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Идёт набор NCT07732374

Long-Term Outcomes Following HBOT

Фаза II С лечением Traumatic Brain Injury Post-Concussive Symptoms Post-Traumatic Stress Disorder

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: Traumatic Brain Injury, Post-Concussive Symptoms, Post-Traumatic Stress Disorder. Базовые параметры: от 18 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Assessing Follow-Up Effects Post-Discontinuation of Hyperbaric Oxygen Therapy on Cognitive Function, Mental Health, and Quality of Life in Veterans

Обзор

This study is designed to better understand the long-term effects of hyperbaric oxygen therapy (HBOT). Our goal is to determine whether improvements after treatment are maintained over time and whether additional benefits appear months after treatment has ended. We will evaluate changes in cognitive function, mental health, and daily functioning to help strengthen the scientific evidence supporting the use of HBOT and guide future treatment recommendations.

Подробное описание

This study is designed to evaluate the long-term effects of hyperbaric oxygen therapy (HBOT) following the completion of treatment. While previous research has demonstrated promising improvements, less is known about whether these benefits are sustained over time or whether additional improvements continue to emerge after treatment has ended.

The primary objective of this study is to evaluate the persistence of therapeutic effects following the completion of Hyperbaric Oxygen Therapy (HBOT) in veterans, with a focus on cognitive function and symptom reduction related to PTSD, depression, and anxiety. Follow-up assessments will be conducted 12 weeks post-treatment to determine the durability of these outcomes.

The second objective is to evaluate potential delayed (latency) effects of HBOT on cognitive performance, psychological symptoms (e.g., PTSD, depression, anxiety), and functional status.

The findings of this study will help identify the persistence of treatment effects, characterize the timeline of durability, and strengthen the scientific evidence supporting the long-term use of HBOT for individuals with traumatic brain injury, persistent post-concussive symptoms, and post-traumatic stress disorder.

Вмешательства

  • Препарат Hyperbaric Oxygen Therapy (HBOT)
    Hyperbaric Oxygen Therapy (HBOT): Participants will receive 100% medical oxygen (USP) administered under hyperbaric conditions at 2.0 atmospheres absolute (ATA) for 60 minutes with a scheduled air break over 40 treatment sessions.

Первичные конечные точки

  • NeuroTrax [Срок оценки: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session]
  • PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session]
  • Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session]
  • Generalized Anxiety Disorder 7-item scale (GAD-7) [Срок оценки: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session]
  • World Health Organization Quality of Life (WHOQOL-BREF) [Срок оценки: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session]

Критерии участия

Критерии включения

  • At least 18 years of age.
  • Veteran status
  • Clinically diagnosed with a mTBI, PCS, PTSD, Anxiety, or Depression disorder.
  • Successfully completed the parent Hyperbaric Oxygen Therapy (HBOT) intervention, consisting of the full study treatment protocol (40 HBOT sessions).
  • Willing and able to read, understand, and provide written informed consent for participation in the 12-week follow-up study. Additionally, the Participant has clear consciousness and the ability to express self-feelings independently.
  • Completed cognitive and psychological measurements.
  • Clinical diagnoses cause significant impairment in social or occupational functioning or some other functional capacity.
  • Stability on any current psychoactive medications (antidepressants, anti-anxiety medications, antipsychotics, stimulants, and mood stabilizers).

Критерии исключения

  • Acute medical illness or infection
  • Severe or unstable physical disorders or major cognitive deficits
  • Current manic, psychotic episodes, or serious suicidal ideations
  • Non-English speakers
  • Inability to attend scheduled follow-up visits
  • Significant life events, new neurological injury, or new psychiatric diagnosis or hospitalization occurring after completion of the HBOT intervention that, in the opinion of the investigator, could confound cognitive, psychological, or quality-of-life outcomes.
  • Participation in another interventional clinical study or receipt of a therapeutic intervention following completion of HBOT that could influence cognitive, psychological, or quality-of-life outcomes.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Summit Hyperbarics and Wellness — Boise

Идентификаторы

NCT: NCT07732374 · HBOT-VET-2026-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗