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Not yet recruiting NCT07596641

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

Observational Hyperbaric Oxygenation Cardiorespiratory Fitness Cognition

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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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗