Official Title
Effectiveness of Non-invasive Neuromodulation Compared to Placebo on Sleep Quality in Patients With Post-COVID Symptoms: a Randomized Clinical Trial.
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 activitiesoccur during sleep including a reduction in heart rate and blood pressure. In addition,sleep exerts important modulatory effects on hormone release. Previous studies have shownthat lack of sleep can generate exaggerated cortisol responses or psychological andphysiological stressors. Cortisol has widespread effects throughout the body and brain,affecting mood, arousal, energy, metabolic processes, and immune and inflammatory systemfunctioning. Therefore, disruptions in cortisol secretion during the night can influencea wide variety of processes in our body that may contribute to the perception of poorersleep quality. In addition, the salivary enzyme α-amylase is considered a biomarker ofcognitive, psychosocial, emotional or physical stress. It is important to note that theautonomic nervous system (ANS) regulates several physiological processes, including heartrate, blood pressure, respiration, and digestion. The ANS consists primarily of thesympathetic system and the parasympathetic system. Increased parasympathetic activity isconsidered to promote health, whereas a dominant or overactive sympathetic branch isconsidered to be detrimental to health.A recent study found that both sleep quality and quantity of sleep were associated withresting ANS functioning. They found that poorer sleep quality was associated with greatersympathetic dominance. Research on the sympathetic and parasympathetic branches of theANS has shown that autonomic imbalances are precursors to disease formation and otherhealth-related risks. Coronavirus disease 2019 (COVID-19), has in many cases involved thepresence of long-lasting symptoms several weeks or months after surviving acute infectionwith 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 betweensymptoms associated with sensitization and mood disorders with health-related quality oflife in people suffering from long COVID.Non-invasive neuromodulation directed to ANS may be an option to treat the sleepdisorders observed in patients with long COVID.OBJETIVES:Therefore, the primary objective of this study is to evaluate the efficacy of a treatmentprotocol on the ANS by means of non-invasive neuromodulation in aspects related to sleepin long COVID patients compared to placebo. As secondary objectives, we propose toevaluate the efficacy of a treatment protocol on the ANS by non-invasive neuromodulationin aspects related to ANS functioning, psychological variables, fatigue, pain perceptionand quality of life in patients with long COVID.

Detailed Description

Not Provided

Recruiting
LONG-COVID
Post-acute COVID-19 Syndrome

Device: Non-invasive neuromodulation

The treatment plan of non- invasive neuromodulation will be applied for two months, with
a frequency of 2 weekly sessions of one hour duration, until completing a total of 15
sessions for each patient. The sessions will always be applied in the same time slot of
the day (to avoid influence on the measurements, specially cortisol).

Other: Placebo

The treatment plan of placebo will be applied for two months, with a frequency of 2
weekly sessions of one hour duration, until completing a total of 15 sessions for each
patient. Participants will be attached to the neuromodulation machine, however, the cable
will not be connected. Participants will not be able to see the machine connections. The
sessions will always be applied in the same time slot of the day (to avoid influence on
the measurements, specially cortisol).

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
Locations

Rey Juan Carlos University
Alcorcón, Madrid, Spain

Investigator: Stella Fuensalida Novo, PhD
Contact: +34914884865
stella.fuensalida@urjc.es

Contacts

Stella Fuensalida Novo, PhD
+34914884865
stella.fuensalida@urjc.es

Stella Fuensalida Novo, PhD, Principal Investigator
Universidad Rey Juan Carlos

Universidad Rey Juan Carlos
NCT Number
Keywords
Post Acute COVID-19 Syndrome
Long-COVID
Non-invasive Neuromodulation
sleep quality
depression
Anxiety
Fatigue
Quality of Life
Pain
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome