Intermittent HypoxiaNCT05463042
Intermittent Hypoxia and Balance Control
A study testing Intermittent Hypoxia in people with Intermittent Hypoxia and Normoxia, run by University of Texas at Austin at 1 site in United States.
Trial summary
This study aims to determine the effect of acute mild intermittent hypoxia on ankle plantarflexor muscle output during balance regulation and walking in younger and older adults. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Hypoxia, Normoxia
- What is being tested?
- Intermittent Hypoxia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 21 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to stand and walk for more than 5 minutes without assistance.
Who cannot join
- Have high blood pressure (above 130/90 mmHg)
- Are smokers
- Are pregnant
- Have body mass index more than 35 kg/m2
- Have a history of falls in the past 6 months
- Have a history of neuromuscular deficits that may affect gait
Show all 9Show fewer
- Have a history of cardiovascular disease
- Have a history of diabetes or lung disease
- Are taking medication affecting the cardiovascular system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intermittent Hypoxia on Balance Control During Standing and Walking in Healthy Adults
This study aims to determine the effect of acute mild intermittent hypoxia on ankle plantarflexor muscle output during balance regulation and walking in younger and older adults. Fifteen younger adults and 15 older adults will be recruited to participate in the cross-over design study that requires 2 visits (at least 1-week apart). Participants will be pseudo-randomly assigned to receive either intermittent hypoxia or sham during the first visit, and then switch over to receive sham or intermittent hypoxia during the 2nd visit. Muscle activation patterns and kinetic and kinematics during standing and walking will be recorded before and after the intermittent hypoxia/sham. It is hypothesized that compared to the sham condition, both younger and older participants will show greater increases in ankle plantarflexor muscle activation during gait and balance assessments following intermittent hypoxia.
Read the detailed description
Procedure:
This is a cross-over design study that requires 2 visits (at least 1-week apart). Fifteen younger adults and 15 older adults will be recruited. Participants will be pseudo-randomly assigned to receive either intermittent hypoxia or sham during the first visit, and then switch over to receive sham or intermittent hypoxia during the 2nd visit.
During each visit, participants will first perform Gait and Balance Assessments (PRE), followed by the Intermittent Hypoxia (or sham) protocol, and then perform Gait and Balance Assessments (POST) again. The total time is approximately 2.5 hours for each visit.
Balance and Gait Assessments The consent process and Balance and Gait Assessments will take place in BEL 530.
During Balance and Gait Assessments, participants will be asked to wear tight-fitting shorts and shirt for accurate marker positioning. Approximately 39 reflective markers will be attached to target locations on the individuals' body (the head, arms, wrists, hands, trunk, pelvis, legs and feet) according to the Vicon Full-Body Plug-In Gait Model.
A study team member will attach surface electrodes over the tibialis anterior and soleus muscles to record the muscle activation patterns with a wireless Electromyography (EMG) system (Delsys Inc., Natick, MA). Next, a study team member will assist the participant to wear a safety harness that will be attached to an overhead support beam.
For Balance Assessment, participants will stand on the treadmill with their feet shoulder-width apart. A 30-second quiet standing trial will be recorded. Next, participants will be instructed to maintain upright posture when the treadmill shifts forward or backward at unknown times (perturbed standing). The treadmill will shift approximately 3 cm. Based on our previous experiment, this distance is sufficient to trigger a response without inducing a fall. Three forward and 3 backward treadmill shifts will be delivered in a randomized order. Finally, participants will be asked to close their eyes and repeat the quiet standing and perturbed standing trials. A 10-camera Vicon Nexus motion capture system (Vicon, Oxford Metrics, UK) will be used to record whole body kinematics. Ground reaction forces under each belt will be recorded. A handrail is located on either side of the treadmill.
For Gait Assessments, participants will walk on the treadmill at their comfortable and fast walking speeds. The comfortable speed will be determined by gradually increasing the treadmill speed until the participant confirms that it reaches their comfortable regular walking speed. The fast speed will be determined by gradually increasing the treadmill speed until the participant confirms that it reaches the maximum speed that they can walk safely. A 30-second walking trial will be recorded for each speed.
Following Balance and Gait Assessment, a testing team member will escort the participant to BEL819 Clinical Exercise Physiology Laboratory to perform Intermittent Hypoxia (or sham).
Intermittent hypoxia Intermittent hypoxia will be performed in BEL819 Clinical Exercise Physiology Laboratory. Intermittent hypoxia is routinely performed in this laboratory (IRB protocols 2017090015, 2018110129, 2019070088, and 202005018). Intermittent hypoxia consisting of a limited number (5-10/day) of short (4-10 min) bouts of mild hypoxia (oxygen levels between 10-12%) leads to cumulative and sustained beneficial physiological responses. Preliminary data collected in the Clinical Exercise Physiology Laboratory show that a fraction of oxygen of 11±1% corresponds to an arterial oxygen saturation of 80±2% in middle-aged individuals. Participants will be sitting during the entire breathing protocol. Hypoxic air will be inhaled through a mask connected to a two-way non-rebreathing valve, which will itself be connected to a 5-liter non-diffusing gas bag (Hans Rudolph, Inc, USA). The rebreathing bag will be connected to a certified medical grade gas tank containing 11% oxygen and a balance of nitrogen. The intermittent hypoxia protocol will consist of eight 4-min cycles of breathing hypoxic air interspersed with normoxic cycles breathing room air. After four min of hypoxia, participants will be switched back to breathing room air until resaturation, which takes approximately one minute. Once arterial oxygen saturation reaches baseline levels, participants will be switched back to breathing hypoxic air, beginning the next hypoxic cycle. Unlike chronic hypoxic exposure, risks associated with an acute hypoxic exposure of three 4-min cycles are minimal, and no adverse events were reported during intermittent hypoxia in our participants.
During the sham condition, compressed air (21% oxygen) from a gas tank will be delivered throughout the protocol instead of 11% oxygen. Participants will not receive information about which condition (Intermittent hypoxia or sham) they are experiencing during the trials.
Pulmonary gas exchange Breath-by-breath measures of pulmonary gas exchange such as volume of oxygen and carbon dioxide, respiratory rate, tidal volume, minute ventilation and fraction of inspired oxygen will be determined from a pneumotachometer (Ultima Cardio2, MGC Diagnostics, MN, USA) throughout the intermittent hypoxia. The pneumotachometer will be mounted between the mask and the non-rebreathing valve of the breathing circuit. The pneumotachometer, mouthpiece and non-rebreathing valve will be disinfected in a 10% bleach and water solution for 60 minutes and rinse thoroughly with tap water for 5 minutes between each use. Each participant will have a face mask that will only be used by him/her.
Hemodynamics An arterial waveform obtained by finger plethysmography from the middle finger of the left hand will be continuously recorded (NOVA, Finapres Medical Systems, Amsterdam, Netherlands) during the intermittent hypoxia. Systolic, diastolic and mean arterial pressure, heart rate, stroke volume, cardiac output and total peripheral resistance will be derived from the arterial waveform, a method which has been validated against invasive measures [9]. All data will be recorded in LabChart (Powerlab, ADInstruments Inc., CO, USA) for later analysis.
Arterial oxygen saturation Arterial oxygen saturation will continuously be monitored by pulse oximetry (NOVA, Finapres Medical Systems, Amsterdam, Netherlands) throughout the intermittent hypoxia. The pulse oximeter probe will be applied to the index finger of the left hand.
Following intermittent hypoxia (or sham), a testing team member will escort the participant back to BEL530 to perform Balance and Gait Assessment. After the assessment, a testing team member will remove the electrodes and markers from the participant.
- Conditions
- Intermittent Hypoxia, Normoxia
- Being tested
- Intermittent Hypoxia, Normoxia (sham)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent HypoxiaBehavioural
During the intermittent hypoxia session, participants will be sitting during the entire breathing protocol. Hypoxic air will be inhaled through a mask connected to a two-way non-rebreathing valve, which will itself be connected to a 5-liter non-diffusing gas bag (Hans Rudolph, Inc, USA). The rebreathing bag will be connected to a certified medical grade gas tank containing 11% oxygen and a balance of nitrogen. The intermittent hypoxia protocol will consist of eight 4-min cycles of breathing hypoxic air interspersed with normoxic cycles breathing room air. After four min of hypoxia, participants will be switched back to breathing room air until resaturation, which takes approximately one minute. Once arterial oxygen saturation reaches baseline levels, participants will be switched back to breathing hypoxic air, beginning the next hypoxic cycle.
Normoxia (sham)Behavioural
During the sham condition, compressed air (21% oxygen) from a gas tank will be delivered throughout the protocol instead of 11% oxygen. Participants will not receive information about which condition (Intermittent hypoxia or sham) they are experiencing during the trials.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Hypoxia | Experimental | Participants will receive intermittent hypoxia and perform balance and gait assessments before and after the intermittent hypoxia session. Receives: Behavioral: Intermittent Hypoxia |
| Normoxia (sham) | Sham comparator | Participants will receive normoxia and perform balance and gait assessments before and after the normoxia session. Receives: Behavioral: Normoxia (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soleus muscle activation pattern
changes in peak soleus muscle EMG magnitude following perturbation onset during standing from pre to post intermittent hypoxia will be calculated
Measured: pre (2o minutes before) and post (20 minutes after) intermittent hypoxia or sham session
Ankle plantarflexion torque
Changes in peak ankle plantarflexion torque production during walking from pre to post intermittent hypoxia will be calculated.
Measured: pre (20 minutes before) and post (20 minutes after) intermittent hypoxia or sham session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Sep 2022
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intermittent HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a cross-over design study that requires 2 visits (a least 1-week apart). Fifteen younger adults and 15 older adults will be recruited. Participants will be pseudo-randomly assigned to receive either intermittent hypoxia or sham during the first visit, and then switch over to receive sham or intermittent hypoxia during the 2nd visit.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao-Yuan Hsiao, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463042
- Sponsor's protocol ID
- STUDY00003081
- Status last verified
- Nov 2023
- First submitted
- 8 Jul 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This proposed research will include data from approximately 30 subjects regarding their walking and standing balance control mechanics. Muscle activation patterns, body movement, and force production data will be recorded. Only de-identified data will be shared for research purposes.
Publications
Mateika JH, El-Chami M, Shaheen D, and Ivers B. Intermittent hypoxia: a low-risk research tool with therapeutic value in humans. J Appl Physiol (1985). 2015. 118(5): 520-32. Meerson F, Pozharov V, and Minyailenko T. Superresistance against hypoxia after preliminary adaptation to repeated stress. J Appl Physiol (1985). 1994. 76(5): 1856-61. Neubauer JA. Invited review: Physiological and pathophysiological responses to intermittent hypoxia. J Appl Physiol (1985). 2001. 90(4): 1593-9. Casey DP, Shepherd JR, and Joyner MJ. Sex and vasodilator responses to hypoxia at rest and during exercise. J Appl Physiol (1985). 2014. 116(7): 927-36. Casey DP, Walker BG, Curry TB, and Joyner MJ. Ageing reduces the compensatory vasodilatation during hypoxic exercise: the role of nitric oxide. J Physiol. 2011. 589(Pt 6): 1477-88. Jarrard CP, Nagel MJ, Stray-Gundersen S, Tanaka H, and Lalande S. Hypoxic preconditioning attenuates ischemia-reperfusion injury in young healthy adults. J Appl Physiol (1985). 2021. 130(3): 846-852. Nagel MJ, Jarrard CP, and Lalande S. Effect of a Single Session of Intermittent Hypoxia on Erythropoietin and Oxygen-Carrying Capacity. Int J Environ Res Public Health. 2020. 17(19). Wojan F, Stray-Gundersen S, Nagel MJ, and Lalande S. Short exposure to intermittent hypoxia increases erythropoietin levels in healthy individuals. J Appl Physiol (1985). 2021. 130(6): 1955-1960. Wesseling KH, Jansen JR, Settels JJ, and Schreuder JJ. Computation of aortic flow from pressure in humans using a nonlinear, three-element model. J Appl Physiol (1985). 1993. 74(5): 2566-73.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Hypoxia on Balance Control During Standing and Walking in Healthy Adults
- ClinicalTrials.gov ID
- NCT05463042
- Acronym / sponsor ID
- STUDY00003081
- Conditions
- Intermittent Hypoxia, Normoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the effect of acute mild intermittent hypoxia on ankle plantarflexor muscle output during balance regulation and walking in younger and older adults. Fifteen younger adults and 15 older adults will be recruited to participate in the cross-over design study that requires 2 visits (at least 1-week apart). Participants will be pseudo-randomly assigned to receive either intermittent hypoxia or sham during the first visit, and then switch over to receive sham or intermittent hypoxia during the 2nd visit. Muscle activation patterns and kinetic and kinematics during standing and walking will be recorded before and after the intermittent hypoxia/sham. It is hypothesized that compared to the sham condition, both younger and older participants will show greater increases in ankle plantarflexor muscle activation during gait and balance assessments following intermittent hypoxia.
Detailed description
Procedure:
This is a cross-over design study that requires 2 visits (at least 1-week apart). Fifteen younger adults and 15 older adults will be recruited. Participants will be pseudo-randomly assigned to receive either intermittent hypoxia or sham during the first visit, and then switch over to receive sham or intermittent hypoxia during the 2nd visit.
During each visit, participants will first perform Gait and Balance Assessments (PRE), followed by the Intermittent Hypoxia (or sham) protocol, and then perform Gait and Balance Assessments (POST) again. The total time is approximately 2.5 hours for each visit.
Balance and Gait Assessments The consent process and Balance and Gait Assessments will take place in BEL 530.
During Balance and Gait Assessments, participants will be asked to wear tight-fitting shorts and shirt for accurate marker positioning. Approximately 39 reflective markers will be attached to target locations on the individuals' body (the head, arms, wrists, hands, trunk, pelvis, legs and feet) according to the Vicon Full-Body Plug-In Gait Model.
A study team member will attach surface electrodes over the tibialis anterior and soleus muscles to record the muscle activation patterns with a wireless Electromyography (EMG) system (Delsys Inc., Natick, MA). Next, a study team member will assist the participant to wear a safety harness that will be attached to an overhead support beam.
For Balance Assessment, participants will stand on the treadmill with their feet shoulder-width apart. A 30-second quiet standing trial will be recorded. Next, participants will be instructed to maintain upright posture when the treadmill shifts forward or backward at unknown times (perturbed standing). The treadmill will shift approximately 3 cm. Based on our previous experiment, this distance is sufficient to trigger a response without inducing a fall. Three forward and 3 backward treadmill shifts will be delivered in a randomized order. Finally, participants will be asked to close their eyes and repeat the quiet standing and perturbed standing trials. A 10-camera Vicon Nexus motion capture system (Vicon, Oxford Metrics, UK) will be used to record whole body kinematics. Ground reaction forces under each belt will be recorded. A handrail is located on either side of the treadmill.
For Gait Assessments, participants will walk on the treadmill at their comfortable and fast walking speeds. The comfortable speed will be determined by gradually increasing the treadmill speed until the participant confirms that it reaches their comfortable regular walking speed. The fast speed will be determined by gradually increasing the treadmill speed until the participant confirms that it reaches the maximum speed that they can walk safely. A 30-second walking trial will be recorded for each speed.
Following Balance and Gait Assessment, a testing team member will escort the participant to BEL819 Clinical Exercise Physiology Laboratory to perform Intermittent Hypoxia (or sham).
Intermittent hypoxia Intermittent hypoxia will be performed in BEL819 Clinical Exercise Physiology Laboratory. Intermittent hypoxia is routinely performed in this laboratory (IRB protocols 2017090015, 2018110129, 2019070088, and 202005018). Intermittent hypoxia consisting of a limited number (5-10/day) of short (4-10 min) bouts of mild hypoxia (oxygen levels between 10-12%) leads to cumulative and sustained beneficial physiological responses. Preliminary data collected in the Clinical Exercise Physiology Laboratory show that a fraction of oxygen of 11±1% corresponds to an arterial oxygen saturation of 80±2% in middle-aged individuals. Participants will be sitting during the entire breathing protocol. Hypoxic air will be inhaled through a mask connected to a two-way non-rebreathing valve, which will itself be connected to a 5-liter non-diffusing gas bag (Hans Rudolph, Inc, USA). The rebreathing bag will be connected to a certified medical grade gas tank containing 11% oxygen and a balance of nitrogen. The intermittent hypoxia protocol will consist of eight 4-min cycles of breathing hypoxic air interspersed with normoxic cycles breathing room air. After four min of hypoxia, participants will be switched back to breathing room air until resaturation, which takes approximately one minute. Once arterial oxygen saturation reaches baseline levels, participants will be switched back to breathing hypoxic air, beginning the next hypoxic cycle. Unlike chronic hypoxic exposure, risks associated with an acute hypoxic exposure of three 4-min cycles are minimal, and no adverse events were reported during intermittent hypoxia in our participants.
During the sham condition, compressed air (21% oxygen) from a gas tank will be delivered throughout the protocol instead of 11% oxygen. Participants will not receive information about which condition (Intermittent hypoxia or sham) they are experiencing during the trials.
Pulmonary gas exchange Breath-by-breath measures of pulmonary gas exchange such as volume of oxygen and carbon dioxide, respiratory rate, tidal volume, minute ventilation and fraction of inspired oxygen will be determined from a pneumotachometer (Ultima Cardio2, MGC Diagnostics, MN, USA) throughout the intermittent hypoxia. The pneumotachometer will be mounted between the mask and the non-rebreathing valve of the breathing circuit. The pneumotachometer, mouthpiece and non-rebreathing valve will be disinfected in a 10% bleach and water solution for 60 minutes and rinse thoroughly with tap water for 5 minutes between each use. Each participant will have a face mask that will only be used by him/her.
Hemodynamics An arterial waveform obtained by finger plethysmography from the middle finger of the left hand will be continuously recorded (NOVA, Finapres Medical Systems, Amsterdam, Netherlands) during the intermittent hypoxia. Systolic, diastolic and mean arterial pressure, heart rate, stroke volume, cardiac output and total peripheral resistance will be derived from the arterial waveform, a method which has been validated against invasive measures [9]. All data will be recorded in LabChart (Powerlab, ADInstruments Inc., CO, USA) for later analysis.
Arterial oxygen saturation Arterial oxygen saturation will continuously be monitored by pulse oximetry (NOVA, Finapres Medical Systems, Amsterdam, Netherlands) throughout the intermittent hypoxia. The pulse oximeter probe will be applied to the index finger of the left hand.
Following intermittent hypoxia (or sham), a testing team member will escort the participant back to BEL530 to perform Balance and Gait Assessment. After the assessment, a testing team member will remove the electrodes and markers from the participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a cross-over design study that requires 2 visits (a least 1-week apart). Fifteen younger adults and 15 older adults will be recruited. Participants will be pseudo-randomly assigned to receive either intermittent hypoxia or sham during the first visit, and then switch over to receive sham or intermittent hypoxia during the 2nd visit.
| Arm | Type | Receives |
|---|---|---|
| Intermittent Hypoxia | Experimental | Behavioral: Intermittent HypoxiaParticipants will receive intermittent hypoxia and perform balance and gait assessments before and after the intermittent hypoxia session. |
| Normoxia (sham) | Sham comparator | Behavioral: Normoxia (sham)Participants will receive normoxia and perform balance and gait assessments before and after the normoxia session. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Able to stand and walk for more than 5 minutes without assistance.
Key exclusion criteria (9 listed)
- Have high blood pressure (above 130/90 mmHg)
- Are smokers
- Are pregnant
- Have body mass index more than 35 kg/m2
- Have a history of falls in the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent HypoxiaDuring the intermittent hypoxia session, participants will be sitting during the entire breathing protocol. Hypoxic air will be inhaled through a mask connected to a two-way non-rebreathing valve, which will itself be connected to a 5-liter non-diffusing gas bag (Hans Rudolph, Inc, USA). The rebreathing bag will be connected to a certified medical grade gas tank containing 11% oxygen and a balance of nitrogen. The intermittent hypoxia protocol will consist of eight 4-min cycles of breathing hypoxic air interspersed with normoxic cycles breathing room air. After four min of hypoxia, participants will be switched back to breathing room air until resaturation, which takes approximately one minute. Once arterial oxygen saturation reaches baseline levels, participants will be switched back to breathing hypoxic air, beginning the next hypoxic cycle. | Behavioural | Intermittent Hypoxia |
| Normoxia (sham)During the sham condition, compressed air (21% oxygen) from a gas tank will be delivered throughout the protocol instead of 11% oxygen. Participants will not receive information about which condition (Intermittent hypoxia or sham) they are experiencing during the trials. | Behavioural | Normoxia (sham) |
Primary outcome
Soleus muscle activation pattern
Time frame: pre (2o minutes before) and post (20 minutes after) intermittent hypoxia or sham session
changes in peak soleus muscle EMG magnitude following perturbation onset during standing from pre to post intermittent hypoxia will be calculated
Ankle plantarflexion torque
Time frame: pre (20 minutes before) and post (20 minutes after) intermittent hypoxia or sham session
Changes in peak ankle plantarflexion torque production during walking from pre to post intermittent hypoxia will be calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- BackgroundMateika JH, El-Chami M, Shaheen D, and Ivers B. Intermittent hypoxia: a low-risk research tool with therapeutic value in humans. J Appl Physiol (1985). 2015. 118(5): 520-32. Meerson F, Pozharov V, and Minyailenko T. Superresistance against hypoxia after preliminary adaptation to repeated stress. J Appl Physiol (1985). 1994. 76(5): 1856-61. Neubauer JA. Invited review: Physiological and pathophysiological responses to intermittent hypoxia. J Appl Physiol (1985). 2001. 90(4): 1593-9. Casey DP, Shepherd JR, and Joyner MJ. Sex and vasodilator responses to hypoxia at rest and during exercise. J Appl Physiol (1985). 2014. 116(7): 927-36. Casey DP, Walker BG, Curry TB, and Joyner MJ. Ageing reduces the compensatory vasodilatation during hypoxic exercise: the role of nitric oxide. J Physiol. 2011. 589(Pt 6): 1477-88. Jarrard CP, Nagel MJ, Stray-Gundersen S, Tanaka H, and Lalande S. Hypoxic preconditioning attenuates ischemia-reperfusion injury in young healthy adults. J Appl Physiol (1985). 2021. 130(3): 846-852. Nagel MJ, Jarrard CP, and Lalande S. Effect of a Single Session of Intermittent Hypoxia on Erythropoietin and Oxygen-Carrying Capacity. Int J Environ Res Public Health. 2020. 17(19). Wojan F, Stray-Gundersen S, Nagel MJ, and Lalande S. Short exposure to intermittent hypoxia increases erythropoietin levels in healthy individuals. J Appl Physiol (1985). 2021. 130(6): 1955-1960. Wesseling KH, Jansen JR, Settels JJ, and Schreuder JJ. Computation of aortic flow from pressure in humans using a nonlinear, three-element model. J Appl Physiol (1985). 1993. 74(5): 2566-73.
- Individual participant dataSharing planned: Yes. This proposed research will include data from approximately 30 subjects regarding their walking and standing balance control mechanics. Muscle activation patterns, body movement, and force production data will be recorded. Only de-identified data will be shared for research purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Hypoxia in people with Intermittent Hypoxia and Normoxia, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soleus muscle activation pattern (time frame: pre (2o minutes before) and post (20 minutes after) intermittent hypoxia or sham session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05463042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023; AzTrials last refreshed its copy on 31 Oct 2026.