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Effectiveness of Non-invasive Neuromodulation in Patients With Long-COVID

U

Universidad Rey Juan Carlos

Status

Enrolling

Conditions

Long-COVID
Post-acute COVID-19 Syndrome

Treatments

Device: Non-invasive neuromodulation
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06456502
230220241322024

Details and patient eligibility

About

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.

Enrollment

44 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

44 participants in 2 patient groups, including a placebo group

Non-invasive neuromodulation
Experimental group
Description:
The real treatment group using non-invasive neuromodulation
Treatment:
Device: Non-invasive neuromodulation
PLACEBO
Placebo Comparator group
Description:
The placebo treatment group (simulation of non-invasive neuromodulation application).
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Stella Fuensalida Novo, PhD

Data sourced from clinicaltrials.gov

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