- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07596641
Retrospective Analysis of CPET and Cognitive Tests of Healthy Individuals, Treated With 60 Treatment of HBOT (HBOT)
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Eldad Mr Yaakobo, Ms
- Numer telefonu: +972542092860
- E-mail: yaakobi.eldad@gmail.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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.
|
60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Exercise Duration During CPET
Ramy czasowe: Baseline and post-treatment (approximately 4-6 months)
|
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
Ramy czasowe: Baseline and post-treatment (approximately 4-6 months)
|
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
Ramy czasowe: Baseline and post-treatment (approximately 4-6 months)
|
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)
Ramy czasowe: Baseline and post-treatment (approximately 4-6 months)
|
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
Ramy czasowe: Baseline and post-treatment (approximately 4-6 months)
|
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
Ramy czasowe: Baseline and post-treatment (approximately 4-6 months)
|
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
Ramy czasowe: Baseline and post-treatment (approximately 4-6 months)
|
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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Cognitive Function Following Hyperbaric Oxygen Therapy
Ramy czasowe: Baseline and post-treatment (approximately 4-6 months)
|
Change in standardized cognitive performance scores measured before and after completion of 60 hyperbaric oxygen therapy sessions using NeuroTrax cognitive battery test.
|
Baseline and post-treatment (approximately 4-6 months)
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 0262-24 ASF
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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