Negative Pressure Device for Sleep Apnea
(SUPRA Trial)

Recruiting in Palo Alto (17 mi)

+15 other locations

Overseen ByKingman P. Strohl, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sommetrics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

Exclusion Criteria

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

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

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

I do not have serious lung problems like severe asthma.

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

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

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

Participant Groups

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.

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