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

NCT06456502 | Recruiting

• 1 other identifier: 230220241322024
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Long-COVID; Post-acute COVID-19 Syndrome

Keywords

Post acute COVID-19 syndrome; Long-COVID; Non-invasive neuromodulation; Sleep quality; Depression; Anxiety; Fatigue; Quality of life; Pain

Outcome Measures

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.

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

Secondary Outcomes (6)

• Heart variability

  Baseline and at 8 weeks

• Cortisol and alpha amylase levels

  Baseline and at 8 weeks

• Psychological variables

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

• The quality of life

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

• Disability

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

Study Arms (2)

Non-invasive neuromodulation

EXPERIMENTAL

The real treatment group using non-invasive neuromodulation

Device: Non-invasive neuromodulation

PLACEBO

PLACEBO COMPARATOR

The placebo treatment group (simulation of non-invasive neuromodulation application).

Other: Placebo

Interventions

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).

Non-invasive neuromodulation

Placebo OTHER

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).

PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Rey Juan Carlos University

Alcorcón, Madrid, 28922, Spain

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Sleep Initiation and Maintenance Disorders; Depression; Anxiety Disorders; Fatigue; Pain

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms; Neurologic Manifestations

Study Officials

• Stella Fuensalida Novo, PhD

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stella Fuensalida Novo, PhD

CONTACT

+34914884865; stella.fuensalida@urjc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assignment to each group will be done by randomization software performed blindly by an external investigator who will not perform the interventions with the patients. Assessment will be performed by two persons of the team, not involved in the treatment. Participants will be blinded as they do not feel anything during the stimulation (whether within the active or placebo group), just the care provider will know if the cable is attached or not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Model Details: two armed parallel randomized clinical trial

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 13, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)