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Набор скоро начнётся NCT07596641

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

— Наблюдательное Hyperbaric Oxygenation Cardiorespiratory Fitness Cognition

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Hyperbaric Oxygen Therapy - HBOT.
Кому может быть актуально
Состояния в реестре: Hyperbaric Oxygenation, Cardiorespiratory Fitness, Cognition. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Официальное название

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.

Обзор

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

Подробное описание

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

Вмешательства

  • Другое Hyperbaric Oxygen Therapy - HBOT
    60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period

Первичные конечные точки

  • Exercise Duration During CPET [Срок оценки: Baseline and post-treatment (approximately 4-6 months)]
  • Peak Workload During CPET [Срок оценки: Baseline and post-treatment (approximately 4-6 months)]
  • Peak Metabolic Equivalent (METs) During CPET [Срок оценки: Baseline and post-treatment (approximately 4-6 months)]
  • Ventilatory Threshold Oxygen Uptake (VT1/VT2) [Срок оценки: Baseline and post-treatment (approximately 4-6 months)]
  • Ventilatory Threshold Workload [Срок оценки: Baseline and post-treatment (approximately 4-6 months)]
  • Ventilatory Threshold Heart Rate [Срок оценки: Baseline and post-treatment (approximately 4-6 months)]
  • Time to Ventilatory Threshold [Срок оценки: Baseline and post-treatment (approximately 4-6 months)]
Вторичные конечные точки (1)
  • Change in Cognitive Function Following Hyperbaric Oxygen Therapy [Срок оценки: Baseline and post-treatment (approximately 4-6 months)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07596641 · 0262-24 ASF

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗