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

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07596641
Acronym
HBOT
Enrollment
1000
Registered
2026-05-19
Start date
2026-12-01
Completion date
2028-03-30
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiorespiratory Fitness, Cognition, Hyperbaric Oxygenation

Keywords

HBOT, VO2MAX, VO2 PEAK, cognitive function, CPET, cardiopulmonary exercise testing, hyperbaric oxygen therapy, HEALTH

Brief summary

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

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

Interventions

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

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Exercise Duration During CPETBaseline 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
Peak Workload During CPETBaseline and post-treatment (approximately 4-6 months)Highest external work rate achieved during CPET on a cycle ergometer. Unit of Measure: Watts (W)
Peak Metabolic Equivalent (METs) During CPETBaseline and post-treatment (approximately 4-6 months)Highest metabolic equivalent level achieved during treadmill-based CPET. Unit of Measure: METs
Ventilatory Threshold Oxygen Uptake (VT1/VT2)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
Ventilatory Threshold WorkloadBaseline and post-treatment (approximately 4-6 months)Workload achieved at ventilatory thresholds (VT1 and VT2) during CPET. Unit of Measure: Watts (W)
Ventilatory Threshold Heart RateBaseline 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)
Time to Ventilatory ThresholdBaseline 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

MeasureTime frameDescription
Change in Cognitive Function Following Hyperbaric Oxygen TherapyBaseline 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.

Contacts

CONTACTEldad Mr Yaakobo, Ms
yaakobi.eldad@gmail.com+972542092860

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026