Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

July 31, 2023 updated by: Nicholas Breitborde
Single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Functional deficits in prefrontal, limbic, and temporal regions of the brain are well-documented among individuals with psychotic disorders. Mitochondrial dysfunction may contribute to such pathology, and effective functioning of mitochondrial activity in the brain in dependent on a sufficient supply of oxygen. These data suggest that oxygen therapy may improve symptoms in individuals with psychosis. This small pilot study will test this hypothesis.

Individuals with first-episode psychosis will be randomized to receive either (i) 4 weeks of nightly normobaric oxygen therapy (40% FiO2) or (ii) 4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2). Participants will be blinded to what condition they receive. Both conditions will be delivered via nasal cannula connected to oxygen concentrators at five liters per minute (lpm), and participants will be instructed to complete the intervention overnight while sleeping. At the end of the 4 week period, all individuals will receive an additional 4 weeks of unblinded (i.e., "open label") nightly normobaric oxygen therapy (40% FiO2). Study assessments will be completed at (i) enrollment; (ii) 4 weeks after enrollment, and (iii) 8 weeks after enrollment.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

  • Diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-5.
  • Less than 5 years since the onset of frank psychotic symptoms as determined using the Symptom Onset in Schizophrenia Inventory .
  • No evidence of a pre-existing intellectual disability defined as a premorbid IQ >70 as estimated using the Reading subtest of the Wide Range Achievement Test-4.
  • Ages 15-35
  • Non-smoker for past six months
  • Absence of suicidal ideation or behavior over the past month as assessed by the Columbia Suicide Severity Rating Scale
  • The American Association for Respiratory Care notes that "no absolute contraindications to oxygen therapy exist when indications [for oxygen therapy] are present."

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normobaric Oxygen Therapy (40% FiO2)
4 weeks of nightly normobaric oxygen therapy (40% FiO2)
Device: Normobaric Oxygen
40% FiO2 for 4 weeks
Placebo Comparator: Placebo Condition
4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2)
Device: Placebo
21% FiO2 for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in cognitive functioning
Time Frame: 4 weeks
Change in scores on the MATRICS Consensus Cognitive Battery (MCCB).
4 weeks
Change from baseline in quality of life
Time Frame: 4 weeks
Change in scores on WHO Quality of Life Scale Brief (WHOQOL-BREF.
4 weeks
Change from baseline in social functioning
Time Frame: 4 weeks
Change in scores on the Global Functioning: Social Scale. Scores on this measure range from 1-10 with higher scores indicating greater social functioning
4 weeks
Change from baseline in role functioning
Time Frame: 4 weeks
Change in scores on the Global Functioning: Role Scale. Scores on this measure range from 1-10 with higher scores indicative of greater role functioning.
4 weeks
Change from baseline in health-related quality of life
Time Frame: 4 weeks
Change in scores on the RAND 36-Item Health Survey.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in suicidality
Time Frame: 4 weeks
Change in occurrence in suicidal thoughts or behaviors as assessed using the Columbia Suicide Severity Rating Scale. This is a categorical rating scale that identifies the presence or absence of specific levels of severity of suicidal ideation and behavior.
4 weeks
Change from baseline in substance use severity
Time Frame: 4 weeks
Change in scores on the HABITS scale. This scale assesses the absolute values of use of specific substances (e.g., number of cigarettes smoked)
4 weeks
Change from baseline in service utilization
Time Frame: 4 weeks
Change in scores on the Modified Service Use and Resources Form for Schizophrenia
4 weeks
Change in Sleep
Time Frame: 4 weeks
Change in scores on the Pittsburgh Sleep Quality Index.
4 weeks
Change from baseline in medication adherence
Time Frame: 4 weeks
Change in scores on the Medication Adherence rating Scale. Scores on this scale range from 0-10 with higher scores indicative of greater medication adherence.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicholas Breitborde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2019

Primary Completion (Estimated)

December 7, 2025

Study Completion (Estimated)

December 7, 2025

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019H0424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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