Effectiveness of Non-invasive Neuromodulation in Patients With Long-COVID
Unknown statusNot applicableNCT06456502
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 …
Study details
- Official title
- Effectiveness of Non-invasive Neuromodulation Compared to Placebo on Sleep Quality in Patients With Post-COVID Symptoms: a Randomized Clinical Trial.
- Conditions
- Long-COVID
- Post-acute COVID-19 Syndrome
- Interventions
- Device: Non-invasive neuromodulation
- Other: Placebo
- Sponsor
- Universidad Rey Juan Carlos
- Start date
- 2024-06
- Primary completion
- 2026-06-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Subjects with long COVID or post- acute COVID syndrome * With a evolution of at least 6 months after acute SARS-cov-2 infection * Whit symptoms present at baseline. Exclusion Criteria: * Pregnancy. * Pacemakers * Ulcerations or wounds in the area of electrode application. * Decompensated heart disease. * Epilepsy and/or choreic syndromes. * Frequent medication with corticosteroids, hypnotics or supplements such as melatonin, Ashwagandha or phosphatidylserine. * Hypersensitivity on hands and feet that influence the use of the gloves and socks from the neuromodulation system.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06456502