Trial · NCT02323698
Effects of Caffeine and Intermittent Hypoxia on Leg Function in Human Spinal Cord Injury
NCT02323698, Phase 1, Phase 2, Completed, Spaulding Rehabilitation Hospital; results first posted 2022-08-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Caffeine and Intermittent Hypoxia on Leg Function in Human Spinal Cord Injury. Trials, record NCT02323698. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02323698
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Caffeine and Intermittent Hypoxia on Leg Function in Human Spinal Cord Injury
- NCT number
- NCT02323698
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Conditions
- Spinal Cord Injuries
- Interventions
- Caffeine, AIH, Placebo, SHAM
- First posted
- 2014-12-23
- Last updated
- 2023-12-13
- Results first posted
- 2022-08-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 10 Meter Walk Time | Baseline, after intervention (day 5), and at follow-ups (one week and two weeks) | Speed will be assessed using the time required to walk 10 meters (10MWT) relative to baseline. |
| Secondary | 6 Minute Walk Test | Baseline, after intervention (day 5), and at follow-ups (one week and two weeks) | Measure participant's distance walked in 6 minutes (meters). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 10 Meter Walk Time | Baseline, after intervention (day 5), and at follow-ups (one week and two weeks) | Seconds | MEAN | |
| SECONDARY | 6 Minute Walk Test | Baseline, after intervention (day 5), and at follow-ups (one week and two weeks) | Meters | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 10 Meter Walk Time | Caffeine/AIH | Day 5 (Relative to Baseline) | -5.0 | Standard Error 2.2 | Seconds |
| 10 Meter Walk Time | Placebo/AIH | Day 5 (Relative to Baseline) | -4.9 | Standard Error 2.2 | Seconds |
| 10 Meter Walk Time | Caffeine/SHAM | Day 5 (Relative to Baseline) | -4.6 | Standard Error 2.1 | Seconds |
| 10 Meter Walk Time | Caffeine/AIH | Day 12 (Relative to Baseline) | -5.5 | Standard Error 2.7 | Seconds |
| 10 Meter Walk Time | Placebo/AIH | Day 12 (Relative to Baseline) | -1.7 | Standard Error 1.3 | Seconds |
| 10 Meter Walk Time | Caffeine/SHAM | Day 12 (Relative to Baseline) | 0.9 | Standard Error 1.5 | Seconds |
| 10 Meter Walk Time | Caffeine/AIH | Day 19 (Relative to Baseline) | -6.5 | Standard Error 3.3 | Seconds |
| 10 Meter Walk Time | Placebo/AIH | Day 19 (Relative to Baseline) | 0.4 | Standard Error 2.6 | Seconds |
| 10 Meter Walk Time | Caffeine/SHAM | Day 19 (Relative to Baseline) | -0.1 | Standard Error 0.6 | Seconds |
| 6 Minute Walk Test | Caffeine/AIH | Day 5 (Relative to Baseline) | 24.1 | Standard Error 8.3 | Meters |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Caffeine/AIH First, Then Placebo/AIH, Then Caffeine/SHAM | 2 | |
| Overall Study | STARTED | Placebo/AIH First, Then Caffeine/AIH, Then Caffeine/SHAM | 2 | |
| Overall Study | STARTED | Caffeine/SHAM First, Then Caffeine/AIH, Then Placebo/AIH | 2 | |
| Overall Study | STARTED | Caffeine/AIH First, Then Caffeine/SHAM, Then Placebo/AIH | 2 | |
| Overall Study | STARTED | Placebo/AIH First, Then Caffeine/SHAM, Then Caffeine/AIH | 2 | |
| Overall Study | STARTED | Caffeine/SHAM First, Then Placebo/AIH, Then Caffeine/AIH | 2 | |
| Overall Study | Completed First Intervention (5 Days) | Caffeine/AIH First, Then Placebo/AIH, Then Caffeine/SHAM | 2 | |
| Overall Study | Completed First Intervention (5 Days) | Placebo/AIH First, Then Caffeine/AIH, Then Caffeine/SHAM | 2 | |
| Overall Study | Completed First Intervention (5 Days) | Caffeine/SHAM First, Then Caffeine/AIH, Then Placebo/AIH | 2 | |
| Overall Study | Completed First Intervention (5 Days) | Caffeine/AIH First, Then Caffeine/SHAM, Then Placebo/AIH | 2 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Caffeine/AIH | 0 | 12 |
| Total, all-cause mortality | Placebo/AIH | 0 | 12 |
| Total, all-cause mortality | Caffeine/SHAM | 0 | 12 |
| Total, other adverse events | Caffeine/AIH | 0 | 12 |
| Total, other adverse events | Placebo/AIH | 0 | 12 |
| Total, other adverse events | Caffeine/SHAM | 0 | 12 |
| Total, serious adverse events | Caffeine/AIH | 0 | 12 |
| Total, serious adverse events | Placebo/AIH | 0 | 12 |
| Total, serious adverse events | Caffeine/SHAM | 0 | 12 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD081274 | Mechanisms of intermittent hypoxia-induced motor recovery in persons with SCI | TRUMBOWER, RANDY D | SPAULDING REHABILITATION HOSPITAL | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2014 to 2018 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02323698
GET https://conductscience.org/api/trials/v1/NCT02323698/flow?page=2