Retrospective Analysis of CPET and Cognitive Tests of Healthy Individuals, Treated With 60 Treatment of HBOT
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorAssaf-Harofeh Medical Center
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Hyperbaric Oxygen Therapy - HBOT
Other intervention60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Adults Treated With HBOT1 intervention
Trial outcomes
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)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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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