What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea (OSA) that serve as alternatives to CPAP, such as oral appliances and pharmacotherapy, have various side effects. Oral appliances can cause jaw discomfort, dental misalignment, and excessive salivation. Pharmacotherapy, including medications like atomoxetine and antimuscarinics, may lead to side effects such as dry mouth, urinary retention, and potential cardiovascular effects. Non-CPAP devices like the aerSleep® II, which use negative pressure to maintain airway patency, are still under study, but potential side effects could include skin irritation and discomfort from the device interface.

What prior FDA approvals exist?

The FDA has approved several treatments for Obstructive Sleep Apnea (OSA), primarily focusing on maintaining airway patency. Continuous Positive Airway Pressure (CPAP) therapy is the most common and well-established treatment. Additionally, oral appliances, such as mandibular advancement devices, have been approved and are used as alternatives to CPAP. These devices reposition the lower jaw to keep the airway open. The aerSleep® II device, currently under study, represents an innovative approach using negative pressure to maintain airway patency, offering an alternative for patients intolerant to CPAP therapy.

What other types of research exist?

Promising novel alternatives to the aerSleep® II device for OSA patients include: 1) Hypoglossal cranial nerve upper airway stimulation (UAS), which has shown positive 36-month outcomes in clinical trials. 2) Intraoral negative air pressure device (iNAP), which has demonstrated efficacy and safety in clinical studies. 3) A novel implantable device, which has shown preliminary feasibility and safety in a multicenter study. These alternatives offer new options for patients who are intolerant of CPAP therapy.

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Negative Pressure Device

Negative Pressure Device for Sleep Apnea (SUPRA Trial)

N/A

Waitlist Available

Led By Kingman P. Strohl, M.D.

Research Sponsored by Sommetrics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years old

Must not have

Known sleep disorder other than OSA, such as narcolepsy, restless leg syndrome, idiopathic hypersomnolence or chronic insomnia

Craniofacial abnormalities that may be contributing to OSA

Timeline

Screening 3 days

Treatment 5 months

Follow Up 3 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the aerSleep® II device, which helps people with sleep apnea breathe better at night. It targets adults who can't use the usual CPAP therapy. The device works by keeping the airway open during sleep.

Who is the study for?

Adults over 18 with a BMI ≤42 kg/m2 who have moderate to severe Obstructive Sleep Apnea (AHI 15 - 50/hour) and are intolerant of CPAP therapy. Participants must not have used CPAP or oral appliances for at least a week before the study, be able to use smart devices, and read/write English. Exclusions include previous neck surgeries, oxygen use, other sleep disorders, certain heart conditions, drug abuse history, psychiatric illness not well-controlled by treatment.

What is being tested?

The aerSleep II device is being tested for its safety and effectiveness in treating Obstructive Sleep Apnea over a period of 24 weeks. The trial involves adults who can't tolerate standard CPAP therapy using this new device at home to see if it improves their condition.

What are the potential side effects?

While specific side effects are not listed here, potential issues could arise from wearing the aerSleep II device such as skin irritation where the collar is placed or discomfort due to fit. It's important that participants report any adverse reactions they experience during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a sleep disorder that is not obstructive sleep apnea.

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I have facial abnormalities that might be causing my sleep apnea.

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I am willing to shave my neck area if it has excessive hair for this study.

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I do not have serious lung problems like severe asthma.

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I do not have serious heart conditions like heart failure or unstable heart disease.

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I have had surgery or a procedure on my neck or heart arteries, or I have a severe narrowing in my neck arteries.

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I have had surgery for a condition affecting the blood flow in my limbs.

Timeline

Screening ~ 3 days1 visit

Treatment ~ 5 months4 visits

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ 5 months

Follow Up ~3 days

This trial's timeline: 3 days for screening, 5 months for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Device Effects

Sustained response to aerSleep II therapy at 24 weeks

Secondary study objectives

AHI change from baseline for all subjects that acclimate to the aerSleep II device

Change in sleep disturbance from baseline as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance questionnaire

Change in sleep from baseline as measured by Patient Global Impression Scale questionnaire

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: aerSleep IIExperimental Treatment1 Intervention

Use of aerSleep II device to provide continuous external negative pressure to treat moderate to severe OSA in spontaneously breathing subjects who are intolerant of CPAP

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Obstructive Sleep Apnea (OSA) is Continuous Positive Airway Pressure (CPAP) therapy, which works by delivering a constant stream of air through a mask to keep the airway open during sleep. This prevents the airway from collapsing, thereby reducing apneas and improving sleep quality. Alternative methods, such as the aerSleep® II device, use negative pressure to achieve a similar effect by creating a vacuum that helps keep the airway open. Maintaining airway patency is crucial for OSA patients as it prevents interruptions in breathing, reduces daytime sleepiness, and lowers the risk of cardiovascular complications associated with untreated OSA.

Treatment of Obstructive Sleep Apnea. Prospects for Personalized Combined Modality Therapy.Pharmacological treatment of sleep apnea: current situation and future strategies.