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NCT05228665: HEARTLOC
HEART Rate Variability Biofeedback in LOng COVID-19 (HEARTLOC)
NA trial testing Heart Rate Variability Biofeedback (HRV-B) in COVID-19 in 30 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | University of Leeds |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 24 January 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 March 2024 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Heart Rate Variability Biofeedback (HRV-B)
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
University of Leeds
Who can join
18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Long COVID is a common but highly debilitating illness which develops after infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID-19). It is thought to affect as many as 1 in 7 people following COVID-19 infection. It can produce a vast array of symptoms including fatigue, breathlessness, fast heart rate, blood pressure disturbance, temperature disturbance, and dry mouth. Many of these symptoms could be explained by the nervous system being predominantly in a stress or 'fight or flight' response, also known as dysautonomia. One way of assessing whether this is the case is by measuring heart rate variability (HRV). This is the time variation between heart beats and is a marker of how stressed the nervous system is or how strong is the 'fight or flight' response. Heart rate variability can be measured using devices which are worn round the wrist or attach to the chest. An increased variability in heart rate corresponds with a more relaxed nervous system and decreased variability with a more stressed nervous system. Monitoring HRV in real-time and implementing interventions such as a breathing regime to maximise HRV is known as HRV biofeedback. The body can be trained out of the fight or flight response and into the 'rest and digest' mode response of the nervous system in this way and potentially significantly improve symptoms. We propose that for people with Long COVID, a programme of structured breathing exercises over 4 weeks whilst tracking HRV can demonstrate an improvement in HRV and consequently improve Long COVID symptoms.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
HEART Rate Variability Biofeedback for LOng COVID Dysautonomia (HEARTLOC): Results of a Feasibility Study.
Corrado J, Iftekhar N, Halpin S, Li M, et al · · 2024 · cited 19× · PMID 38298551 · DOI 10.1177/27536351241227261 -
HEART rate variability biofeedback for long COVID symptoms (HEARTLOC): protocol for a feasibility study.
Corrado J, Halpin S, Preston N, Whiteside D, et al · · 2022 · cited 12× · PMID 36410797 · DOI 10.1136/bmjopen-2022-066044 -
HEART rate variability biofeedback breathing programme for LOng Covid dysautonomia (HEARTLOC): results of a feasibility study
Corrado J, Iftekhar N, Halpin S, Li M, et al · · 2023 · DOI 10.1101/2023.09.09.23295208 -
HEART rate variability biofeedback for LOng Covid symptoms (HEARTLOC): protocol for a feasibility study
Corrado J, Halpin S, Preston N, Whiteside D, et al · · 2022 · DOI 10.1101/2022.06.23.22276821
Verify or expand the search:
- PubMed search for NCT05228665
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05228665 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Leeds
- Last refreshed: 24 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05228665.
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