Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851846
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-10
First Post:
2023-05-08
Brief Title:
Amygdala Insula Retraining in the Management of Long COVID Symptoms
Sponsor:
Miami VA Healthcare System
Organization:
Miami VA Healthcare System
Study Overview
Official Title:
Amygdala Insula Retraining in the Management of Long COVID Symptoms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the study is to compare a mind body intervention against usual care in patients with fatigue with long COVID
Our research questions include
1 Is the mind body intervention additive to usual care in long COVID
2 Can the mind body intervention change laboratory markers heart rate variability and dysautonomia
Our research questions include
1 Is the mind body intervention additive to usual care in long COVID
2 Can the mind body intervention change laboratory markers heart rate variability and dysautonomia
Detailed Description:
More than 30 percent of the over 70 million individuals in the United States who experienced an acute COVID-19 infection as a result of severe acute respiratory coronavirus-2 SARS-CoV2 have variety of lingering and disabling symptoms that last beyond the acute phase of the illness 1This condition is referred to as Post-Acute Sequalae SARS-CoV-2 infection PASC Symptoms including fatigue post-exertional malaise PEM cardiovascular dysfunction respiratory distress gastrointestinal disturbances and dermatologic issues associated with PASC vary and can affect multiple organ systems These symptoms are similar to in extent and degree to other neuro-immune conditions such as Myalgic EncephalomyelitisChronic Fatigue Syndrome MECFS PASC as with MECFS is likely to pose a significant impact on the healthcare system and patients quality of life An unmet need exists as the susceptibility and pathogenesis of PASC remains yet to be fully elucidated Emerging evidence suggests that existing interventions widely used for other neuro-immune conditions may prove equally effective in the treatment of PASC Repurposing of drugs or identification of new drugs will take time Still there is growing evidence of the mind-body connection in modulating the autonomic central and peripheral nervous systems as well as the immune system and the gastrointestinal tract Recent studies have documented that holistic strategies such as mindfulness meditation and amygdala and insula retraining AIR have an objective measurable effect on heart rate variability fatigue pain quality of life depression anxiety and gastrointestinal symptoms The mechanisms proposed include activation of vagus nerve balancing the autonomic nervous system reducing stress and improving immune function AIR is based on the principle that viral bacterial or environmental insults can sensitize the amygdala which becomes hypervigilant and unleashes a cascade of hormonal responses that perpetuate a state of neuroinflammation and dysautonomia AIR de-sensitizes the amygdala breaking vicious cycles and reducing the maladaptive release of hormones and cytokines Our clinical group has already recommended the use of AIR with great anecdotical response in clinical practice This strategy is readily available and has no contraindications or risks We aim to conduct a pilot study of AIR to generate preliminary data for a larger federally funded trial Our specific aims are
1 Identify 130 subjects within the Miami Veterans Administration VA Medical Center who experienced an acute COVID-19 infection and continue to experience persistent moderate fatigue using standard questionnaires Subjects will be randomized to either 1 AIR standard of care or 2 Standard of carewait list Individuals in this latter arm will be waitlisted to receive the AIR intervention after they complete the study
2 Collect standard questionnaires recommended by the Veterans Affairs Healthcare System at baseline three and six months to capture levels of fatigue primary outcome post exertional malaise PEM brain fog pain and other symptoms and compare changes over time across the two study arms
3 Collect objective biometric data in a sample of patients at baseline and at three and six months to explore potential mediating mechanisms heart rate variability heart rate and blood pressure sitting and standing inflammatory markers c-reactive protein cortisol and Epstein Barr viral reactivation The laboratory tests will not be collected for research purposes as they are collected for clinical purposes
1 Identify 130 subjects within the Miami Veterans Administration VA Medical Center who experienced an acute COVID-19 infection and continue to experience persistent moderate fatigue using standard questionnaires Subjects will be randomized to either 1 AIR standard of care or 2 Standard of carewait list Individuals in this latter arm will be waitlisted to receive the AIR intervention after they complete the study
2 Collect standard questionnaires recommended by the Veterans Affairs Healthcare System at baseline three and six months to capture levels of fatigue primary outcome post exertional malaise PEM brain fog pain and other symptoms and compare changes over time across the two study arms
3 Collect objective biometric data in a sample of patients at baseline and at three and six months to explore potential mediating mechanisms heart rate variability heart rate and blood pressure sitting and standing inflammatory markers c-reactive protein cortisol and Epstein Barr viral reactivation The laboratory tests will not be collected for research purposes as they are collected for clinical purposes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None