Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456502
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-06
Brief Title:
Effectiveness of Non-invasive Neuromodulation in Patients With Long-COVID
Sponsor:
Universidad Rey Juan Carlos
Organization:
Universidad Rey Juan Carlos
Study Overview
Official Title:
Effectiveness of Non-invasive Neuromodulation Compared to Placebo on Sleep Quality in Patients With Post-COVID Symptoms a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Sleep quality and duration are critical to cognitive emotional and physical well-being and poor sleep quality has been associated with an increased risk of cognitive psychological and cardiometabolic disorders Several important physiological activities occur during sleep including a reduction in heart rate and blood pressure In addition sleep exerts important modulatory effects on hormone release Previous studies have shown that lack of sleep can generate exaggerated cortisol responses or psychological and physiological stressors Cortisol has widespread effects throughout the body and brain affecting mood arousal energy metabolic processes and immune and inflammatory system functioning Therefore disruptions in cortisol secretion during the night can influence a wide variety of processes in our body that may contribute to the perception of poorer sleep quality In addition the salivary enzyme α-amylase is considered a biomarker of cognitive psychosocial emotional or physical stress It is important to note that the autonomic nervous system ANS regulates several physiological processes including heart rate blood pressure respiration and digestion The ANS consists primarily of the sympathetic system and the parasympathetic system Increased parasympathetic activity is considered to promote health whereas a dominant or overactive sympathetic branch is considered to be detrimental to health
A recent study found that both sleep quality and quantity of sleep were associated with resting ANS functioning They found that poorer sleep quality was associated with greater sympathetic dominance Research on the sympathetic and parasympathetic branches of the ANS has shown that autonomic imbalances are precursors to disease formation and other health-related risks Coronavirus disease 2019 COVID-19 has in many cases involved the presence of long-lasting symptoms several weeks or months after surviving acute infection with the virus leading to a new disease called long COVID-19 or post-COVID-19 syndrome PCS A recent study showed that sleep quality influences the relationship between symptoms associated with sensitization and mood disorders with health-related quality of life in people suffering from long COVID
Non-invasive neuromodulation directed to ANS may be an option to treat the sleep disorders observed in patients with long COVID
OBJETIVES
Therefore the primary objective of this study is to evaluate the efficacy of a treatment protocol on the ANS by means of non-invasive neuromodulation in aspects related to sleep in long COVID patients compared to placebo As secondary objectives we propose to evaluate the efficacy of a treatment protocol on the ANS by non-invasive neuromodulation in aspects related to ANS functioning psychological variables fatigue pain perception and quality of life in patients with long COVID
A recent study found that both sleep quality and quantity of sleep were associated with resting ANS functioning They found that poorer sleep quality was associated with greater sympathetic dominance Research on the sympathetic and parasympathetic branches of the ANS has shown that autonomic imbalances are precursors to disease formation and other health-related risks Coronavirus disease 2019 COVID-19 has in many cases involved the presence of long-lasting symptoms several weeks or months after surviving acute infection with the virus leading to a new disease called long COVID-19 or post-COVID-19 syndrome PCS A recent study showed that sleep quality influences the relationship between symptoms associated with sensitization and mood disorders with health-related quality of life in people suffering from long COVID
Non-invasive neuromodulation directed to ANS may be an option to treat the sleep disorders observed in patients with long COVID
OBJETIVES
Therefore the primary objective of this study is to evaluate the efficacy of a treatment protocol on the ANS by means of non-invasive neuromodulation in aspects related to sleep in long COVID patients compared to placebo As secondary objectives we propose to evaluate the efficacy of a treatment protocol on the ANS by non-invasive neuromodulation in aspects related to ANS functioning psychological variables fatigue pain perception and quality of life in patients with long COVID
Detailed Description:
None
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