Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Nicholas Breitborde
Study ID
NCT04368039
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Normobaric Oxygen — DEVICE
    40% FiO2 for 4 weeks
  • Placebo — DEVICE
    21% FiO2 for 4 weeks

Study Details

Single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.

Key Dates

Start date
Dec 4, 2019
Status verified
Feb 2026
Primary completion
Dec 7, 2026
Completion
Dec 7, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Normobaric Oxygen Therapy (40% FiO2)
    4 weeks of nightly normobaric oxygen therapy (40% FiO2)
  • Placebo Comparator: Placebo Condition
    4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2)

Primary Outcome Measure

Change from baseline in cognitive functioning [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Harding HospitalColumbusOhio43210
Nicholas Breitborde, PhD
614-685-6052

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