Post-Acute COVID-19 SyndromeNCT05793736
Prevention of Long Covid Syndrome
A study testing Biofeedback training and Treatment as usual in people with Post-Acute COVID-19 Syndrome and Biofeedback, Psychology, run by University of Cagliari at 1 site in Italy.
Trial summary
Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical device class II and this type of equipment/treatment has shown evidence regarding stress management in post-Covid-19 syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Acute COVID-19 Syndrome, Biofeedback, Psychology, Quality of Life
- What is being tested?
- Biofeedback training and Treatment as usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2023to 30 Oct 2023
- 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
- People who have contracted Covid-19 and have symptoms attributable to Long syndrome
Who cannot join
- patients with cognitive difficulties and/or diagnosis of mental retardation
- patients with severe comorbidities with the exception of anxious/depression symptoms arising in conjunction with the viral infection or long covid syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of an HVR Protocol Biofeedback Training to Manage Long Covid Syndrome Symptoms
Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical device class II and this type of equipment/treatment has shown evidence regarding stress management in post-Covid-19 syndrome.
The main objective of the study is to verify the feasibility of an HVR biofeedback training protocol in patients with long covid, and also to verify improvement induced by the technique in relation to: cognitive performance; pain perception; fatigue; quality of life; depressive and anxious symptoms
Read the detailed description
Long COVID is known by different names, and include a wide range of persistent symptoms that develop after SARS-CoV-2 infection and last for usually more than 12 weeks to months and up to 2 years, so far. The most common symptoms categorizable as neurological are fatigue, brain fog, and headache, among respiratory symptoms chest pain and shortness of breath, other less easily classifiable symptoms are heart palpitations and muscle pain. These symptoms are often debilitating enough to leave patients unable to work.
According to the WHO (2023), an estimated 17 million people were thought to be living with the long-term effects of COVID-19. Still now in less active pandemic phases, the risk of developing long COVID symptoms, at 10-20% of those infected, remains just as strong.
Trying to find a solution to manage symptoms through evidence-based practices is considered a current necessity to help health patients and professionals.
Biofeedback allows to learn self-regulation of some physiological processes through feedback of recorded parameters and the goal is improving health and its performances.
Biofeedback measures muscle activity, skin temperature, electrodermal activity (sudoriparous glands activity), respiration, heart rate, blood pressure, electrical brain activity and bloodstream, it also gives a quick feedback of those personal measurements to the patient, in this way biofeedback teaches people to have a more active role in maintaining a good personal, mental and physical health (quickly and thoroughly it give person feedback of activity and biofeedback teaches people to take a more active role in maintaining personal health and mental health and physical health).
Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical device class II and this type of equipment/treatment has shown evidence regarding stress management (evidence were shown as regards stress menagement).
The greatest benefits from using biofeedback are: improvement of sleep quality, improvement of self- efficacy, improvement of pain threshold, and improvement of emotional adjustment. In particular, a study conducted with HRV biofeedback, in which the sample learned resonance frequency breathing, showed dicreases in depression and pain and improved the person's system functioning.
Study objectives
The main objective of the study is to verify the feasibility of an HVR biofeedback training protocol in patients with Long Covid syndrome, and also to produce a preliminary measurement of the possible improvement induced by the technique in relation to:cognitive performance; pain perception; fatigue; quality of life; depressive and anxious symptoms. This measure will be useful to estimate the expected improvement in future case-control studies. Study design
This is a controlled clinical trial between usual care and biofeedback training plus usual care.
- Conditions
- Post-Acute COVID-19 Syndrome, Biofeedback, Psychology, Quality of Life, Depressive Symptoms, Fatigue, Anxiety
- Being tested
- Biofeedback training, Treatment as usual
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Depression, Fatigue, Anxiety Disorders, Pain, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback trainingDevice
The intervention lasts 5 weeks, twice a week, each session lasts 45 minutes in which HRV (Heart Rate Variability) is detected, through plethysmographic sensors placed on the finger or earlobe during assigned tasks. During tasks that involve progressively more complex phases, they allow the person to receive immediate feedback on the video screen.
The sample will be treated only with standard therapies (treatment as usual) without the use of biofeedback training
| Study group | Role | What they receive |
|---|---|---|
| biofeedback + treatment as usual | Experimental | The selected sample (n 10) will undergo 10 total Biofeedback Training sessions, twice a week. Each session will last 45 minutes. The total duration of the treatment will be 5 weeks, plus standard therapies (treatment as usual) Receives: Device: Biofeedback training |
| treatment as usual | Active comparator | The control sample (n 10) will be treated only with standard therapies (treatment as usual) without the use of biofeedback training Receives: Drug: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to 5 weeks and to 9 weeks in Patient Health Questionnaire-9 (PHQ-9) score
short self-administered tool used for screening, diagnosis, monitoring and measuring the severity of depression. It's composed of 9 items that correspond to the symptoms of major depression according to DSM-IV. The score has a range between 0 and 27. Scores between 0 and 9 indicate the presence of a sub-threshold depression. The score of 10 is indicated as the point at which the sensitivity and specificity of the instrument are recognized as optimal for highlighting depressions of clinical relevance
Measured: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Change from Baseline to 5 weeks and to 9 weeks in Brief Fatigue Inventory (BFI) score
The Brief Fatigue Inventory (BFI) is a brief screening tool designed to assess the severity and impact of fatigue on daily functioning.
Measured: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Change from Baseline to 5 weeks and to 9 weeks in Short Form Health Survey (SF-12) score
The Short Form Health Survey (SF-12), brief version of SF-36 questionnaire, made up of twelve questions, includes the following dimensions: physical activity, disturbance in physical health, physical condition, self-assessment of health status, vitality, social activity and mental health. Higher SF-12 scores recorded a greeting and QoL performance.
Measured: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Change from Baseline to 5 weeks and to 9 weeks in Matrix test (Spinnler H, Tognoni G., 1987) score
Evaluates the indicators of selective attention
Measured: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Change from Baseline to 5 weeks and to 9 weeks in Trail Making Test (Giovagnoli et al.,1996) score
Evaluates cognitive functions such as cognitive flexibility and inhibitory control and attention
Measured: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Change from Baseline to 5 weeks and to 9 weeks in Digit Span (Orsini et al., 1987; Mondini et al., 2003) score
Evaluate verbal short-term memory and working memory
Measured: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Change from Baseline to 5 weeks and to 9 weeks in Stroop Test (Caffarra et al.; 2002) score
Evaluates selective attention, the processes of inhibition of irrelevant information and cognitive flexibility
Measured: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Change from Baseline to 5 weeks and to 9 weeks in Frontal Assessment Battery - FAB (Dubois et al.; 2000) score
It is a functionality screening battery global executive performance by means of a series of cognitive and behavioral tests
Measured: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Change from Baseline to 5 weeks and to 9 weeks in Rey's Word Test (Caltagirone et al. 1995) score
Evaluates long-term memory, semantic memory, specifies in which phase of the mnemonic process the deficit is
Measured: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Change in Checklist on tolerability, possible side effects after the biofeedback session
Checklist on tolerability, possible side effects after the biofeedback session
Measured: At the end of each biofeedback session
Intervention satisfaction questionnaire
Intervention satisfaction questionnaire
Measured: T1 (5weeks)
Change from Baseline to 5 weeks and to 9 weeks in Visual Analog Scale VAS (Scott Huskisson, 1976) score
Allows you to have a visual representation of the amplitude of the pain perceived by the person ache
Measured: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Change from Baseline to 5 weeks and to 9 weeks in Self-Rating Anxiety Scale (SAS) score
SAS is a 20-item self-report assessment device built to measure anxiety levels, based on scoring in 4 groups of manifestations: cognitive, autonomic, motor and central nervous system symptoms.
Measured: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start2 Feb 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Acute COVID-19 SyndromeStudies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a controlled clinical feasibility trial with three evaluation times (T0 pre-treatment; T1 post treatment five weeks after T0; T2 nine weeks after T1) aimed at verifying the feasibility and tolerability of an intervention performed with biofeedback training (already extensively tested on other clinical populations and free of side effects) and aimed to obtain a preliminary measure of its effectiveness on patients with Long Covid syndrome
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulia Cossu, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793736
- Sponsor's protocol ID
- NP/2023/496
- Status last verified
- May 2024
- First submitted
- 21 Mar 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of an HVR Protocol Biofeedback Training to Manage Long Covid Syndrome Symptoms
- ClinicalTrials.gov ID
- NCT05793736
- Acronym / sponsor ID
- NP/2023/496
- Conditions
- Post-Acute COVID-19 Syndrome, Biofeedback, Psychology, Quality of Life, Depressive Symptoms, Fatigue, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 31 Mar 2023 (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.
Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical device class II and this type of equipment/treatment has shown evidence regarding stress management in post-Covid-19 syndrome.
The main objective of the study is to verify the feasibility of an HVR biofeedback training protocol in patients with long covid, and also to verify improvement induced by the technique in relation to: cognitive performance; pain perception; fatigue; quality of life; depressive and anxious symptoms
Detailed description
Long COVID is known by different names, and include a wide range of persistent symptoms that develop after SARS-CoV-2 infection and last for usually more than 12 weeks to months and up to 2 years, so far. The most common symptoms categorizable as neurological are fatigue, brain fog, and headache, among respiratory symptoms chest pain and shortness of breath, other less easily classifiable symptoms are heart palpitations and muscle pain. These symptoms are often debilitating enough to leave patients unable to work.
According to the WHO (2023), an estimated 17 million people were thought to be living with the long-term effects of COVID-19. Still now in less active pandemic phases, the risk of developing long COVID symptoms, at 10-20% of those infected, remains just as strong.
Trying to find a solution to manage symptoms through evidence-based practices is considered a current necessity to help health patients and professionals.
Biofeedback allows to learn self-regulation of some physiological processes through feedback of recorded parameters and the goal is improving health and its performances.
Biofeedback measures muscle activity, skin temperature, electrodermal activity (sudoriparous glands activity), respiration, heart rate, blood pressure, electrical brain activity and bloodstream, it also gives a quick feedback of those personal measurements to the patient, in this way biofeedback teaches people to have a more active role in maintaining a good personal, mental and physical health (quickly and thoroughly it give person feedback of activity and biofeedback teaches people to take a more active role in maintaining personal health and mental health and physical health).
Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical device class II and this type of equipment/treatment has shown evidence regarding stress management (evidence were shown as regards stress menagement).
The greatest benefits from using biofeedback are: improvement of sleep quality, improvement of self- efficacy, improvement of pain threshold, and improvement of emotional adjustment. In particular, a study conducted with HRV biofeedback, in which the sample learned resonance frequency breathing, showed dicreases in depression and pain and improved the person's system functioning.
Study objectives
The main objective of the study is to verify the feasibility of an HVR biofeedback training protocol in patients with Long Covid syndrome, and also to produce a preliminary measurement of the possible improvement induced by the technique in relation to:cognitive performance; pain perception; fatigue; quality of life; depressive and anxious symptoms. This measure will be useful to estimate the expected improvement in future case-control studies. Study design
This is a controlled clinical trial between usual care and biofeedback training plus usual care.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a controlled clinical feasibility trial with three evaluation times (T0 pre-treatment; T1 post treatment five weeks after T0; T2 nine weeks after T1) aimed at verifying the feasibility and tolerability of an intervention performed with biofeedback training (already extensively tested on other clinical populations and free of side effects) and aimed to obtain a preliminary measure of its effectiveness on patients with Long Covid syndrome
| Arm | Type | Receives |
|---|---|---|
| biofeedback + treatment as usual | Experimental | Device: Biofeedback trainingThe selected sample (n 10) will undergo 10 total Biofeedback Training sessions, twice a week. Each session will last 45 minutes. The total duration of the treatment will be 5 weeks, plus standard therapies (treatment as usual) |
| treatment as usual | Active comparator | Drug: Treatment as usualThe control sample (n 10) will be treated only with standard therapies (treatment as usual) without the use of biofeedback training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People who have contracted Covid-19 and have symptoms attributable to Long syndrome
Key exclusion criteria (2 listed)
- patients with cognitive difficulties and/or diagnosis of mental retardation
- patients with severe comorbidities with the exception of anxious/depression symptoms arising in conjunction with the viral infection or long covid syndrome.
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 |
|---|---|---|
| Biofeedback trainingThe intervention lasts 5 weeks, twice a week, each session lasts 45 minutes in which HRV (Heart Rate Variability) is detected, through plethysmographic sensors placed on the finger or earlobe during assigned tasks. During tasks that involve progressively more complex phases, they allow the person to receive immediate feedback on the video screen. | Device | biofeedback + treatment as usual |
| Treatment as usualThe sample will be treated only with standard therapies (treatment as usual) without the use of biofeedback training | Drug | treatment as usual |
Primary outcome
Change from Baseline to 5 weeks and to 9 weeks in Patient Health Questionnaire-9 (PHQ-9) score
Time frame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
short self-administered tool used for screening, diagnosis, monitoring and measuring the severity of depression. It's composed of 9 items that correspond to the symptoms of major depression according to DSM-IV. The score has a range between 0 and 27. Scores between 0 and 9 indicate the presence of a sub-threshold depression. The score of 10 is indicated as the point at which the sensitivity and specificity of the instrument are recognized as optimal for highlighting depressions of clinical relevance
Change from Baseline to 5 weeks and to 9 weeks in Brief Fatigue Inventory (BFI) score
Time frame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
The Brief Fatigue Inventory (BFI) is a brief screening tool designed to assess the severity and impact of fatigue on daily functioning.
Change from Baseline to 5 weeks and to 9 weeks in Short Form Health Survey (SF-12) score
Time frame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
The Short Form Health Survey (SF-12), brief version of SF-36 questionnaire, made up of twelve questions, includes the following dimensions: physical activity, disturbance in physical health, physical condition, self-assessment of health status, vitality, social activity and mental health. Higher SF-12 scores recorded a greeting and QoL performance.
Change from Baseline to 5 weeks and to 9 weeks in Matrix test (Spinnler H, Tognoni G., 1987) score
Time frame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Evaluates the indicators of selective attention
Change from Baseline to 5 weeks and to 9 weeks in Trail Making Test (Giovagnoli et al.,1996) score
Time frame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Evaluates cognitive functions such as cognitive flexibility and inhibitory control and attention
Change from Baseline to 5 weeks and to 9 weeks in Digit Span (Orsini et al., 1987; Mondini et al., 2003) score
Time frame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Evaluate verbal short-term memory and working memory
Change from Baseline to 5 weeks and to 9 weeks in Stroop Test (Caffarra et al.; 2002) score
Time frame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Evaluates selective attention, the processes of inhibition of irrelevant information and cognitive flexibility
Change from Baseline to 5 weeks and to 9 weeks in Frontal Assessment Battery - FAB (Dubois et al.; 2000) score
Time frame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
It is a functionality screening battery global executive performance by means of a series of cognitive and behavioral tests
Change from Baseline to 5 weeks and to 9 weeks in Rey's Word Test (Caltagirone et al. 1995) score
Time frame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Evaluates long-term memory, semantic memory, specifies in which phase of the mnemonic process the deficit is
Change in Checklist on tolerability, possible side effects after the biofeedback session
Time frame: At the end of each biofeedback session
Checklist on tolerability, possible side effects after the biofeedback session
Intervention satisfaction questionnaire
Time frame: T1 (5weeks)
Intervention satisfaction questionnaire
Change from Baseline to 5 weeks and to 9 weeks in Visual Analog Scale VAS (Scott Huskisson, 1976) score
Time frame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Allows you to have a visual representation of the amplitude of the pain perceived by the person ache
Change from Baseline to 5 weeks and to 9 weeks in Self-Rating Anxiety Scale (SAS) score
Time frame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
SAS is a 20-item self-report assessment device built to measure anxiety levels, based on scoring in 4 groups of manifestations: cognitive, autonomic, motor and central nervous system symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback training and Treatment as usual in people with Post-Acute COVID-19 Syndrome and Biofeedback, Psychology, run by University of Cagliari at 1 site in Italy.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 13 May 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 Italy. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to 5 weeks and to 9 weeks in Patient Health Questionnaire-9 (PHQ-9) score (time frame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)). The study lists 13 primary outcomes in all. 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 May 2024.