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Not yet recruitingNCT07596641HBOTUpdated May 19, 2026

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

An observational study in Hyperbaric Oxygenation, Cardiorespiratory Fitness and Cognition, sponsored by Assaf-Harofeh Medical Center. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by Assaf-Harofeh Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years to 65 Years
Sex
All
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Study 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

Read the 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

02

Conditions studied

  • Hyperbaric Oxygenation
  • Cardiorespiratory Fitness
  • Cognition

Keywords

  • HBOT
  • VO2MAX
  • VO2 PEAK
  • cognitive function
  • CPET
  • cardiopulmonary exercise testing
  • hyperbaric oxygen therapy
  • HEALTH
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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherHyperbaric Oxygen Therapy - HBOT

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

05

What researchers measure

Primary outcomes

  1. Exercise Duration During CPET

    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

    Time frame: Baseline and post-treatment (approximately 4-6 months)

  2. Peak Workload During CPET

    Highest external work rate achieved during CPET on a cycle ergometer. Unit of Measure: Watts (W)

    Time frame: Baseline and post-treatment (approximately 4-6 months)

  3. Peak Metabolic Equivalent (METs) During CPET

    Highest metabolic equivalent level achieved during treadmill-based CPET. Unit of Measure: METs

    Time frame: Baseline and post-treatment (approximately 4-6 months)

  4. Ventilatory Threshold Oxygen Uptake (VT1/VT2)

    Oxygen uptake measured at ventilatory thresholds (VT1 and VT2) during CPET, reflecting metabolic transition during exercise. Unit of Measure: mL/kg/min

    Time frame: Baseline and post-treatment (approximately 4-6 months)

  5. Ventilatory Threshold Workload

    Workload achieved at ventilatory thresholds (VT1 and VT2) during CPET. Unit of Measure: Watts (W)

    Time frame: Baseline and post-treatment (approximately 4-6 months)

  6. Ventilatory Threshold Heart Rate

    Heart rate recorded at ventilatory thresholds (VT1 and VT2) during CPET. Unit of Measure: Beats per minute (bpm)

    Time frame: Baseline and post-treatment (approximately 4-6 months)

  7. Time to Ventilatory Threshold

    Elapsed exercise time at which ventilatory thresholds (VT1 and VT2) are reached during CPET. Unit of Measure: Minutes

    Time frame: Baseline and post-treatment (approximately 4-6 months)

Secondary outcomes

  1. Change in Cognitive Function Following Hyperbaric Oxygen Therapy

    Change in standardized cognitive performance scores measured before and after completion of 60 hyperbaric oxygen therapy sessions using NeuroTrax cognitive battery test.

    Time frame: Baseline and post-treatment (approximately 4-6 months)

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07596641
Lead sponsor
Assaf-Harofeh Medical Center
Responsible party
Sponsor
First posted
May 19, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Mar 30, 2028 (estimated)
Last update
May 19, 2026

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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