Pilot Open Label Use of the Hi-OXSR for the Treatment of... | NCT06379620

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

NCT06379620

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Apr 25, 2024Actual

Enrollment

37Actual

Phase

Phase 1

Conditions

Post COVID-19 Condition

Interventions

Hi-OxSR Sequential Rebreathing mask (oxygen concentrator)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 29, 2022Actual

Primary Completion Date

Mar 4, 2024Actual

Completion Date

Mar 4, 2024Actual

First Submitted Date

Apr 22, 2024

First Submission Date that Met QC Criteria

Apr 22, 2024

First Posted Date

Apr 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2024

Last Update Posted Date

Apr 25, 2024Actual

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hi-OXSR group	Experimental	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.	Device: Hi-OxSR Sequential Rebreathing mask (oxygen concentrator)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hi-OxSR Sequential Rebreathing mask (oxygen concentrator)	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

Measure	Description	Time Frame
Safety of use of Hi-OX sequential rebreathing device	Any unanticipated adverse events reporting	45 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

History of cognitive dysfunction prior to COVID infection
Hospitalization for the treatment of COVID
Participating in another investigational trial or the use of an investigational drug within 30 days of screening
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)
History of pulmonary hypertension
History of narcolepsy
Moderate to severe COPD
Interstitial Pulmonary Fibrosis
End-tidal PCO2 >55 mmHg during training treatment
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Angela Cheung, Md, PhD	University Health Network, Toronto	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University Health Network		Toronto	Ontario	M5G 2C4	Canada

ID	Term
D060825	Cognitive Dysfunction
D000094024	Post-Acute COVID-19 Syndrome

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D000086382	COVID-19

Intervention Model Description

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.