Spinal Cord InjuriesNCT02973438

Effects of Intermittent Hypoxia (IH) on Metabolism and Dysglycemia, in Overweight/Obese Persons SCI

A study testing Intermittent Hypoxia (IH) in people with Spinal Cord Injuries and Obesity, run by University of Miami at 1 site 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

The purpose of this research is to examine changes in blood glucose control and metabolism in individuals with SCI and non injured controls at rest and during exercise after five days of exposure to IH. This response will be compared with breathing normal room air (a SHAM control). Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Spinal Cord Injuries, Obesity, Insulin Resistance
What is being tested?: Intermittent Hypoxia (IH)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Dec 2016to Dec 2018
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

SCI only:
Lower extremity weakness or paralysis at C5 or below resulting from spinal cord injury for at least one year.
ASIA Classification A-D Overweight or obese as classified by a Body Mass Index (BMI) (kg/m2) of ≥ 25.0 (CON) and ≥ 22.0 (SCI).
SCI and non injured control:
Resting SaO2 ≥ 95%

Who cannot join

Currently hospitalized
Resting heart rate ≥120 BPM
Resting systolic blood pressure >180 mm Hg
Resting diastolic Blood Pressure >100 mmHg
Self-reported history of unstable angina or myocardial infarction within the previous month
Previous cardiac surgery or condition that evidences ischemic heart disease
Cardiopulmonary complication such as COPD
Pregnancy determined by urine testing in sexually active females.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Miami Project to Cure Paralysis
Miami, Florida, 33136

Other trials in United States

About this study

Official title: Effects of Acute Intermittent Hypoxia (AIH) on Metabolism and Dysglycemia, in Overweight/Obese Persons With Spinal Cord Injuries (SCI)

Conditions: Spinal Cord Injuries, Obesity, Insulin Resistance
Being tested: Intermittent Hypoxia (IH), SHAM
Keywords: Spinal Cord Injuries, Obesity, Insulin Resistance, Intermittent hypoxia
Medical subject headings: Spinal Cord Injuries, Obesity, Insulin Resistance

What participants receive

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

Intermittent Hypoxia (IH)Device
Also called Hypoxico
Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.
SHAMDevice
Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).

Study groups in NCT02973438
Study group	Role	What they receive
Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM	Experimental	This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions. Receives: Device: Intermittent Hypoxia (IH); Device: SHAM
Control (CON) Intermittent Hypoxia then SHAM	Experimental	This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions. Receives: Device: Intermittent Hypoxia (IH); Device: SHAM
Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia	Experimental	This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions. Receives: Device: Intermittent Hypoxia (IH); Device: SHAM
Control (CON) SHAM then Intermittent Hypoxia	Experimental	This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions. Receives: Device: Intermittent Hypoxia (IH); Device: SHAM

What is being measured

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

Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR)
Insulin resistance was estimated by the Homeostasis Model Assessment of Insulin Resistance (HOMA2-IR), which is based on fasting glucose and insulin measurements. Values of > 1.8 were considered insulin resistant.
Measured: Baseline, day 5

Secondary outcomes (1)

Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test
Change in exercise substrate partitioning as measured via endurance-maximal oxygen consumption (VO2peak test) and will be reported as change in carbohydrate oxidation (% of total energy expenditure).
Measured: Baseline, day 5

Timeline

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

Dec 2016Dec 2018

First posted25 Nov 2016 (estimated)
Study startDec 2016
Primary completionDec 2018
Study completionDec 2018

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.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
More trials run by University of MiamiThe 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: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02973438
Sponsor's protocol ID: 20160818
Status last verified: Nov 2020
First submitted: 18 Nov 2016
Last updated: 17 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Acute Intermittent Hypoxia (AIH) on Metabolism and Dysglycemia, in Overweight/Obese Persons With Spinal Cord Injuries (SCI)
ClinicalTrials.gov ID: NCT02973438
Acronym / sponsor ID: 20160818
Conditions: Spinal Cord Injuries, Obesity, Insulin Resistance
Keywords: Spinal Cord Injuries, Obesity, Insulin Resistance, Intermittent hypoxia
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Study start: Dec 2016 (actual)
Primary completion: Dec 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 25 Nov 2016 (estimated)
Results: Posted 17 Dec 2020

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM	Experimental	Device: Intermittent Hypoxia (IH), Device: SHAMThis arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
Control (CON) Intermittent Hypoxia then SHAM	Experimental	Device: Intermittent Hypoxia (IH), Device: SHAMThis arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia	Experimental	Device: Intermittent Hypoxia (IH), Device: SHAMThis arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
Control (CON) SHAM then Intermittent Hypoxia	Experimental	Device: Intermittent Hypoxia (IH), Device: SHAMThis arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Lower extremity weakness or paralysis at C5 or below resulting from spinal cord injury for at least one year.
ASIA Classification A-D Overweight or obese as classified by a Body Mass Index (BMI) (kg/m2) of ≥ 25.0 (CON) and ≥ 22.0 (SCI).
Resting SaO2 ≥ 95%

Key exclusion criteria (8 listed)

Currently hospitalized
Resting heart rate ≥120 BPM
Resting systolic blood pressure >180 mm Hg
Resting diastolic Blood Pressure >100 mmHg
Self-reported history of unstable angina or myocardial infarction within the previous month

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 Hypoxia (IH)Also: HypoxicoAdministered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.	Device	Control (CON) Intermittent Hypoxia then SHAM, Control (CON) SHAM then Intermittent Hypoxia, Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM, Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia
SHAMAdministered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).	Device	Control (CON) Intermittent Hypoxia then SHAM, Control (CON) SHAM then Intermittent Hypoxia, Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM, Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia

Primary outcome

Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR)
Time frame: Baseline, day 5
Insulin resistance was estimated by the Homeostasis Model Assessment of Insulin Resistance (HOMA2-IR), which is based on fasting glucose and insulin measurements. Values of > 1.8 were considered insulin resistant.

1 secondary outcome

Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test
Time frame: Baseline, day 5

Results and safety

Results posted to the registry on 17 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spinal Cord Injury (SCI) Intermittent Hypoxia Then SHAM	2	2
Control (CON) Intermittent Hypoxia Then SHAM	1	1
Spinal Cord Injury (SCI) SHAM Then Intermittent Hypoxia	2	2
Control (CON) SHAM Then Intermittent Hypoxia	1	1

Primary outcome: Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR)

Time frame: Baseline, day 5. Mean (Standard Deviation). Unit: IR Score

Measure	Spinal Cord Injury (SCI) Intermittent Hypoxia n = 2	Control (CON) Intermittent Hypoxia n = 0	Spinal Cord Injury (SCI) SHAM n = 2	Control (CON) SHAM n = 0
Value	1.67 (0.91)	–	1.60 (1.27)	–

Population analysed: Unable to obtain blood samples from 2 participants in the control group and 1 participant withdrew prior to the baseline laboratory trial and therefore did not receive any intervention, therefore there is no reported data for the control group.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 29 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spinal Cord Injury (SCI) Intermittent Hypoxia	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Control (CON) Intermittent Hypoxia	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Spinal Cord Injury (SCI) SHAM	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Control (CON) SHAM.	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Mark S Nash, PhD principal investigator

University of Miami

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 (IH) in people with Spinal Cord Injuries and Obesity, run by University of Miami 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 5 inclusion and 8 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 17 Dec 2020. 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. 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 17 Dec 2020). 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 Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR) (time frame: Baseline, day 5). 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 NCT02973438.

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 17 Dec 2020.