Retrospective Analysis of CPET and Cognitive Tests of Healthy Individuals, Treated With 60 Treatment of HBOT (HBOT)

May 17, 2026 updated by: Assaf-Harofeh Medical Center

Retrospective Analysis of Cardiopulmonary Exercise Tests and Cognitive Tests of Healthy Individuals Age 18+ Years, Treated at the Sagol Center for Hyperbaric Medicine and Research With 60 Hyperbaric Oxygen Therapy Treatments.

This retrospective observational study evaluates physiological and cognitive changes following a series of 60 hyperbaric oxygen therapy (HBOT) sessions in healthy individuals. Participants underwent treatment five days per week, each session included 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air break every 20 minutes. Pre- and post-treatment data include cardiopulmonary exercise testing (CPET) and standardized cognitive assessments. The study aims to characterize associations between changes in cardiorespiratory fitness and cognitive performance following repeated HBOT exposure in a real-world clinical cohort

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This retrospective observational study analyzes data collected from healthy adults who completed a full treatment series of 60 hyperbaric oxygen therapy (HBOT) sessions at the Sagol Center for Hyperbaric Medicine and Research. Each session included 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air break every 20 minutes

The primary objective is to evaluate physiological adaptations to repeated HBOT exposure using cardiopulmonary exercise testing (CPET) metrics, including aerobic capacity and exercise performance parameters. A secondary objective is to examine concurrent changes in cognitive function as assessed by standardized neurocognitive testing performed as part of routine clinical evaluation.

The study utilizes de-identified data extracted from clinical records and institutional databases. As a retrospective analysis, no intervention or allocation was performed for research purposes. The study aims to explore potential relationships between changes in physical performance and cognitive outcomes following HBOT in in a real-world clinical cohort

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This retrospective cohort includes adults treated at the Sagol Center who completed a full course of 60 hyperbaric oxygen therapy sessions. All participants underwent pre- and post-treatment cardiopulmonary exercise testing and standardized cognitive evaluations as part of routine clinical care. Data were extracted from institutional clinical databases for retrospective analysis.

Description

Inclusion Criteria:

  • Adults aged 18-65 years
  • Completed a full treatment series of 60 hyperbaric oxygen therapy (HBOT) sessions at the Sagol Center
  • Availability of pre- and post-treatment cardiopulmonary exercise testing (CPET) data
  • Availability of pre- and post-treatment cognitive assessment data

Exclusion Criteria:

  • Inability to complete a maximal CPET test, pre and post HBOT or Missing pre- or post-treatment CPET data.
  • Incomplete HBOT treatment series
  • Missing cognitive assessment data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults Treated With HBOT
Retrospective cohort of adults who completed a full treatment series of 60 hyperbaric oxygen therapy (HBOT) sessions at 2 atmospheres absolute (ATA) breathing 100% oxygen, and were approved for a maximal cardiopulmonary exercise testing (CPET). Prticipants underwent pre- and post-treatment cardiopulmonary exercise testing (CPET) and cognitive assessments as part of routine clinical evaluation.
Other: Hyperbaric Oxygen Therapy - HBOT
60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Duration During CPET
Time Frame: Baseline and post-treatment (approximately 4-6 months)

Total duration the participant is able to continue the cardiopulmonary exercise testing (CPET) protocol until voluntary exhaustion or termination criteria are reached.

Unit of Measure: Minutes
Baseline and post-treatment (approximately 4-6 months)
Peak Workload During CPET
Time Frame: Baseline and post-treatment (approximately 4-6 months)

Highest external work rate achieved during CPET on a cycle ergometer.

Unit of Measure: Watts (W)
Baseline and post-treatment (approximately 4-6 months)
Peak Metabolic Equivalent (METs) During CPET
Time Frame: Baseline and post-treatment (approximately 4-6 months)

Highest metabolic equivalent level achieved during treadmill-based CPET.

Unit of Measure: METs
Baseline and post-treatment (approximately 4-6 months)
Ventilatory Threshold Oxygen Uptake (VT1/VT2)
Time Frame: Baseline and post-treatment (approximately 4-6 months)
Oxygen uptake measured at ventilatory thresholds (VT1 and VT2) during CPET, reflecting metabolic transition during exercise. Unit of Measure: mL/kg/min
Baseline and post-treatment (approximately 4-6 months)
Ventilatory Threshold Workload
Time Frame: Baseline and post-treatment (approximately 4-6 months)

Workload achieved at ventilatory thresholds (VT1 and VT2) during CPET.

Unit of Measure: Watts (W)
Baseline and post-treatment (approximately 4-6 months)
Ventilatory Threshold Heart Rate
Time Frame: Baseline and post-treatment (approximately 4-6 months)
Heart rate recorded at ventilatory thresholds (VT1 and VT2) during CPET. Unit of Measure: Beats per minute (bpm)
Baseline and post-treatment (approximately 4-6 months)
Time to Ventilatory Threshold
Time Frame: Baseline and post-treatment (approximately 4-6 months)
Elapsed exercise time at which ventilatory thresholds (VT1 and VT2) are reached during CPET. Unit of Measure: Minutes
Baseline and post-treatment (approximately 4-6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognitive Function Following Hyperbaric Oxygen Therapy
Time Frame: Baseline and post-treatment (approximately 4-6 months)
Change in standardized cognitive performance scores measured before and after completion of 60 hyperbaric oxygen therapy sessions using NeuroTrax cognitive battery test.
Baseline and post-treatment (approximately 4-6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 30, 2028

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0262-24 ASF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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