Intermittent Hypoxia-initiated Plasticity in Humans: A Multi-pronged Therapeutic Approach to Treat Sleep Apnea and Overlapping Co-morbidities

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 1, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Obstructive Sleep Apnea
Interventions
OTHER

Mild Intermittent Hypoxia

The MIH protocol will be comprised of a 20-minute baseline period followed by exposure to twelve two-minute episodes of hypoxia \[partial pressure of end-tidal oxygen (PETO2)= 50 mmHg\]. Each episode will be interspersed with a 2-minute recovery period under normoxic conditions. The final episode will be followed by a 30-minute end-recovery period. The partial pressure of end-tidal carbon dioxide (PETCO2) will be sustained 2 mmHg above baseline values for the last ten minutes of baseline and throughout the remainder of the protocol. To rapidly induce a PETO2 of 50 mmHg participants will inspire a gas mixture comprised of 8 % oxygen and 92 % nitrogen from a non-diffusible bag. To maintain PETO2 (i.e. 50 mmHg) and PETCO2 (i.e. 2 mmHg above baseline) at the desired levels supplemental oxygen and carbon dioxide will be added to the inspiratory line from the output of a flow meter device that receives inputs from tanks of 100 % oxygen and 100 % carbon dioxide.

OTHER

Sham MIH

"During sham MIH the participants will be exposed to compressed air (the equivalent of room air)."

Trial Locations (1)

48201-1916

RECRUITING

John D. Dingell VA Medical Center, Detroit, MI, Detroit

All Listed Sponsors
collaborator

John D. Dingell VA Medical Center

FED

lead

VA Office of Research and Development

FED