment 2 Interventions

Training Study group will be complete 6 cycles of either progressive CO2 ramp protocol or the intermittent hypoxia protocol for 60 minutes for every visit during the 14 days. Subjects will then return within 7 days of their final training visit to repeat baseline testing

Group II: Acute exposure: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia Experimental Treatment 3 Interventions

Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Placebo, Intermittent Hypoxia

Group III: Acute exposure: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo Experimental Treatment 3 Interventions

Study group will receive the three interventions in this order: Progressive Carbon Dioxide, Intermittent Hypoxia, Placebo

Group IV: Acute exposure: Placebo, Progressive Carbon Dioxide, Intermittent Hypoxia Experimental Treatment 3 Interventions

Study group will receive the three interventions in this order: Placebo, Progressive Carbon Dioxide, then Intermittent Hypoxia

Group V: Acute exposure: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide Experimental Treatment 3 Interventions

Study group will receive the three interventions in this order: Placebo, Intermittent Hypoxia, Progressive Carbon Dioxide

Group VI: Acute exposure: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo Experimental Treatment 3 Interventions

Study group will receive the three interventions in this order: Intermittent Hypoxia, Progressive Carbon Dioxide, Placebo

Group VII: Acute exposure: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide Experimental Treatment 3 Interventions

Study group will receive the three interventions in this order: Intermittent Hypoxia, Placebo, Progressive Carbon Dioxide

Group VIII: Placebo Group Placebo Group 1 Intervention

Study group will complete 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air (60 minutes) for every visit during the 14 days intervention period. Subjects will then return within 7 days of their final training visit to repeat baseline testing

Non-invasive Treatment for Long COVID Brain Fog is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Non-invasive Neuromodulation for:

• Post-COVID-19 Condition
• Brain Fog

🇺🇸 Approved in United States as Non-invasive Neuromodulation for:

• Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
• Brain Fog

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic in Arizona Scottsdale, AZ

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy improves neurocognitive functions and symptoms of post-COVID condition: randomized controlled trial. [2022] Post-COVID-19 condition refers to a range of persisting physical, neurocognitive, and neuropsychological symptoms after SARS-CoV-2 infection. The mechanism can be related to brain tissue pathology caused by virus invasion or indirectly by neuroinflammation and hypercoagulability. This randomized, sham-control, double blind trial evaluated the effect of hyperbaric oxygen therapy (HBOT or HBO2 therapy) on post-COVID-19 patients with ongoing symptoms for at least 3 months after confirmed infection. Seventy-three patients were randomized to receive daily 40 session of HBOT (n = 37) or sham (n = 36). Follow-up assessments were performed at baseline and 1-3 weeks after the last treatment session. Following HBOT, there was a significant group-by-time interaction in global cognitive function, attention and executive function (d = 0.495, p = 0.038; d = 0.477, p = 0.04 and d = 0.463, p = 0.05 respectively). Significant improvement was also demonstrated in the energy domain (d = 0.522, p = 0.029), sleep (d = - 0.48, p = 0.042), psychiatric symptoms (d = 0.636, p = 0.008), and pain interference (d = 0.737, p = 0.001). Clinical outcomes were associated with significant improvement in brain MRI perfusion and microstructural changes in the supramarginal gyrus, left supplementary motor area, right insula, left frontal precentral gyrus, right middle frontal gyrus, and superior corona radiate. These results indicate that HBOT can induce neuroplasticity and improve cognitive, psychiatric, fatigue, sleep and pain symptoms of patients suffering from post-COVID-19 condition. HBOT's beneficial effect may be attributed to increased brain perfusion and neuroplasticity in regions associated with cognitive and emotional roles.

2. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen treatment for long coronavirus disease-19: a case report. [2022] The coronavirus disease 2019 pandemic has resulted in a growing population of individuals who experience a wide range of persistent symptoms referred to as "long COVID." Symptoms include neurocognitive impairment and fatigue. Two potential mechanisms could be responsible for these long-term unremitting symptoms: hypercoagulability, which increases the risk of blood vessel occlusion, and an uncontrolled continuous inflammatory response. Currently, no known treatment is available for long COVID. One of the options to reverse hypoxia, reduce neuroinflammation, and induce neuroplasticity is hyperbaric oxygen therapy. In this article, we present the first case report of a previously healthy athletic individual who suffered from long COVID syndrome treated successfully with hyperbaric oxygen therapy.

3. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric Oxygen Improves Neurocognitive Function and Symptoms of Post-COVID Condition. [2022] According to this study: Hyperbaric oxygen therapy can improve cognitive function, psychiatric symptoms, pain, and fatigue in patients who have post-COVID-19 condition.The beneficial effect of the therapy can be attributed to increased brain perfusion and neuroplasticity in regions associated with cognitive and emotional roles.

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of hyperbaric oxygen therapy on functional and structural connectivity in post-COVID-19 condition patients: A randomized, sham-controlled trial. [2022] Post-COVID-19 condition refers to a range of persisting physical, neurocognitive, and neuropsychological symptoms after SARS-CoV-2 infection. Abnormalities in brain connectivity were found in recovered patients compared to non-infected controls. This study aims to evaluate the effect of hyperbaric oxygen therapy (HBOT) on brain connectivity in post-COVID-19 patients.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Intranasal immunotherapy with M2 macrophage soluble factors in post-COVID hyposmia: A pilot study. [2023] Olfactory dysfunction is an early marker of COVID-19 infection. However, individuals may develop chronic olfactory impairment for more than six months in 1-10 % of cases. The study's objective is to evaluate the efficacy and safety of intranasal immunotherapy using bioactive substances produced by M2 macrophages for the treatment of people with long-term post-COVID-19 hyposmia. Seven individuals with long-term persistent hyposmia (7 to 24 months), associated with PCR-confirmed coronavirus infection were evaluated for olfactory function at baseline, one, and six to twelve months after therapy. The intranasal inhalation of M2 macrophage conditioned medum (one time per day for 28-30 days) was well tolerated. Furthermore, olfactometry demonstrated that the patients restored their capacity to perceive (Kruskal-Wallis H test 14.123, p = 0.0009) and recognize odours (H = 11.674, p = 0.0029). In addition, the subjective evaluation of smell significantly improved (H = 11.935, p = 0.0026). At the 6- to 12-month follow-up, the majority of patients (5/7) reported extremely high levels of satisfaction with the outcomes, and the remaining two patients also felt generally positive about the therapy's success. Overall, our study showed that the use of intranasal inhalations as a method of delivering bioactive factors and the conditioned medium of M2 macrophages as a therapeutic agent are both safe, well tolerated and, according to preliminary data, clinically effective in the treatment of patients with long-term post-COVID-19 hyposmia.

6. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for the treatment of long COVID: early evaluation of a highly promising intervention. [2023] Long COVID is a common occurrence following COVID-19 infection. The most common symptom reported is fatigue. Limited interventional treatment options exist. We report the first evaluation of hyperbaric oxygen therapy (HBOT) for long COVID treatment.

7. Germany pubmed.ncbi.nlm.nih.gov

Effects of classical olfactory training in patients with COVID-19-related persistent loss of smell. [2023] The management of post-COVID-19 persistent olfactory dysfunction (OD) is uncertain. Currently, olfactory training is the only evidence-based therapy for post-viral OD. In this study, we evaluated the effectiveness of classical olfactory training (COT) in the treatment of post-COVID-19 persistent OD.