- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Eldad Mr Yaakobo, Ms
- Número de teléfono: +972542092860
- Correo electrónico: yaakobi.eldad@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
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60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Exercise Duration During CPET
Periodo de tiempo: Baseline and post-treatment (approximately 4-6 months)
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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)
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Peak Workload During CPET
Periodo de tiempo: Baseline and post-treatment (approximately 4-6 months)
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Highest external work rate achieved during CPET on a cycle ergometer. Unit of Measure: Watts (W) |
Baseline and post-treatment (approximately 4-6 months)
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Peak Metabolic Equivalent (METs) During CPET
Periodo de tiempo: Baseline and post-treatment (approximately 4-6 months)
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Highest metabolic equivalent level achieved during treadmill-based CPET. Unit of Measure: METs |
Baseline and post-treatment (approximately 4-6 months)
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Ventilatory Threshold Oxygen Uptake (VT1/VT2)
Periodo de tiempo: Baseline and post-treatment (approximately 4-6 months)
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Oxygen uptake measured at ventilatory thresholds (VT1 and VT2) during CPET, reflecting metabolic transition during exercise.
Unit of Measure: mL/kg/min
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Baseline and post-treatment (approximately 4-6 months)
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Ventilatory Threshold Workload
Periodo de tiempo: Baseline and post-treatment (approximately 4-6 months)
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Workload achieved at ventilatory thresholds (VT1 and VT2) during CPET. Unit of Measure: Watts (W) |
Baseline and post-treatment (approximately 4-6 months)
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Ventilatory Threshold Heart Rate
Periodo de tiempo: Baseline and post-treatment (approximately 4-6 months)
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Heart rate recorded at ventilatory thresholds (VT1 and VT2) during CPET.
Unit of Measure: Beats per minute (bpm)
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Baseline and post-treatment (approximately 4-6 months)
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Time to Ventilatory Threshold
Periodo de tiempo: Baseline and post-treatment (approximately 4-6 months)
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Elapsed exercise time at which ventilatory thresholds (VT1 and VT2) are reached during CPET.
Unit of Measure: Minutes
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Baseline and post-treatment (approximately 4-6 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Cognitive Function Following Hyperbaric Oxygen Therapy
Periodo de tiempo: Baseline and post-treatment (approximately 4-6 months)
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Change in standardized cognitive performance scores measured before and after completion of 60 hyperbaric oxygen therapy sessions using NeuroTrax cognitive battery test.
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Baseline and post-treatment (approximately 4-6 months)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0262-24 ASF
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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