- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Eldad Mr Yaakobo, Ms
- Telefonnummer: +972542092860
- E-mail: yaakobi.eldad@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Exercise Duration During CPET
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Cognitive Function Following Hyperbaric Oxygen Therapy
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0262-24 ASF
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .