Prevention of Long Covid Syndrome

NCT05793736 | Completed FDA Device

• 1 other identifier: NP/2023/496
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Post-Acute COVID-19 Syndrome; Biofeedback, Psychology; Quality of Life; Depressive Symptoms; Fatigue; Anxiety; Pain; Cognitive Symptom

Outcome Measures

Primary Outcomes (13)

• 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

  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.

  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.

  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

  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

  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

  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

  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

  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

  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

  At the end of each biofeedback session

• Intervention satisfaction questionnaire

  Intervention satisfaction questionnaire

  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

  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.

  T0 (0 weeks); T1 (5weeks); T2 (9 weeks)

Study Arms (2)

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)

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

Drug: Treatment as usual

Interventions

Biofeedback training DEVICE

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.

biofeedback + treatment as usual

Treatment as usual DRUG

The sample will be treated only with standard therapies (treatment as usual) without the use of biofeedback training

treatment as usual

Eligibility Criteria

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

You may qualify if:

• People who have contracted Covid-19 and have symptoms attributable to Long syndrome

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

P.O. San Giovanni di Dio, AOU Cagliari

Cagliari, 09100, Italy

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Depression; Fatigue; Anxiety Disorders; Pain; Neurobehavioral Manifestations

Interventions

Therapeutics

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; Behavioral Symptoms; Behavior; Signs and Symptoms; Mental Disorders; Neurologic Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: March 31, 2023
• Study Start: February 2, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

IT (1)