Retrospective Analysis of CPET and Cognitive Tests of Healthy Individuals, Treated With 60 Treatment of HBOT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperbaric Oxygen Therapy - HBOT.
- Who it may be relevant to
- Registry conditions: Hyperbaric Oxygenation, Cardiorespiratory Fitness, Cognition. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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
- Other Hyperbaric Oxygen Therapy - HBOT
60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period
Primary outcome measures
- Exercise Duration During CPET [Time frame: Baseline and post-treatment (approximately 4-6 months)]
- Peak Workload During CPET [Time frame: Baseline and post-treatment (approximately 4-6 months)]
- Peak Metabolic Equivalent (METs) During CPET [Time frame: Baseline and post-treatment (approximately 4-6 months)]
- Ventilatory Threshold Oxygen Uptake (VT1/VT2) [Time frame: Baseline and post-treatment (approximately 4-6 months)]
- Ventilatory Threshold Workload [Time frame: Baseline and post-treatment (approximately 4-6 months)]
- Ventilatory Threshold Heart Rate [Time frame: Baseline and post-treatment (approximately 4-6 months)]
- Time to Ventilatory Threshold [Time frame: Baseline and post-treatment (approximately 4-6 months)]
Secondary outcome measures (1)
- Change in Cognitive Function Following Hyperbaric Oxygen Therapy [Time frame: Baseline and post-treatment (approximately 4-6 months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07596641 · 0262-24 ASF