An interventional study of Hyperbaric oxygen therapy and Diving simulation in Decompression Sickness, sponsored by Direction Centrale du Service de Santé des Armées. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-28.
Sponsored by Direction Centrale du Service de Santé des Armées · Not applicable, Interventional, and Basic science
The impact of oxygen therapy in many pathologies has been subject of recent work, arguing both favourable and harmful effects. Consequently, one can wonder about the influence of hyperoxic gas mixture during diving on the genesis of decompression sickness, but also about the systematic application of normobaric and hyperbaric oxygen in case of proven decompression sickness.
In mammals, normoxic concentrations have been redefined at 20-100 mbars at the extracellular level and below 10 mbars in the mitochondria.
Under hyperbaric conditions, most of the oxygen being dissolved in blood plasma, a state of hyperoxia is established which escapes the usual delivery and regulation system represented by red blood cells.
The results of our team's previous work suggest a specific effect of diving on the levels of circulating mitochondrial DNA (mtDNA), suggesting cellular destruction linked to hyperoxia/hyperbaria. In fact, our studies, carried out on both animals and human divers, have shown that diving accident leads to an increase in mtDNA levels and an immune reaction through the mobilisation of leukocytes.
The main objective of this study is to compare the influence of oxygen partial pressure levels on the evolution of clinical and biological variables during hyperbaric oxygen therapy sessions in healthy versus injured divers.
21 studies on the registry are indexed under Decompression Sickness; 6 are open to participants now.
Browse Decompression Sickness studies →Direction Centrale du Service de Santé des Armées is the lead sponsor of 95 studies on the registry; 33 are open to participants now.
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Procedure: Hyperbaric oxygen therapy · Procedure: Diving simulation
Procedure: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy protocol
Hyperbaric chamber diving simulation protocol
Evolution of decompression sickness clinical symptoms
Decompression sickness clinical symptoms will be assessed through a medical examination after each hyperbaric session. Decompression sickness clinical symptoms include: paresthesia, sensory deficit, motor deficit, spinal pain, sphincter disorder and brain injury. The evolution of symptoms will be rated as following: total regression, improvement, stabilization, fluctuation or worsening
Time frame: Until the end of the oxygen therapy treatment (up to 1 year)
Plan to share: Undecided
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Direction Centrale du Service de Santé des Armées