Delayed enhancement magnetic resonance imaging (DE-MRI) for Sleep Apnea, Obstructive

Phase-Based Estimates
1
Effectiveness
1
Safety
Tulane University Medical Center, New Orleans, LA
Sleep Apnea, Obstructive+5 More
Delayed enhancement magnetic resonance imaging (DE-MRI) - Device
Eligibility
18+
All Sexes
Eligible conditions
Sleep Apnea, Obstructive

Study Summary

Atrial Fibrosis Progression in Sleep Apnea Patients: A Pilot Study

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Eligible Conditions

  • Sleep Apnea, Obstructive
  • Apnea
  • Atrial Fibrillation
  • Fibrosis
  • Sleep Apnea Syndromes
  • Obstructive Sleep Apnea (OSA)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Delayed enhancement magnetic resonance imaging (DE-MRI) will improve 1 primary outcome and 1 secondary outcome in patients with Sleep Apnea, Obstructive. Measurement will happen over the course of From baseline to 6 months.

Baseline, 6 months
Percent change of atrial fibrosis measured by DE-MRI
Month 6
The occurrence of arrhythmia

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Experimental group

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) 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.

Experimental group
Device
The group will include 15 patients with OSA 5 with mild OSA 5 with moderate OSA 5 with severe OSA
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 6 months for reporting.

Closest Location

Tulane University Medical Center - New Orleans, LA

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:
18-75-year-old,
With mild to severe OSA (mild: Apnea Hypopnea Index: AHI between 5-15, Moderate AHI= 15-30, severe AHI>30), diagnosed by polysomnography.
Patient with a creatinine measurement within the last 6 months.
Control group (5 patients): patients with no lung or heart disease, matched by age and BMI.
Experimental group: (15 patients)

Patient Q&A Section

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

What causes sleep apnea, obstructive?

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sleep apnea, obstructive, can adversely affect daytime and night-time HRV, as well as cause cardiovascular, cognitive, and psychological problems. The latter can be improved with CPAP correction of sleep apnea.

Unverified Answer

How many people get sleep apnea, obstructive a year in the United States?

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Approximately 5 million Americans get obstructive [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea), and about 4.8 million have severe sleep apnea. These numbers suggest that sleep apnea is an increasingly important problem. More research is needed to determine the exact prevalence of these conditions among different types of sleep disorders, and to identify modifiable risk factors and interventions that will reduce the burden of sleep apnea.

Unverified Answer

What is sleep apnea, obstructive?

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Sleep apnea is a medical syndrome that often affects otherwise healthy preteen children. Sleep apnea may be a risk factor of developing sleep related breathing disorders like obstructive sleep apnea hypopnea, central sleep apnea, or upper airway resistant breathing. It's important for doctors to identify children with sleep apnea and ensure that proper patient care measures will be instituted so that it will be treated earlier than necessary.

Unverified Answer

What are common treatments for sleep apnea, obstructive?

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Some patients with obstructive [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) benefit from a continuous positive airway pressure (CPAP) device. Others benefit from other therapies such as avoidance of triggers for obstructive episodes and lifestyle improvements. There are no medications for sleep apnea, so medical therapy has not been standardized. In general, no one type of treatment is best for all patients with sleep apnea because it is a very variable, often chronic condition. However, many patients and families prefer self-management. Sleep apnea, obstructive is typically the most common sleep-disordered breathing that patients seek treatment for in primary care.

Unverified Answer

What are the signs of sleep apnea, obstructive?

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Most clinicians lack the ability to differentiate patients who screen positive for sleep apnea on the basis of signs and symptoms alone. The use of polysomnography or pulse oximetry may be helpful in the evaluation of these patients, and in the management of patients with sleep apnea.

Unverified Answer

Can sleep apnea, obstructive be cured?

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Obstructive sleep apnea cannot be cured. Most patients with obstructive sleep apnea should not be treated. They can, however, be improved by treatment of factors related to their sleep apnea, such as weight loss and medication.

Unverified Answer

What is the average age someone gets sleep apnea, obstructive?

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The average age of people with OSA are much higher than what patients think, which suggests a great need for early diagnosis and treatment in those [over the age of 55] who are at risk for OSA.

Unverified Answer

Have there been any new discoveries for treating sleep apnea, obstructive?

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Since 1998, the treatment of sleep apnea has become better and more effective. The use of continuous positive airway pressure (CPAP) therapy has improved patient compliance tremendously. However, CPAP may not be an ideal therapy for everyone because only 45% of patients improved dramatically.

Unverified Answer

What is the primary cause of sleep apnea, obstructive?

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Obstructive [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) mainly occurred in obese subjects, smoking and alcohol use, in the population with sleep-related breathing disorder, and in the elderly group with neurological illness. Therefore, it is important to assess the sleep apnea with the objective way.

Unverified Answer

What are the common side effects of delayed enhancement magnetic resonance imaging (de-mri)?

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Patients undergoing de-mri scans are at risk, not only for the acute, immediate, pain and adverse reactions to the scan, but also for the side effects of the MR contrast injected. The risk is greatest for younger patients, those with multiple and prior adverse reactions and those with an unstable clinical picture.

Unverified Answer

Is delayed enhancement magnetic resonance imaging (de-mri) typically used in combination with any other treatments?

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This imaging modality has a place in assessing patients with suspected obstructive sleep apnea (OSA), as a complement to a clinical history and physical examination. It can, therefore, identify the presence of OSA in some patients. At this time, it is not known whether DE-MRI could replace PSA for surveillance in patients receiving continuous positive airway pressure (CPAP). Given its simplicity, relative expense, and ease of availability, it would be ideal for clinical trials looking at the effect of CPAP on brain structures.

Unverified Answer

Does sleep apnea, obstructive run in families?

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Overall, the data suggest that there is no evidence of an association between sleep apnea and obstructive sleep apnea syndrome/Central sleep apnea in offspring and that any causal relationship between the two is likely to be minimal.

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