Pilot Open Label Use of the Hi-OXSR for the Treatment of Post COVID-19 Cognitive Dysfunction

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-29

Study Completion Date

2024-03-04

Brief Summary

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During the worldwide COVID-19 pandemic a large number patients reported different functional complaints one month or later after recovery from the acute infection. This entity had a number of names including "long-COVID" or "post COVID condition". Long-COVID is on the rise and no effective treatment exists yet to improve cognitive function. Recent research has shown that people with even mild COVID had a greater decline in executive function, notably in their ability to perform complex tasks. What drives post-COVID cognitive changes is still a mystery and there are no effective treatments available. One hypothesis is that there is persistent immune activation resulting in reduction in cerebral blood flow. There is evidence that increased CO2 may decrease inflammation, and decreased CO2 may increase inflammation.

Objectives: The primary objective of this pilot study is to assess the safety and tolerability of the use of Hi-OX sequential rebreathing for the treatment of post-COVID cognitive dysfunction. The secondary objective is to identify the effects of the use of the Hi-OX rebreathing treatment in changing post-COVID cognitive dysfunction.

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Detailed Description

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Conditions

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Post COVID-19 Condition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is an open label, pilot treatment study. Screening data will be reviewed to determine subject eligibility. Upon successful completion of all screening procedures, subject will be considered eligible for enrollment.

The subject will self-administer oxygen gas at 1to 3LPM via a Hi-OxSR Sequential Rebreathing mask, twice a day for 30 minutes with ventilation supplemented by the subject's rebreathed exhaled air. Total treatment is for 14 days. Subjects will be asked to return to the clinic for additional evaluations on Days 15 and 45.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hi-OXSR group

Oxygen gas at 1 to 3LPM via a Hi-OxSR Sequential Rebreathing mask (oxygen concentrator), twice a day for 30 minutes with increased inspired CO2 concentration produced by having the subject rebreathe some of their exhaled air. Total treatment is for 14 days.

Group Type EXPERIMENTAL

Hi-OxSR Sequential Rebreathing mask (oxygen concentrator)

Intervention Type DEVICE

Subjects will self-administer oxygen gas at 1to 3LPM via a Hi-OxSR Sequential Rebreathing mask (oxygen concentrator), twice a day for 30 minutes with ventilation supplemented by the subject's rebreathed exhaled air. Total treatment is for 14 days

Interventions

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Hi-OxSR Sequential Rebreathing mask (oxygen concentrator)

Subjects will self-administer oxygen gas at 1to 3LPM via a Hi-OxSR Sequential Rebreathing mask (oxygen concentrator), twice a day for 30 minutes with ventilation supplemented by the subject's rebreathed exhaled air. Total treatment is for 14 days

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Ability to provide written informed consent.
2. Previously diagnosed with cognitive dysfunction following recovery from COVID.
3. Not pregnant at time of study.
4. Oxygen saturation on room air ≥92% at screening.
5. Willing and able to comply with the treatment schedule and procedures.

Exclusion Criteria

1. History of cognitive dysfunction prior to COVID infection
2. Hospitalization for the treatment of COVID
3. Participating in another investigational trial or the use of an investigational drug within 30 days of screening
4. For individuals of childbearing potential:

positive pregnancy test at screening or lactating or unwilling to practice a medically acceptable form of contraception from screening to Day 14 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent)
5. History of pulmonary hypertension
6. History of narcolepsy
7. Moderate to severe COPD
8. Interstitial Pulmonary Fibrosis
9. End-tidal PCO2 \>55 mmHg during training treatment
10. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No