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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Rey Juan Carlos

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy.

Pacemakers

Ulcerations or wounds in the area of electrode application.

Decompensated heart disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Non-invasive neuromodulation

    Device

    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).

  • Placebo

    Other intervention

    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).

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Non-invasive neuromodulationExperimental treatment 1 intervention
Group B: PLACEBOPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sleep quality

The aspects of sleep to be assessed by means of the Pittsburgh sleep quality index (PSQI) scale and the sleep diary to be completed each morning and handed in on the last day of treatment.

Time frame
Baseline, at the of 15th session, at 6 month an at one year

Secondary outcomes

1

Heart variability

Through the We Cardio device, which provides variables such as resting heart rate (HRV) and the root mean square difference of successive interval between two successive R-waves (RMSSD), which reflects beat-to-beat variation in heart rate and is the main time-domain measure used to estimate vagal (parasympathetic) changes reflected in HRV.

Time frame
Baseline and at 8 weeks
2

Cortisol and alpha amylase levels

Cortisol and alpha amylase levels will be assessed with salivary tests that will be analyzed using a Soma cube reader device.

Time frame
Baseline and at 8 weeks
3

Psychological variables

Depression and anxiety will be evaluated by means of the hospital anxiety and depression scale (HADS) validated in spanish and with a high level of reliability and sensitivity for these variables

Time frame
Baseline, at 8 weeks, at 6 month an at one year
4

The quality of life

This variable will be evaluated by means of the EuroQol 5D (EQ-5D). It is a standardized instrument developed to describe and assess health-related quality of life (HRQoL)

Time frame
Baseline, at 8 weeks, at 6 month an at one year

Other outcomes

Sponsors and contacts

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