Long-COVIDNCT06456502
Effectiveness of Non-invasive Neuromodulation in Patients With Long-COVID
A study testing Non-invasive neuromodulation in people with Long-COVID and Post-acute COVID-19 Syndrome, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long-COVID, Post-acute COVID-19 Syndrome
- What is being tested?
- Non-invasive neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Rey Juan Carlos University
Alcorcón, Madrid, 28922
Stella Fuensalida Novo, PhD, +34914884865, stella.fuensalida@urjc.es
About this study
Official title: Effectiveness of Non-invasive Neuromodulation Compared to Placebo on Sleep Quality in Patients With Post-COVID Symptoms: a Randomized Clinical 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.
Read more
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
- Being tested
- Non-invasive neuromodulation, Placebo
- Keywords
- Post acute COVID-19 syndrome, Long-COVID, Non-invasive neuromodulation, Sleep quality, Depression, Anxiety, Fatigue, Quality of life, Pain
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Sleep Initiation and Maintenance Disorders, Depression, Anxiety Disorders, Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive neuromodulationDevice
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).
PlaceboOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive neuromodulation | Experimental | The real treatment group using non-invasive neuromodulation Receives: Device: Non-invasive neuromodulation |
| PLACEBO | Placebo comparator | The placebo treatment group (simulation of non-invasive neuromodulation application). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, at the of 15th session, at 6 month an at one year
Secondary outcomes (6)
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.
Measured: Baseline and at 8 weeks
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.
Measured: Baseline and at 8 weeks
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
Measured: Baseline, at 8 weeks, at 6 month an at one year
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)
Measured: Baseline, at 8 weeks, at 6 month an at one year
Disability
The impact of the disease on patients will be assessed using the severe acute respiratory syndrome (SARS) functional impairment checklist (FIC), which is a questionnaire that assesses physical and psychological symptoms, as well as disability-related domains. The FIC has been shown to be valid, to show good reliability and to exhibit good psychometric properties for use as a tool to assess physical symptoms and disability-related domains in patients with SARS and patients with persistent COVID.
Measured: Baseline, at 8 weeks, at 6 month an at one year
Pain intensity
Pain will be assessed by means of a numeric pain rating scale (NPRS), which allows measuring the intensity of pain described by the patient with maximum reproducibility between observers.
Measured: Baseline, at 8 weeks, at 6 month an at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study startJun 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two armed parallel randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stella María Fuensalida Novo, Universidad Rey Juan Carlos
- Investigators
- Stella Fuensalida Novo, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456502
- Sponsor's protocol ID
- 230220241322024
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Non-invasive Neuromodulation Compared to Placebo on Sleep Quality in Patients With Post-COVID Symptoms: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06456502
- Acronym / sponsor ID
- 230220241322024
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two armed parallel randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Non-invasive neuromodulation | Experimental | Device: Non-invasive neuromodulationThe real treatment group using non-invasive neuromodulation |
| PLACEBO | Placebo comparator | Other: PlaceboThe placebo treatment group (simulation of non-invasive neuromodulation application). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Pregnancy.
- Pacemakers
- Ulcerations or wounds in the area of electrode application.
- Decompensated heart disease.
- Epilepsy and/or choreic syndromes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive neuromodulationThe 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). | Device | Non-invasive neuromodulation |
| PlaceboThe 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). | Other | PLACEBO |
Primary outcome
Sleep quality
Time frame: Baseline, at the of 15th session, at 6 month an at one year
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.
6 secondary outcomes
Heart variability
Time frame: Baseline and at 8 weeks
Cortisol and alpha amylase levels
Time frame: Baseline and at 8 weeks
Psychological variables
Time frame: Baseline, at 8 weeks, at 6 month an at one year
The quality of life
Time frame: Baseline, at 8 weeks, at 6 month an at one year
Disability
Time frame: Baseline, at 8 weeks, at 6 month an at one year
Pain intensity
Time frame: Baseline, at 8 weeks, at 6 month an at one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Long-COVID
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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
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Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stella Fuensalida Novo, PhD principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive neuromodulation in people with Long-COVID and Post-acute COVID-19 Syndrome, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stella Fuensalida Novo, PhD (+34914884865, stella.fuensalida@urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: Baseline, at the of 15th session, at 6 month an at one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.