Quality of Life After Hyperbaric Oxygen Therapy in Post-COVID Patients

NCT06159309 | Active Not Recruiting

• 1 other identifier: MEC-2023-0433
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

Brief Summary

Post-Covid syndrome, also known as long Covid, is a clinical condition in which patients experience long term symptoms after Covid-19 infection. Treatment options for post-Covid are not effective. Therefore, there is an urgent need for a novel therapy. The first study results of HBOT in post-Covid patients are promising. Previous research from Israel has shown improvements in quality of life after HBOT. However, long term results are unknown. Therefore, this study aims to evaluate quality of life at one year after hyperbaric oxygen therapy in post-Covid patients with cognitive symptoms. It is hypothesized that quality of life at one year after HBOT is improved. Furthermore, this study aims to evaluate return to work after HBOT. To our knowledge this was not done before. An observational prospective cohort study will be conducted to answer the research questions. All post-Covid patients who are treated with hyperbaric oxygen therapy in participating centers, will be eligible for inclusion. Questionnaires and medical doctor consultations will be used in order to collect all data. There are no risks for participants, since only 7 questionnaires are not part of standard clinical care. The burden is approximately 40 minutes extra in total for participants, compared to standard clinical care.

Conditions

Long COVID; Long COVID-19 Syndrome; Long Covid19; Long Covid 19

Keywords

registry; covid; long-covid; post-covid

Outcome Measures

Primary Outcomes (1)

• Quality of life 3 and 12 months

  Is the expected improvement in quality of life in Long COVID patients after treatment with HBOT maintained at 12-months follow-up

  3 and 12 months

Secondary Outcomes (5)

• Long Covid symptoms

  3 and 12 months

• Cognitive complaints

  3 and 12 months

• Work

  3 and 12 months

• Risk factors quality of life

  3 and 12 months

• Profile of non-responders versus responders

  3 and 12 months

Study Arms (1)

Long Covid patients

All post-COVID patients that are referred for hyperbaric oxygen (and that are eligible for treatment)

Other: Hyperbaric oxygen therapy

Interventions

Hyperbaric oxygen therapy OTHER

HBOT per local protocol, i.e. 40 sessions 2.4 ATA, at the discretion of the hyperbaric physician

Long Covid patients

Eligibility Criteria

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

Study Population

The population will consist of post-Covid patients from the Netherlands, who are treated with hyperbaric oxygen therapy at several different treatment centers. All patients are adults and will receive standard clinical hyperbaric oxygen therapy at these clinics.

You may qualify if:

• Long COVID patients who are reffered for treatment with hyperbaric oxygen therapy
• Patients are suffering from cognitive symptoms for \>3 months after Covid infection

You may not qualify if:

• Patients who are not able to fill in questionnaires and informed consent.
• Patients who can't read or do not understand the Dutch language

Sponsors & Collaborators

• Rutger Lalieu: lead

Study Sites (6)

DVK Hogeveen

Hoogeveen, Drenthe, 7909 AK, Netherlands

Location

DVK Geldrop

Geldrop, North Brabant, 5664 HB, Netherlands

Location

DVK Waalwijk

Waalwijk, North Brabant, 5141 BM, Netherlands

Location

HGC Rijswijk

Rijswijk, South Holland, 2288EG, Netherlands

Location

DVK Rotterdam

Rotterdam, South Holland, 3081 AA, Netherlands

Location

DVK Amersfoort

Amersfoort, Utrecht, 3813 TZ, Netherlands

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Hyperbaric Oxygenation

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

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 6, 2023
• Study Start: February 6, 2023
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (6)