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NCT Number: NCT07596641

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

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

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Key information

Conditions

Hyperbaric Oxygenation Cardiorespiratory Fitness Cognition

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbaric Oxygen Therapy - HBOT

Other

60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period

Primary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eldad Mr Yaakobo, Ms

CONTACT

[email protected]

+972542092860

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Official study title

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.

Acronym: HBOT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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