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

NCT07596641 | Not Yet Recruiting

• 1 other identifier: 0262-24 ASF
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cardiorespiratory Fitness; Hyperbaric Oxygenation; Cognition

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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

  Baseline and post-treatment (approximately 4-6 months)

• Peak Workload During CPET

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

  Baseline and post-treatment (approximately 4-6 months)

• Peak Metabolic Equivalent (METs) During CPET

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

  Baseline and post-treatment (approximately 4-6 months)

• 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

  Baseline and post-treatment (approximately 4-6 months)

• Ventilatory Threshold Workload

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

  Baseline and post-treatment (approximately 4-6 months)

• Ventilatory Threshold Heart Rate

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

  Baseline and post-treatment (approximately 4-6 months)

• Time to Ventilatory Threshold

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

  Baseline and post-treatment (approximately 4-6 months)

Secondary Outcomes (1)

• Change in Cognitive Function Following Hyperbaric Oxygen Therapy

  Baseline and post-treatment (approximately 4-6 months)

Study Arms (1)

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

Hyperbaric Oxygen Therapy - HBOT OTHER

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

Adults Treated With HBOT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Central Study Contacts

Eldad Mr Yaakobo, Ms

CONTACT

+972542092860; yaakobi.eldad@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share