Clinical Trials

Clinical Trial – Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism

The purpose of this study is to increase the understanding of the effect of Hyperbaric Oxygen
Treatment (HBOT) on the behavior and functioning of children with autism. The main goal of
this study is to demonstrate that HBOT is safe and tolerable in autistic children, and to
measure the effect of HBOT on specific chemicals in their blood that may play a role in the
child’s behavior.

Clinical Trial – Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy

The purpose of this study is to determine whether spinal anesthesia combined with intrathecal
morphine in abdominal hysterectomy on benign gynecological indications gives better outcome
concerning duration of hospital stay and postoperative patient comfort than general
anesthesia.

Clinical Trial – Effects of Mild Hypobaric Hypoxia on Sleep and Post-sleep Performance

Hypobaric hypoxia (decreased oxygen supply to body tissues due to low atmospheric pressure)
caused by exposure to high altitude disrupts sleep. Sleep deprivation is associated with
degraded post-sleep performance of neurobehavioral tasks. The lowest altitude at which sleep
and/or post-sleep performance are affected is not known. The study hypothesis is that sleep
and/or post-sleep performance of neurobehavioral tasks will occur due to hypobaric hypoxia at
altitudes of 8,000 or less.

Clinical Trial – Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities

The primary purpose of this study is to assess whether hyperbaric oxygen treatment improves
neurological function in patients who exhibit white matter hyperintensities on MRI
examination.

The secondary goal of this study is to determine if it is possible using MRI to discern a
difference in perfusion of central nervous system tissue in regions of white matter
hyperintensities after hyperbaric oxygen administration as compared to hyperbaric air.

Clinical Trial – Dose Escalation Study of Hyperbaric Oxygen With Radiation and Chemotherapy to Treat Squamous Cell Carcinoma of the Head and Neck

This research is being done because we do not know the best treatment for advanced Squamous
Cell Carcinoma of the Head and Neck. These cancers have been treated with a combination of
surgery, radiation and chemotherapy in varying combination. When the tumor is inoperable,
radiation therapy is used with or without chemotherapy in the hope of curing the tumor.

Recently, it has become recognized as generalized knowledge that cancer cells are hypoxic
(low oxygen concentration). Because of the low oxygen concentrations, many cancer treatments
have not been successful. The theory behind this study is to give oxygen to patients prior to
chemotherapy and radiation in hopes of generating greater results in killing cancer cells.
The purpose of this study has two main objectives. The primary objective is to determine
patient tolerance to each arm of the trial.

The second objective is to determine the feasibility of treatment delivery and acute
toxicities associated with each regimen.

It is our intention to undertake a randomized and controlled trial should this Phase I trial
prove successful in terms of patient tolerance.

Clinical Trial – Hyperbaric Oxygen Therapy and Angiogenesis in Diabetic Patients With Foot Ulcers

Diabetic foot ulcers are a major cause of morbidity and mortality, accounting for
approximately two-thirds of all non-traumatic amputations performed in the United States. The
cost of foot ulcers in diabetic patients averages almost $28,000 for the two years after
diagnosis of the ulcer. Hyperbaric oxygen (HBO) serves as primary or adjunctive therapy for a
diverse range of medical conditions. HBO also has been used as an adjunct to antibiotics,
debridement, and revascularization in the therapy of chronic, nonhealing wounds associated
with diabetes or non-diabetic vascular insufficiency.

The aim of the study is to assess whether hyperoxia induced angiogenesis in diabetic patients
with foot ulcers.

Archives

Categories