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The project was denied funding and the protocol was subsequently closed. No participants were enrolled.
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| Name | Class |
|---|---|
| Respirogen Inc. | UNKNOWN |
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The availability of oxygen is a crucial prognostic indicator for outcomes pertinent to many chronic diseases. Accordingly, interventions that might increase oxygen availability have obvious beneficial clinical application. In this regard, Respirogen Micro-Oxygen (RMO) technology holds considerable promise. Data from experimental animal models of lung injury suggest administration of RMO is a feasible method to deliver oxygen in a manner independent of pulmonary function. Our ultimate long-term goal is to provide a product that can be used to deliver oxygen to humans experiencing respiratory distress and pulmonary dysfunction In this first exploratory study, our goal is to begin to understand the physiological responses to enteral (rectal) delivery of RMO in low-oxygen environments in healthy adults at rest.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Oxygen Visits without Respirogen Micro-Oxygen | No Intervention | During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures. | |
| Low Oxygen Visits with Respirogen Micro-Oxygen | Experimental | During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respirogen Micro-Oxygen | Drug | Enteral (rectal) delivery of Respirogen Micro-Oxygen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increases Oxygen saturation (SpO2) with RMO | Enteral (rectal) delivery of without and with RMO to resting adult men and women during short-term breathing of hypoxic gas mixtures. | Randomized crossover, visits separated by a minimum 7 days and maxim 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Bell, PhD | CSU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado State University, Dept. of Health and Exercise Science | Fort Collins | Colorado | 80523-1582 | United States |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Following screening, six healthy adults will report to the Human Performance Clinical Research Laboratory on two separate occasions, each separated by ~7-14 days. During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures. During one of these visits, following initiation of hypoxic gas breathing, colon administration of RMO will commence.
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Open label
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