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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | 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) |
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| Sequence 2 | Experimental | 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 |
|
| Sequence 3 | Experimental | 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 |
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| Sequence 4 | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention 1 | Device | 15 bouts of 2mins:1min hypoxia:hyperoxia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensory Function | Thermal thresholds. Average reported. | 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. | 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 | Every 10 minutes for 60 minutes post intervention, average reported |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark D Bishop, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unversity of Florida | Gainesville | Florida | 32611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 |
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| FG001 | Sequence 2 | 2. 15 bouts of 1mins:1min hypoxia:hyperoxia 3. 8 bouts of 2mins:1min hypoxia:hyperoxia 4. 15 bouts of 1min:1min normoxia 1. 15 bouts of 2mins:1min hypoxia:hyperoxia |
| FG002 | Sequence 3 | 3. 8 bouts of 2mins:1min hypoxia:hyperoxia 4. 15 bouts of 1min:1min normoxia
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| FG003 | Sequence 4 | 4. 15 bouts of 1min:1min normoxia
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | 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 |
| BG001 | Sequence 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensory Function | Thermal thresholds. Average reported. | A 2-way analysis of co-variance with repeated measures (time*intervention) was conducted with gender as the covariate. | Posted | Mean | Standard Deviation | Degrees celsius | Every 10 minutes for 60 minutes post intervention, average reported |
|
2 weeks
The definitions do not differ
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All participants completed each protocol in a a randomly assigned order. Therefore all adverse event data are combined.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Bishop | University of Florida | 3522736112 | bish@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2021 | May 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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Within subjects design with randomization of presentation of four different hypoxia/normoxia intervals.
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Participants can't see the device and therefore the settings. The assessment of sensory function is done by a separate investigator who did not participate in the set up of the hypoxicator
| Intervention 2 | Device | 15 bouts of 1mins:1min hypoxia:hyperoxia |
|
| Intervention 3 | Device | 8 bouts of 2mins:1min hypoxia:hyperoxia |
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| Intervention 4 (sham) | Device | 15 bouts of 1min:1min normoxia |
|
15 bouts of 1mins:1min hypoxia:hyperoxia 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia 15 bouts of 2mins:1min hypoxia:hyperoxia
| BG002 | Sequence 3 | 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia 15 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1mins:1min hypoxia:hyperoxia |
| BG003 | Sequence 4 | 15 bouts of 1min:1min normoxia 15 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1mins:1min hypoxia:hyperoxia 8 bouts of 2mins:1min hypoxia:hyperoxia |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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3) 8 bouts of hypoxia for 2 minutes, normoxia to hyperoxia 1 minute; |
| OG003 | Intervention 4 (Sham) | 4) normoxia |
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| Primary | 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. | 2-way repeated measures ANOVA with gender as the covariate | Posted | Mean | Standard Deviation | score on a scale | Every 10 minutes for 60 minutes post intervention, average reported |
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| Primary | Sensory Function - Pressure | Pressure threshold is the force at which the sensation of pressure first is considered painful by the participant, average reported | A 2-way analysis of co-variance with repeated measures (time*intervention) was conducted with gender as the covariate. | Posted | Mean | Standard Deviation | kilograms force | Every 10 minutes for 60 minutes post intervention, average reported |
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| 22 |
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