Effects of Caffeine and Intermittent Hypoxia on Leg Function in Human Spinal Cord Injury

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

January 1, 2019

Primary Completion Date

March 19, 2021

Study Completion Date

February 19, 2022

Conditions
Spinal Cord Injuries
Interventions
DRUG

Caffeine

Subjects will ingest capsules containing caffeine (up to 6mg/kg). Experiments will begin 30min after consumption to approximately coincide with peak plasma concentrations.Throughout the 30min wait time and experimentation, blood pressure and heart rate will be monitored.

OTHER

AIH

Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of FIO2 (fraction of inspired oxygen) = 0.10±0.02 (hypoxia). Throughout experimentation, blood pressure and heart rate will be monitored.

OTHER

Placebo

This is a placebo counterpart to the caffeine drug. Subjects will ingest capsules containing dextrose. Experiments will begin 30min after consumption to mimic the caffeine drug protocol. Throughout experimentation, blood oxygenation, blood pressure and heart rate will be monitored.

OTHER

SHAM

This is a placebo counterpart to breathing intermittent low oxygen. Participants will breathe intermittent room air via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of FIO2 (fraction of inspired oxygen) = 0.21±0.02 (normoxia). Throughout experimentation, blood pressure and heart rate will be monitored.

Trial Locations (1)

02138

Spaulding Rehabilitation Hospital, Cambridge

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Spaulding Rehabilitation Hospital

OTHER

NCT02323698 - Effects of Caffeine and Intermittent Hypoxia on Leg Function in Human Spinal Cord Injury | Biotech Hunter | Biotech Hunter