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| ID | Type | Description | Link |
|---|---|---|---|
| P2CHD086844 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of Colorado, Denver | OTHER |
| Medical University of South Carolina | OTHER |
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The goal of this study is to examine the effect of repetitive acute intermittent hypoxia on motor learning abilities in able-bodied individuals for subsequent study in individuals with incomplete spinal cord injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repetitive Acute Intermittent Hypoxia | Experimental | 5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals |
|
| SHAM Acute Intermittent Hypoxia | Sham Comparator | 5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals |
|
| Control | No Intervention | The control group received no AIH exposure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute Intermittent Hypoxia | Other | 5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Corticospinal Excitability | Transcranial magnetic stimulation (TMS) can be applied over the primary motor cortex to examine changes in corticospinal excitability. The downstream muscle activation can be recorded with surface EMG as a motor-evoked potential (MEP). The peak-to-peak MEP amplitude (mV) is as an index of corticospinal excitability. A randomized sequence of TMS intensities can be applied over the primary motor cortex, ranging from 90-140% of the participants' resting motor threshold (RMT). The mean MEP amplitude will be plotted against the corresponding stimulation intensity to produce the recruitment curve. The area under the recruitment curve is an additional index of corticospinal excitability (mV/% RMT). | We will measure TMS before the start of 5 consecutive days of AIH or SHAM treatment. We will measure TMS within 24 hours of the final treatment. |
| Step Length Asymmetry | Step length asymmetry will be quantified as the ratio of the normalized difference in step lengths between the fast and slow legs during split-belt motor adaptation: (Fast leg - Slow leg step length) / (Fast leg + Slow leg step length). | We will compare asymmetry 15 minutes after the final AIH treatment to asymmetry following no treatment (control group). |
| Step Time Asymmetry | Step time asymmetry will be quantified as the ratio of the normalized difference in step times between the fast and slow legs during split-belt motor adaptation: (Fast leg - Slow leg step time) / (Fast leg + Slow leg step time). | We will compare asymmetry 15 minutes after the final AIH treatment to asymmetry following no treatment (control group). |
| Net Metabolic Power | Using expired gas analyses, we will calculate net metabolic power by inputting steady-state values for V̇O₂ and V̇CO₂ into standard regression equations (W), subtracting resting values, and normalizing the result to each participant's body weight (kg). | We will compare net metabolic power 15 minutes after the final AIH treatment to asymmetry following no treatment (control group). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| University of Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39994358 | Result | Bogard AT, Hembree TG, Pollet AK, Smith AC, Ryder SC, Marzloff GE, Tan AQ. Intermittent hypoxia-induced enhancements in corticospinal excitability predict gains in motor learning and metabolic efficiency. Sci Rep. 2025 Feb 24;15(1):6614. doi: 10.1038/s41598-025-90890-8. | |
| 37983629 | Result | Bogard AT, Hemmerle MR, Smith AC, Tan AQ. Enhanced motor learning and motor savings after acute intermittent hypoxia are associated with a reduction in metabolic cost. J Physiol. 2024 Nov;602(21):5879-5899. doi: 10.1113/JP285425. Epub 2023 Nov 20. |
| Label | URL |
|---|---|
| Related Info | View source |
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Participants were randomly assigned to their respective groups and completed either AIH, SHAM, or no treatment before undergoing motor learning assessments using a split-belt treadmill paradigm. Qualifying participants also received corticospinal excitability assessments using transcranial magnetic stimulation (TMS).
Individuals were recruited through advertisements in Colorado, with recruitment occurring from May 2022 through January 2025. A total of 56 participants were enrolled across both studies. Part 1: Motor Learning (N = 30) & Part 2: Corticospinal Indices of Motor Learning (N = 26).
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| ID | Title | Description |
|---|---|---|
| FG000 | Repetitive Acute Intermittent Hypoxia | 5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals |
| FG001 | SHAM Acute Intermittent Hypoxia | 5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals |
| FG002 | Control Group | No AIH or SHAM exposure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Repetitive Acute Intermittent Hypoxia | 5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals |
| BG001 | SHAM Acute Intermittent Hypoxia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Corticospinal Excitability | Transcranial magnetic stimulation (TMS) can be applied over the primary motor cortex to examine changes in corticospinal excitability. The downstream muscle activation can be recorded with surface EMG as a motor-evoked potential (MEP). The peak-to-peak MEP amplitude (mV) is as an index of corticospinal excitability. A randomized sequence of TMS intensities can be applied over the primary motor cortex, ranging from 90-140% of the participants' resting motor threshold (RMT). The mean MEP amplitude will be plotted against the corresponding stimulation intensity to produce the recruitment curve. The area under the recruitment curve is an additional index of corticospinal excitability (mV/% RMT). | A total of 56 participants were enrolled for this study: Part 1: Motor Learning (N = 30; AIH group + control group) & Part 2: Corticospinal Indices of Motor Learning (N = 36; AIH group + SHAM group). Changes in corticospinal excitability reflect the results from Part 2 of the study, which consisted of an AIH group and a SHAM group (i.e., blinded normoxia). | Posted | Mean | Standard Error | mV*percentage of RMT | We will measure TMS before the start of 5 consecutive days of AIH or SHAM treatment. We will measure TMS within 24 hours of the final treatment. |
2 years 6 months
No serious adverse events were encountered during clinical trial period (see table). Strict inclusion and exclusion criteria were adhered such that intervention does not increase of All-Cause Mortality. Study does not increase risk of adverse events as a consequence of participation.
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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 | Repetitive Acute Intermittent Hypoxia | 5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Q. Tan | University of Colorado, Boulder | 303-735-0259 | andrew.tan@colorado.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 14, 2025 | Apr 29, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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This study design is twofold. The first study examines the effects of AIH on motor learning using an AIH group and a control group (total N = 30). The second part of this study examines corticospinal indices of motor learning using an AIH group and a SHAM group (i.e., blinded normoxia; total N = 26).
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| SHAM Acute Intermittent Hypoxia | Other | 5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals |
|
| Boulder |
| Colorado |
| 80309 |
| United States |
| Related Info | View source |
5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals
| BG002 | Control Group | No AIH or SHAM exposure |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Repetitive Acute Intermittent Hypoxia | 5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals |
| OG001 | SHAM Acute Intermittent Hypoxia | 5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals |
|
|
|
| Primary | Step Length Asymmetry | Step length asymmetry will be quantified as the ratio of the normalized difference in step lengths between the fast and slow legs during split-belt motor adaptation: (Fast leg - Slow leg step length) / (Fast leg + Slow leg step length). | A total of 56 participants were enrolled for this study: Part 1: Motor Learning (N = 30; AIH group + control group) & Part 2: Corticospinal Indices of Motor Learning (N = 36; AIH group + SHAM group). Changes in step length asymmetry reflect the results from Part 1 of the study, which consisted of an AIH group and a control group. | Posted | Mean | Standard Deviation | Ratio | We will compare asymmetry 15 minutes after the final AIH treatment to asymmetry following no treatment (control group). |
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|
|
|
| Primary | Step Time Asymmetry | Step time asymmetry will be quantified as the ratio of the normalized difference in step times between the fast and slow legs during split-belt motor adaptation: (Fast leg - Slow leg step time) / (Fast leg + Slow leg step time). | A total of 56 participants were enrolled for this study: Part 1: Motor Learning (N = 30; AIH group + control group) & Part 2: Corticospinal Indices of Motor Learning (N = 36; AIH group + SHAM group). Changes in step time asymmetry reflect the results from Part 1 of the study, which consisted of an AIH group and a control group. | Posted | Mean | Standard Deviation | Ratio | We will compare asymmetry 15 minutes after the final AIH treatment to asymmetry following no treatment (control group). |
|
|
|
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| Primary | Net Metabolic Power | Using expired gas analyses, we will calculate net metabolic power by inputting steady-state values for V̇O₂ and V̇CO₂ into standard regression equations (W), subtracting resting values, and normalizing the result to each participant's body weight (kg). | A total of 56 participants were enrolled for this study: Part 1: Motor Learning (N = 30; AIH group + control group) & Part 2: Corticospinal Indices of Motor Learning (N = 36; AIH group + SHAM group). Changes in net metabolic power reflect the results from Part 1 of the study, which consisted of an AIH group and a control group. One participant was excluded from metabolic analysis due to RER > 1.0, violating assumption that primarily oxidative pathways were being utilized. | Posted | Mean | Standard Deviation | W/kg | We will compare net metabolic power 15 minutes after the final AIH treatment to asymmetry following no treatment (control group). |
|
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|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Control Group | No AIH or SHAM exposure | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | SHAM Acute Intermittent Hypoxia | Blinded normoxia (5 consecutive days of 21% O2) | 0 | 13 | 0 | 13 | 0 | 13 |
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| D014947 | Wounds and Injuries |