CompletedNot Applicable

Prevention of Long Covid Syndrome

Italy17 participantsStarted 2023-02-02

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * People who have contracted Covid-19 and have symptoms attributable to Long syndrome Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline to 5 weeks and to 9 weeks in Patient Health Questionnaire-9 (PHQ-9) score

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

Change from Baseline to 5 weeks and to 9 weeks in Brief Fatigue Inventory (BFI) score

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

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

Trial details

NCT IDNCT05793736

SponsorUniversity of Cagliari

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-30

View on ClinicalTrials.gov More Post-Acute COVID-19 Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from Baseline to 5 weeks and to 9 weeks in Patient Health Questionnaire-9 (PHQ-9) score

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

Change from Baseline to 5 weeks and to 9 weeks in Brief Fatigue Inventory (BFI) score

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

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