Spinal Cord InjuriesNCT03071393

Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury

A study testing Hypoxia via Hypoxico Hyp-123 in people with Spinal Cord Injuries, run by University of Florida at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Spinal Cord Injuries
What is being tested?: Hypoxia via Hypoxico Hyp-123
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 2 sitesUnited States
Study dates: 10 Jul 2017to 1 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, ages 18-65
Greater than 6 months post-spinal cord injury
Spinal cord injury affecting segments between C4-T12
No other known neurological disorders
Able to provide informed consent
no severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments.

Who cannot join

Presence of a self-reported uncontrolled medical condition including, but not limited to: cardiovascular disease; sleep apnea; obstructive lung disease; severe neuropathic or chronic pain; severe recurrent autonomic dysreflexia
Severe, untreated bladder or urinary tract infection
Presence of severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments
Women who report being pregnant or test positive on a pregnancy test

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Florida
Gainesville, Florida, 32611
Brooks Rehabilitation
Jacksonville, Florida, 32216

Other trials in United States

About this study

Official title: Acute Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury

This study will examine if acute intermittent hypoxia (brief episodes of breathing lower oxygen), which has been shown to enhance plasticity and motor output, can enhance functional outcomes and muscle activation in individuals with spinal cord injury. Our aim is to assess breathing, sitting, standing and walking functional ability before and after acute intermittent hypoxia, compared to a sham treatment. This information may be useful in advancing rehabilitation for people with spinal cord injuries.

Read the detailed description

Recent evidence has shown that acute intermittent hypoxia can strengthen motor pathways after spinal cord injury, and enhance walking outcomes after walking rehabilitation compared to walking rehabilitation alone. A single session of acute intermittent hypoxia has also been shown to temporarily enhance breathing and limb strength in people with spinal cord injury. Further evidence supports the hypothesis that acute intermittent hypoxia acts on all motor pathways, and thus can enhance the strength of most muscles in the body.

Spinal cord injury affects the muscles that control respiration. Decreased respiratory muscle function can lead to diseases of the respiratory system, which are the primary cause of death and significant cause of re-hospitalization after spinal cord injury. Deficits in postural muscle function affect one's ability to balance, safely maintain a seated position, or ambulate after spinal cord injury, severely impacting daily activities such as self-care and feeding skills.

This study will test the hypothesis that a single session of acute intermittent hypoxia will increase strength and activation of the muscles that control respiration and posture, leading to improved scores on functional assessments in individuals with chronic spinal cord injury. Our long term goal is to better understand the therapeutic potential of acute intermittent hypoxia combined with physical rehabilitation for individuals with chronic spinal cord injury.

Conditions: Spinal Cord Injuries
Being tested: Hypoxia via Hypoxico Hyp-123, Sham via Hypoxico Hyp-123
Keywords: acute intermittent hypoxia, breathing, spinal cord injury, motor function
Medical subject headings: Spinal Cord Injuries, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hypoxia via Hypoxico Hyp-123Device
Also called Altitude Generator
During acute intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of low oxygen air (9-15% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.
Sham via Hypoxico Hyp-123Device
Also called Altitude Generator
During sham intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of normal oxygen air (21% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.

Study groups in NCT03071393
Study group	Role	What they receive
Acute Intermittent Hypoxia, then Sham Intermittent Hypoxia	Experimental	Subjects with chronic spinal cord injury first received an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen). After a washout period of at least one week, they then received sham intermittent hypoxia with normal oxygen air (21% inspired oxygen). Receives: Device: Hypoxia via Hypoxico Hyp-123; Device: Sham via Hypoxico Hyp-123
Sham Intermittent Hypoxia, then Acute Intermittent Hypoxia	Experimental	Subjects with chronic spinal cord injury first received a sham (placebo) intermittent hypoxia protocol with normal oxygen air (21% inspired oxygen). After a washout period of at least one week, they then received an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen). Receives: Device: Hypoxia via Hypoxico Hyp-123; Device: Sham via Hypoxico Hyp-123

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Maximal Inspiratory Pressure
An assessment of inspiratory muscle strength.
Measured: Change between baseline and 30 minutes post-intermittent hypoxia or sham.
Change in Maximal Expiratory Pressure
An assessment of expiratory muscle strength.
Measured: Change between baseline and 30 minutes post-intermittent hypoxia or sham.
Change in Forced Vital Capacity
An assessment of how much air a person can forcefully exhale after a maximal inspiratory effort.
Measured: Change between baseline and 30 minutes post-intermittent hypoxia or sham.
Change in Mouth Occlusion Pressure (P0.1)
An assessment of the pressure generated in the first 0.1 seconds of the participant's initiation of inhalation.
Measured: Change between baseline and 30 minutes post-intermittent hypoxia or sham.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 20171 Sep 2020

First posted6 Mar 2017
Study start10 Jul 2017
Primary completion1 Sep 2020
Study completion1 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
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
Masking: Single blind
Who is masked: Participant
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03071393
Sponsor's protocol ID: IRB201601680
Status last verified: Dec 2021
First submitted: 20 Feb 2017
Last updated: 18 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Gonzalez-Rothi EJ, Lee KZ, Dale EA, Reier PJ, Mitchell GS, Fuller DD. Intermittent hypoxia and neurorehabilitation. J Appl Physiol (1985). 2015 Dec 15;119(12):1455-65. doi: 10.1152/japplphysiol.00235.2015. Epub 2015 May 21.
PubMed 25997947
Hayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27.
PubMed 24285617
Trumbower RD, Jayaraman A, Mitchell GS, Rymer WZ. Exposure to acute intermittent hypoxia augments somatic motor function in humans with incomplete spinal cord injury. Neurorehabil Neural Repair. 2012 Feb;26(2):163-72. doi: 10.1177/1545968311412055. Epub 2011 Aug 5.
PubMed 21821826
Tester NJ, Fuller DD, Fromm JS, Spiess MR, Behrman AL, Mateika JH. Long-term facilitation of ventilation in humans with chronic spinal cord injury. Am J Respir Crit Care Med. 2014 Jan 1;189(1):57-65. doi: 10.1164/rccm.201305-0848OC.
PubMed 24224903
Satriotomo I, Nichols NL, Dale EA, Emery AT, Dahlberg JM, Mitchell GS. Repetitive acute intermittent hypoxia increases growth/neurotrophic factor expression in non-respiratory motor neurons. Neuroscience. 2016 May 13;322:479-88. doi: 10.1016/j.neuroscience.2016.02.060. Epub 2016 Mar 2.
PubMed 26944605
Sutor T, Cavka K, Vose AK, Welch JF, Davenport P, Fuller DD, Mitchell GS, Fox EJ. Single-session effects of acute intermittent hypoxia on breathing function after human spinal cord injury. Exp Neurol. 2021 Aug;342:113735. doi: 10.1016/j.expneurol.2021.113735. Epub 2021 May 2.
PubMed 33951477

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury
ClinicalTrials.gov ID: NCT03071393
Acronym / sponsor ID: IRB201601680
Conditions: Spinal Cord Injuries
Keywords: acute intermittent hypoxia, breathing, spinal cord injury, motor function
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Study start: 10 Jul 2017 (actual)
Primary completion: 1 Sep 2020 (actual)
Study completion: 1 Sep 2020 (actual)
First posted: 6 Mar 2017 (actual)
Results: Posted 18 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Acute Intermittent Hypoxia, then Sham Intermittent Hypoxia	Experimental	Device: Hypoxia via Hypoxico Hyp-123, Device: Sham via Hypoxico Hyp-123Subjects with chronic spinal cord injury first received an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen). After a washout period of at least one week, they then received sham intermittent hypoxia with normal oxygen air (21% inspired oxygen).
Sham Intermittent Hypoxia, then Acute Intermittent Hypoxia	Experimental	Device: Hypoxia via Hypoxico Hyp-123, Device: Sham via Hypoxico Hyp-123Subjects with chronic spinal cord injury first received a sham (placebo) intermittent hypoxia protocol with normal oxygen air (21% inspired oxygen). After a washout period of at least one week, they then received an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male or female, ages 18-65
Greater than 6 months post-spinal cord injury
Spinal cord injury affecting segments between C4-T12
No other known neurological disorders
Able to provide informed consent

Key exclusion criteria (4 listed)

Presence of a self-reported uncontrolled medical condition including, but not limited to: cardiovascular disease; sleep apnea; obstructive lung disease; severe neuropathic or chronic pain; severe recurrent autonomic dysreflexia
Severe, untreated bladder or urinary tract infection
Presence of severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments
Women who report being pregnant or test positive on a pregnancy test

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
Hypoxia via Hypoxico Hyp-123Also: Altitude GeneratorDuring acute intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of low oxygen air (9-15% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.	Device	Acute Intermittent Hypoxia, then Sham Intermittent Hypoxia, Sham Intermittent Hypoxia, then Acute Intermittent Hypoxia
Sham via Hypoxico Hyp-123Also: Altitude GeneratorDuring sham intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of normal oxygen air (21% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.	Device	Acute Intermittent Hypoxia, then Sham Intermittent Hypoxia, Sham Intermittent Hypoxia, then Acute Intermittent Hypoxia

Primary outcome

Change in Maximal Inspiratory Pressure
Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.
An assessment of inspiratory muscle strength.
Change in Maximal Expiratory Pressure
Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.
An assessment of expiratory muscle strength.
Change in Forced Vital Capacity
Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.
An assessment of how much air a person can forcefully exhale after a maximal inspiratory effort.
Change in Mouth Occlusion Pressure (P0.1)
Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.
An assessment of the pressure generated in the first 0.1 seconds of the participant's initiation of inhalation.

Results and safety

Results posted to the registry on 18 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acute Intermittent Hypoxia, Then Sham Intermittent Hypoxia	7	7
Sham Intermittent Hypoxia, Then Acute Intermittent Hypoxia	10	10

Primary outcome: Change in Maximal Inspiratory Pressure

Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.. Mean (Standard Deviation). Unit: cmH2O

Measure	All Study Participants - Acute Intermittent Hypoxia n = 17	All Study Participants - Sham n = 17
Value	8.2 (12.3)	-3.0 (11.3)

All Study Participants - Acute Intermittent Hypoxia vs All Study Participants - Sham: p <0.05, Wilcoxon (Mann-Whitney)

Population analysed: All participants completed the measure and were analyzed

Primary outcome: Change in Maximal Expiratory Pressure

Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.. Mean (Standard Deviation). Unit: cmH2O

Measure	All Study Participants - Acute Intermittent Hypoxia n = 17	All Study Participants - Sham n = 17
Value	4.3 (11.5)	2.9 (9.8)

All Study Participants - Acute Intermittent Hypoxia vs All Study Participants - Sham: p <0.05, Wilcoxon (Mann-Whitney)

Population analysed: All participants completed the measure and were analyzed

Primary outcome: Change in Forced Vital Capacity

Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.. Mean (Standard Deviation). Unit: Liters

Measure	All Study Participants - Acute Intermittent Hypoxia n = 14	All Study Participants - Sham n = 14
Value	-0.01 (0.17)	0.00 (0.21)

All Study Participants - Acute Intermittent Hypoxia vs All Study Participants - Sham: p <0.05, ANOVA

Population analysed: The measure was not obtained on 3 participants

Primary outcome: Change in Mouth Occlusion Pressure (P0.1)

Time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.. Mean (Standard Deviation). Unit: cmH2O

Measure	All Study Participants - Acute Intermittent Hypoxia n = 12	All Study Participants - Sham n = 12
Value	0.24 (0.30)	0.15 (0.50)

All Study Participants - Acute Intermittent Hypoxia vs All Study Participants - Sham: p <0.05, Wilcoxon (Mann-Whitney)

Population analysed: This measure was obtained in 12 participants. 12 participants were analyzed.

Adverse events

Time frame: 3 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acute Intermittent Hypoxia	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Sham Intermittent Hypoxia	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25997947Gonzalez-Rothi EJ, Lee KZ, Dale EA, Reier PJ, Mitchell GS, Fuller DD. Intermittent hypoxia and neurorehabilitation. J Appl Physiol (1985). 2015 Dec 15;119(12):1455-65. doi: 10.1152/japplphysiol.00235.2015. Epub 2015 May 21.
Background: PubMed 24285617Hayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27.
Background: PubMed 21821826Trumbower RD, Jayaraman A, Mitchell GS, Rymer WZ. Exposure to acute intermittent hypoxia augments somatic motor function in humans with incomplete spinal cord injury. Neurorehabil Neural Repair. 2012 Feb;26(2):163-72. doi: 10.1177/1545968311412055. Epub 2011 Aug 5.
Background: PubMed 24224903Tester NJ, Fuller DD, Fromm JS, Spiess MR, Behrman AL, Mateika JH. Long-term facilitation of ventilation in humans with chronic spinal cord injury. Am J Respir Crit Care Med. 2014 Jan 1;189(1):57-65. doi: 10.1164/rccm.201305-0848OC.
Background: PubMed 26944605Satriotomo I, Nichols NL, Dale EA, Emery AT, Dahlberg JM, Mitchell GS. Repetitive acute intermittent hypoxia increases growth/neurotrophic factor expression in non-respiratory motor neurons. Neuroscience. 2016 May 13;322:479-88. doi: 10.1016/j.neuroscience.2016.02.060. Epub 2016 Mar 2.
Results publication: PubMed 33951477Sutor T, Cavka K, Vose AK, Welch JF, Davenport P, Fuller DD, Mitchell GS, Fox EJ. Single-session effects of acute intermittent hypoxia on breathing function after human spinal cord injury. Exp Neurol. 2021 Aug;342:113735. doi: 10.1016/j.expneurol.2021.113735. Epub 2021 May 2.
Individual participant dataSharing planned: No

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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.

Emily J Fox, MHS, DPT, PhD principal investigator

University of Florida

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hypoxia via Hypoxico Hyp-123 in people with Spinal Cord Injuries, run by University of Florida at 2 sites 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 6 inclusion and 4 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 18 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 2 sites 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. 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?

Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Maximal Inspiratory Pressure (time frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.). The study lists 4 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 NCT03071393, which also lists 6 linked publications.

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 18 Nov 2023.