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Device

AIH Therapy for Spinal Cord Injury

N/A
Recruiting
Led By Shirin Shafazand, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cervical injury (C5-C8)
Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 1 post aih, baseline to day 3 post aih, baseline to day 10, baseline to day 17
Awards & highlights

Study Summary

This trial will test the effects of sleep apnea and low oxygen on muscle strength and lung function in people with chronic spinal cord injury.

Who is the study for?
This trial is for adults over 18 with chronic, non-progressive spinal cord injury (SCI) at least one year post-injury. Participants must have an Asia Impairment Scale of C or D, a cervical injury between C5-C8, and normal oxygen levels. It's not for hospitalized individuals, those with recent heart issues, pregnant women, prisoners, people unable to consent or currently on airway pressure therapy for sleep apnea.Check my eligibility
What is being tested?
The study investigates the effects of induced low oxygen conditions using an AIH mask on muscle strength and lung function in individuals with chronic SCI. The intervention mimics sleep apnea to understand its impact on motor abilities.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the AIH mask and symptoms related to low oxygen like shortness of breath or dizziness during the treatment sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an injury between the C5 and C8 vertebrae in my neck.
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I am 18 years old or older.
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My spinal cord injury is over a year old and not getting worse.
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I have partial control over my limbs after a spinal injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The difference in Motor Function assessed via hand grip strength measured by electromyographic (EMG) recordings between participants with moderate to severe OSA and without OSA.
The difference in Motor Function assessed via hand grip strength measured by maximum grip strength (MGS) between participants with moderate to severe OSA and without OSA.
Secondary outcome measures
Change in Motor Function assessed via hand grip strength measured by EMG recordings.
Change in Motor Function assessed via hand grip strength measured by MGS.
Change in biomarker levels

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Moderate to Severe Obstructive Sleep Apnea (OSA)Experimental Treatment2 Interventions
Individuals with moderate to severe OSA defined as having an Apnea-hypopnea Index (AHI) that is greater than or equal to 15.
Group II: Without OSAActive Control2 Interventions
Individuals without OSA defined as having AHI less than 5.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
901 Previous Clinical Trials
409,956 Total Patients Enrolled
The Craig H. Neilsen FoundationOTHER
55 Previous Clinical Trials
2,905 Total Patients Enrolled
Shirin Shafazand, MDPrincipal Investigator - University of Miami
Anne Bates Leach Eye Hospital Bascom Palmer Eye Institute, Holtz Children's Hospital, Jackson Memorial Hospital, Univ of Miami Hosp & Clinics-Sylvester Comp Cancer Center, University of Miami Medicine
University Of Toronto (Medical School)
Stanford University Hospital (Residency)

Media Library

AIH mask (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04017767 — N/A
Obstructive Sleep Apnea Research Study Groups: Without OSA, Moderate to Severe Obstructive Sleep Apnea (OSA)
Obstructive Sleep Apnea Clinical Trial 2023: AIH mask Highlights & Side Effects. Trial Name: NCT04017767 — N/A
AIH mask (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04017767 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for participants in this scientific trial?

"According to the clinicaltrials.gov repository, this medical trial is presently enrolling patients and was initially advertised on July 16th 2021 with its most recent edit done August 29th 2022."

Answered by AI

To what extent is the number of participants limited in this research endeavor?

"Affirmative. The clinical trial's page on the clinicaltrials.gov website shows that recruitment is still taking place, having been launched on July 16th 2021 and last edited August 29th 2022. They are seeking 30 qualified candidates from one site in particular."

Answered by AI

What are the main goals of this experiment?

"This medical trial aims to evaluate the difference in Pulmonary Function as measured by Maximum Inspiratory Pressure (MIP) between participants with moderate to severe Obstructive Sleep apnea (OSA) and those without OSA. Secondary outcomes include Change in Motor Function assessed via hand grip strength recorded through Electromyography (EMG), alteration of biomarker levels including Brain-Derived Neurotrophic Factor (BDNF) and Vascular Endothelial Growth Factor (VEGF), as well as changes in Lung Capacity evaluated through Forced Vital Capacity tests."

Answered by AI

Who else is applying?

What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Motor Plasticity, Intermittent Hypoxia and Sleep Apnea
Shirin Shafazand 2021. "Motor Plasticity, Intermittent Hypoxia and Sleep Apnea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04017767.
All > Apnea > Sleep Apnea
~2 spots leftby Jul 2024
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