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NCT04368039

Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

StatusTerminated
PhaseNot applicable
Primary completion
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 8 versions: 7 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial terminated Sponsor's reason: Vendor unable to continue to provide oxygen concentrators Show 6 more changesShow less
    • Final enrollment: 3 participants (planned 20)
    • Primary completion date changed from estimate of Dec 7, 2026 to Oct 13, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site details revised
    • Publications: details revised at 13 of 20 entries
  2. Primary and study completion dates: Dec 7, 2025 to Dec 7, 2026v7
  3. Primary and study completion dates: Dec 7, 2024 to Dec 7, 2025v5
  4. Primary and study completion dates: Dec 7, 2023 to Dec 7, 2024v4
  5. Primary and study completion dates: Dec 7, 2022 to Dec 7, 2023v3
  6. Primary and study completion dates: Dec 7, 2020 to Dec 7, 2022
    • Secondary endpoints: details revised at 3 of 5 entries
    v2
  7. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed

Endpoints

Primary

Change from baseline in cognitive functioning
Timeframe: 4 weeks
Change from baseline in quality of life
Timeframe: 4 weeks
Change from baseline in social functioning
Timeframe: 4 weeks
Change from baseline in role functioning
Timeframe: 4 weeks
Change from baseline in health-related quality of life
Timeframe: 4 weeks

Secondary (5)

Change from baseline in suicidality
Change from baseline in substance use severity
Change from baseline in service utilization
Change in Sleep
Change from baseline in medication adherence

Arms and interventions

Normobaric Oxygen Therapy (40% FiO2)Experimental

4 weeks of nightly normobaric oxygen therapy (40% FiO2)

Placebo ConditionPlacebo comparator

4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2)

Devices: Normobaric Oxygen, Placebo

Sites

1 site in 1 country

  • Harding HospitalColumbus, Ohio, United States