AIH mask for Anoxia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, Miami, FL
Anoxia+4 More
AIH mask - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether sleep apnea and low oxygen levels may be contributing to muscle weakness and lung problems in individuals with spinal cord injury.

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Eligible Conditions

  • Anoxia
  • Spinal Cord Injuries
  • Sleep Apnea, Obstructive

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether AIH mask will improve 4 primary outcomes and 5 secondary outcomes in patients with Anoxia. Measurement will happen over the course of Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17.

Baseline
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.
The difference in Pulmonary Function assessed via Forced Vital Capacity (FVC) between participants with moderate to severe OSA and without OSA.
The difference in Pulmonary Function assessed via Maximum Inspiratory Pressure (MIP) between participants with moderate to severe OSA and without OSA.
Day 17
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 Pulmonary Function assessed by MIP
Change in Pulmonary Function assessed via FVC
Change in biomarker levels

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Without OSA
1 of 2
Moderate to Severe Obstructive Sleep Apnea (OSA)
1 of 2
Active Control
Experimental Treatment

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. AIH Mask is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Moderate to Severe Obstructive Sleep Apnea (OSA)Individuals with moderate to severe OSA defined as having an Apnea-hypopnea Index (AHI) that is greater than or equal to 15.
Without OSAIndividuals without OSA defined as having AHI less than 5.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline for reporting.

Who is running the study

Principal Investigator
S. S.
Prof. Shirin Shafazand, Professor
University of Miami

Closest Location

University of Miami - Miami, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient has a C5-C8 cervical spine injury. show original
Age 18 or older
Chronic (≥ 1-year post-injury), non-progressive SCI
The Asia Impairment Scale (AIS) is a measure of how impaired an individual is in Asia show original
Resting Saturated oxygen (SaO2) ≥ 95%

Patient Q&A Section

Is aih mask typically used in combination with any other treatments?

"The high price and accessibility of the aih mask as well as the relatively low number of patients with AHD treated with it prompted this investigation." - Anonymous Online Contributor

Unverified Answer

How many people get spinal cord injuries a year in the United States?

"The present findings provide the first detailed overview of US SCI. The findings indicate that more people get SCI annually than previously thought, and that SCI rates in some geographic areas are about threefold higher than in others. Furthermore, the rate varies among states and regions but remains low (0.1 per 100,000 population). While the precise causes of SCI remain to be determined, the incidence could be substantially reduced if the proportion of people using safety devices were improved and the rate of cycling among children and youth was substantially increased." - Anonymous Online Contributor

Unverified Answer

What is spinal cord injuries?

"SCI can change health-related quality of life. It can affect people in a wide range of areas such as physical, mental, social, and economic functioning. It may affect a person's ability to perform normal everyday activities. SCI is one of the most common kinds of trauma, which may injure, wound, or cut the spinal cord. This injury may result in paralysis, loss or alteration of sensation, and decreased function. It is the leading cause of paralysis worldwide, and contributes to a large part of the burden of disability.\n\nAccording to the study, there are 12 specific locations that affect how healthy the body becomes. One way to avoid contracting SCI is to adopt healthy lifestyles." - Anonymous Online Contributor

Unverified Answer

What causes spinal cord injuries?

"Spinal cord injuries can occur from various causes, including sudden mechanical injury, a drug overdose or chemical exposure or a direct gunshot blast. When a gunshot blast causes one's head to be positioned below the torso, a serious [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) can result if the victim loses the ability to elevate the head. Spinal cord injuries often occur in one or multiple areas of the spine because of the many nerves, the vessels and the spinal cord crossing the spine at many different locations around the lower back. The injuries to the nerves and vessels supplying the legs may also occur together with other spinal cord injuries." - Anonymous Online Contributor

Unverified Answer

Can spinal cord injuries be cured?

"Most neurologists and patients think that the future is bleak. However, in rarer circumstances, there are still treatment options for this condition. New treatments are tested through clinical studies, and they are very small, with very limited power and few patients. However, [with the right conditions and people(https://support.power.com/courses/how-power-helpers-run-a-study/courses-and-treatments)], studies can be started to test an expensive new treatment option that is tested for 30 patients to see if it has a positive effect on the condition of the patients." - Anonymous Online Contributor

Unverified Answer

What are common treatments for spinal cord injuries?

"Most SCI do not require treatment. However, in cases of more severe SCI, prompt medical treatment and management of associated conditions accelerate recovery. In addition, a variety of treatments may be performed for some cases of SCI, including surgeries to relieve pressure, relieve pain, or control a problem such as pressure sores. SCI patients also may receive rehabilitation to help them regain function and return to the activities of daily living. The treatment of SCI is based on the degree and location of loss of function from the injury. The aim is to obtain the best possible care as the person's SCI progresses." - Anonymous Online Contributor

Unverified Answer

What are the signs of spinal cord injuries?

"Signs of a [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) are inconsistent, yet non-specific and difficult to identify, especially when comparing the neurologically intact person and patient with a spinal cord injury. There is a wide range of signs between different spinal cord injuries." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving aih mask?

"We recommend that further studies be implemented on the safety of MHs, comparing adverse events against other surgical interventions such as SCI, especially when there are no previous clinical trials or high quality studies regarding this topic." - Anonymous Online Contributor

Unverified Answer

How serious can spinal cord injuries be?

"SCI can drastically change a person’s life, often in a short time frame. The severity of an SCI may depend on several factors, but there are certain signs and symptoms that warrant a medical professional’s attention.\n\nSCI is often irreversible; however, the severity of an accident or trauma does not necessarily represent how severe an SCI could potentially have been." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating spinal cord injuries?

"With all the new discoveries found and the efforts made in curing spinal cord injuries, it is important to revisit the medical and surgical treatment of spinal cord injuries, as well as what has happened in terms of therapies and surgeries in the past 50 years or so. By revisiting and repeating these old discoveries, it may be more successful in the curing and recovery of spinal cord injuries." - Anonymous Online Contributor

Unverified Answer

What is aih mask?

"The aih mask is a mask with a small airway which is designed to be a comfortable piece of headwear, worn by people with an incomplete spinal cord injury, specifically those with complete injury. We believe it to be a useful way of facilitating the work of the care team in managing head posture. Additional research needs to be undertaken to assess the practical use of the device. This trial was registered in the Australian and New Zealand Clinical Trials Registry (ACTRN 1260400109818)." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets spinal cord injuries?

"[Due to the high percentage of youth that may be exposed to a [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury), clinicians may want to consider screening all adolescents for potential spinal cord injuries. See "Spinal Cord" below for more information. As you look at any injuries associated with a spinal cord injury, the number in the table illustrates the overall incidence of the disease in the US population (or the adult US population). A spinal cord injury is one of the most severe spinal cord injuries. As shown below, the total number of people that have had a spinal cord injury is steadily increasing. [Power](http://www.withpower." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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