An Alternative Way To Deliver Oxygen To People

Evaluation of Respirogen Oxygen Microbubble Technology: Efficacy for Human Use During Rest in Normal and Low-oxygen Environments

Status

Withdrawn

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04870801

Enrollment

Registered

2021-05-04

Start date

2022-01-31

Completion date

2024-01-31

Last updated

2022-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia

Brief summary

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.

Interventions

DRUGRespirogen Micro-Oxygen

Enteral (rectal) delivery of Respirogen Micro-Oxygen

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Masking description

Open label

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Increases Oxygen saturation (SpO2) with RMO	Randomized crossover, visits separated by a minimum 7 days and maxim 14 days	Enteral (rectal) delivery of without and with RMO to resting adult men and women during short-term breathing of hypoxic gas mixtures.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026