An Alternative Way To Deliver Oxygen To People

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2024-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Hypoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Open label

Study Groups

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Low Oxygen Visits without Respirogen Micro-Oxygen

During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures.

Group Type NO_INTERVENTION

No interventions assigned to this group

Low Oxygen Visits with Respirogen Micro-Oxygen

During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures.

Group Type EXPERIMENTAL

Respirogen Micro-Oxygen

Intervention Type DRUG

Enteral (rectal) delivery of Respirogen Micro-Oxygen

Interventions

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Respirogen Micro-Oxygen

Enteral (rectal) delivery of Respirogen Micro-Oxygen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age between 18-40 years,
* body mass index between 19 and 30 kg/m\^2,
* resident at a similar altitude for a minimum of 1-year,
* no travel to/from areas varying by \~2000 feet of elevation within 4-weeks of initiation of study participation.

Exclusion Criteria

* identification of overt chronic disease (including cardio-pulmonary disorders),
* prior diagnosis of asthma, cystic fibrosis, Chronic obstructive pulmonary disease, or ventilator therapy
* anemia,
* pregnancy,
* habitual use of tobacco/nicotine products,
* known allergy to sodium phosphate (or other common laxatives),
* habitual use of recreational drugs that require inhalation,
* history of seizures, kidney problems, stomach or bowel problems, ulcerative colitis, problems with swallowing or gastric reflux, gout, and and/or low blood sodium.
* irritable bowel
* ACUTE respiratory illness such as bronchitis, pneumonia, Upper Respiratory Infection OR ACUTE GI issues such as gastroenteritis.
* Anemia (as measurement of hemoglobin and/or hematocrit) .
* sickle cell disease.
* history of altitude sickness

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes