CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
Intermittent Hypoxia (IH) +1 moredevice
Likely dose
Intermittent hypoxia (FIO2 = 0.09-0.12) alternating with normoxia (FIO2 = 0.21) for 6-minute and 3-minute intervals respectively, daily for 5 consecutive days, one hour per sessionAI-extracted
Key inclusion· 4
  • ✓Lower extremity weakness or paralysis at C5 or below from spinal cord injury present for at least one year
  • ✓ASIA Classification A, B, C, or D
  • ✓Overweight or obese (BMI ≥22.0 for SCI participants)
  • ✓Resting oxygen saturation ≥95%
Key exclusion· 8
  • ✕Currently hospitalized
  • ✕Resting heart rate ≥120 BPM
  • ✕Resting systolic blood pressure >180 mm Hg
  • ✕Resting diastolic blood pressure >100 mm Hg

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02973438
NCT02973438N/ACompleted
CompareCT.gov

Effects of Acute Intermittent Hypoxia (AIH) on Metabolism and Dysglycemia, in Overweight/Obese Persons With Spinal Cord Injuries (SCI)

University of Miami·interventional·Posted Nov 25, 2016·Updated Dec 17, 2020

In Brief

A clinical study evaluating Intermittent Hypoxia (IH) and SHAM for Spinal Cord Injuries and 2 related conditions. Completed, enrolled 6 participants across 1 site.

Detailed Summary

The purpose of this research is to examine changes in blood glucose control and metabolism in individuals with SCI and non injured controls at rest and during exercise after five days of exposure to IH. This response will be compared with breathing normal room air (a SHAM control).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Cord Injuries, Obesity, Insulin Resistance
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 25, 2016
Enrollment StartDec 1, 2016
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 9.6 years ago

Interventions

Intermittent Hypoxia (IH)device

Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.

SHAMdevice

Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).