An interventional study of Intervention 1 and Intervention 2 in Sensitivity, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by University of Florida · Not applicable, Interventional, and Other
Exposure to acute intermittent hypoxia (AIH) can facilitate of motor output but no studies of sensory effects has been reported.
Despite the strong results of motor studies, the affects of AIH on sensory function has not been established. We will use a commercially-available hypoxicator that can be programmed to achieve a targeted level of arterial oxygen saturation. We plan to compare 3 previously published protocols that have generated motor facilitation (and a sham condition) to characterize and effects on sensory function in healthy adults.
Exclusion Criteria:
Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham)
Device: Intervention 1 · Device: Intervention 2 · Device: Intervention 3 · Device: Intervention 4 (sham)
Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia
Device: Intervention 1 · Device: Intervention 2 · Device: Intervention 3 · Device: Intervention 4 (sham)
Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia
Device: Intervention 1 · Device: Intervention 2 · Device: Intervention 3 · Device: Intervention 4 (sham)
15 bouts of 1min:1min normoxia (sham) Intervention 1: 15 bouts of 2mins:1min hypoxia:hyperoxia Intervention 2: 15 bouts of 1mins:1min hypoxia:hyperoxia Intervention 3: 8 bouts of 2mins:1min hypoxia:hyperoxia
Device: Intervention 1 · Device: Intervention 2 · Device: Intervention 3 · Device: Intervention 4 (sham)
15 bouts of 2mins:1min hypoxia:hyperoxia
15 bouts of 1mins:1min hypoxia:hyperoxia
8 bouts of 2mins:1min hypoxia:hyperoxia
15 bouts of 1min:1min normoxia
Sensory Function
Thermal thresholds. Average reported.
Time frame: Every 10 minutes for 60 minutes post intervention, average reported
Temporal Sensory Summation
Temporal summation represents increases in ratings of pain intensity measured using a numeric pain rating scale (0-no pain to 100-worst pain imaginable) to repeated heat stimuli of the same intensity; that is, "summation" represents increases in participant ratings of pain despite the maintenance of a standard temperature and is calculated as the difference between pain rating 1 and pain rating 6. Positive difference scores indicate that pain reported increased over the 6 pulses of heat. Here, the average difference across participants and over time is reported.
Time frame: Every 10 minutes for 60 minutes post intervention, average reported
Sensory Function - Pressure
Pressure threshold is the force at which the sensation of pressure first is considered painful by the participant, average reported
Time frame: Every 10 minutes for 60 minutes post intervention, average reported
| Milestone | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 |
|---|---|---|---|---|
| Started | 7 | 5 | 5 | 5 |
| Completed | 5 | 5 | 5 | 5 |
| Not completed | 2 | 0 | 0 | 0 |
Thermal thresholds. Average reported.
| Degrees celsius | Intervention 1 | Intervention 2 | Intervention 3 | Intervention 4 (Sham) |
|---|---|---|---|---|
| Sensory Function | 46.7 ± 1.5 | 46.4 ± 1.9 | 46.1 ± 1.9 | 45.9 ± 2.1 |
Temporal summation represents increases in ratings of pain intensity measured using a numeric pain rating scale (0-no pain to 100-worst pain imaginable) to repeated heat stimuli of the same intensity; that is, "summation" represents increases in participant ratings of pain despite the maintenance of a standard temperature and is calculated as the difference between pain rating 1 and pain rating 6. Positive difference scores indicate that pain reported increased over the 6 pulses of heat. Here, the average difference across participants and over time is reported.
| score on a scale | Intervention 1 | Intervention 2 | Intervention 3 | Intervention 4 (Sham) |
|---|---|---|---|---|
| Temporal Sensory Summation | 17.4 ± 13.3 | 11.7 ± 10.2 | 10.9 ± 11.2 | 11.9 ± 15.6 |
Pressure threshold is the force at which the sensation of pressure first is considered painful by the participant, average reported
| kilograms force | Intervention 1 | Intervention 2 | Intervention 3 | Intervention 4 (Sham) |
|---|---|---|---|---|
| Sensory Function - Pressure | 4.4 ± 3.4 | 4.6 ± 2.5 | 4.3 ± 2.8 | 4.3 ± 3.1 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Continuous(years) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Total |
|---|---|---|---|---|---|
| Mean | 26.4 ± 6.3 | 19.2 ± 1.1 | 20.8 ± 2.0 | 20.8 ± 2.1 | 22.0 ± 5.1 |
| Sex: Female, Male(Participants) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Total |
|---|---|---|---|---|---|
| Female | 4 | 3 | 3 | 0 | 10 |
| Male | 1 | 2 | 2 | 5 | 10 |
| Race (NIH/OMB)(Participants) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 3 | 2 | 1 | 3 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 2 | 3 | 3 | 1 | 9 |
| More than one race | 0 | 0 | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Total |
|---|---|---|---|---|---|
| United States | 5 | 5 | 5 | 5 | 20 |
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University of Florida