Negative Pressure Device for Sleep Apnea

(SUPRA Trial)

Not currently recruiting at 16 trial locations

Overseen By Richard Bogan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sommetrics, Inc.

Disqualifiers: Narcolepsy, Insomnia, Pulmonary, Cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, aerSleep II, for individuals with moderate to severe Obstructive Sleep Apnea (OSA) who find traditional CPAP machines uncomfortable or difficult to use. The goal is to determine if this device, which uses gentle suction around the neck to keep airways open, is safe and effective over 24 weeks of home use. Ideal participants are adults diagnosed with OSA, who have tried CPAP without success, and can manage a smartphone or tablet.

As an unphased trial, this study provides a unique opportunity to explore an innovative treatment option for OSA.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that you do not use CPAP or oral appliances during the study.

What prior data suggests that the aerSleep II device is safe for treating sleep apnea?

Research has shown that aerSleep II could be a good option for people with sleep apnea who can't use CPAP machines. In earlier studies, 70% of patients found aerSleep comfortable for long-term use, indicating ease of use for many. Additionally, 88% of patients reported a better experience with this device compared to other treatments. While these results are positive, treatments can work differently for everyone. However, these numbers suggest that most users tolerate aerSleep II well, and no major safety issues have been reported in the available data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for obstructive sleep apnea (OSA) involve Continuous Positive Airway Pressure (CPAP) devices, which can be cumbersome and uncomfortable for many users. The aerSleep II device stands out because it offers a novel approach by using continuous external negative pressure to keep the airway open during sleep. This method can be more comfortable and less intrusive, especially for those who find CPAP intolerable. Researchers are excited about aerSleep II because it may improve adherence and comfort for users, potentially leading to better long-term management of OSA.

What evidence suggests that the aerSleep II device is effective for treating Obstructive Sleep Apnea?

Research has shown that the aerSleep II device could be a promising new treatment for sleep apnea. This device improves nighttime breathing through gentle suction. Early results suggest it might be especially useful for those who struggle with CPAP, a common sleep apnea treatment. The trial aims to evaluate the aerSleep II device's effectiveness in reducing the frequency of breathing interruptions during sleep. While the researchers continue to assess its efficacy, the focus remains on improving sleep quality and easing symptoms for individuals with moderate to severe sleep apnea. ^{2 3 4 5 6}

Who Is on the Research Team?

Kingman P. Strohl, M.D.

Principal Investigator

Case Western Reserve University School of Medicine

Are You a Good Fit for This Trial?

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

Able to speak, read, and write English

is required People must have a prior diagnosis of OSA in order to be eligible for this study

Body mass index ≤42 kg/m2

Exclusion Criteria

You have a mental health condition that is not being effectively managed with treatment, as determined by the study investigator.

I do not have serious lung problems like severe asthma.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Acclimation

Participants undergo a 1-week acclimation period with the aerSleep II device at home

1 week

Home use

Treatment

Participants use the aerSleep II device at home for 24 weeks, with interim assessments

24 weeks

Home use with interim home sleep studies

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• aerSleep II

Trial Overview 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.

How Is the Trial Designed?

Group I: aerSleep II Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Sommetrics, Inc.

Lead Sponsor

Trials

7

Recruited

980+

Published Research Related to This Trial

The nasal expiratory positive airway pressure (EPAP) device significantly reduced the apnea-hypopnea index (AHI) from 15.7 to 4.7 events per hour after 12 months of treatment, indicating effective long-term management of obstructive sleep apnea (OSA).

Patients reported a 74.4% reduction in snoring and a significant decrease in daytime sleepiness, as measured by the Epworth Sleepiness Scale, demonstrating both efficacy and improved quality of life with excellent adherence to the device (89.3% of nights used).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). Kryger, MH., Berry, RB., Massie, CA.[2021]

EPAP nasal devices are a promising treatment for obstructive sleep apnea (OSA), showing a reduction in the apnea/hypopnea index (AHI) and daytime sleepiness, with patients generally preferring them over CPAP.

While CPAP is more effective for improving sleep apnea, EPAP can provide similar symptom relief for patients with mild to moderate OSA who cannot tolerate CPAP, although more well-designed clinical trials are needed to fully assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of EPAP nasal device therapy for obstructive sleep apnea syndrome. Wu, H., Yuan, X., Zhan, X., et al.[2021]

The anterior mandibular positioning (AMP) device significantly reduced the apnea-hypopnea index (AHI) in patients with obstructive sleep apnea, showing a decrease from 35.6 to 22.7 after two weeks of use, and maintained a lower AHI of 25.3 after one year.

The device was well tolerated by 76% of patients over a year, with no long-term issues related to dental health or jaw function, although 29% discontinued use due to TMJ pain or unsatisfactory results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short and long-term usage of a dental device in sleep apnea syndrome. Peled, E., Yoffe, N., Blumenfeld, I., et al.[2009]

The study of 44 patients with varying degrees of obstructive sleep apnea showed that using a mandibular advancement device significantly reduced the number of apneas, with the obstructive apnea-hypopnea index decreasing from 11 to 5 in mild cases, 27 to 7 in moderate cases, and 53 to 14 in severe cases, indicating its efficacy across all severity levels.

The device not only reduced apneas but also improved overall sleep quality, with 28 out of 44 patients achieving a successful treatment outcome, particularly in those with mild and moderate sleep apnea, highlighting the importance of follow-up assessments to monitor for potential silent apneas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a mandibular advancement device on apneas and sleep in patients with obstructive sleep apnea. Marklund, M., Franklin, KA., Sahlin, C., et al.[2019]

Citations

1. sommetrics.com sommetrics.com/sommetrics-launches-pivotal-clinical-study-raises-11-million-series-c/

Sommetrics Launches Pivotal Clinical Study of Its aerSleep ... Sommetrics Launches Pivotal Clinical Study of Its aerSleep II Product to Treat Sleep Apnea; Raises $11 Million in Series C Preferred Financing.

2. withpower.com withpower.com/trial/phase-sleep-apnea-syndromes-8-2021-0619e

Negative Pressure Device for Sleep Apnea (SUPRA 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.

3. ctv.veeva.com ctv.veeva.com/study/study-using-negative-pressure-to-reduce-apnea

Study Using Negative Pressure to Reduce Apnea (SUPRA) The objective of this study is to determine the safety and effectiveness of the aerSleep® II device for treatment of moderate to severe ...

4. clinicaltrial.be clinicaltrial.be/fr/details/44662?per_page=100&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Study Using Negative Pressure to Reduce Apnea (SUPRA) The primary effectiveness endpoint is to demonstrate that a majority of adult subjects who are initial responders to aerSleep II therapy ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10566235/

Comparative outcomes in obstructive sleep apnea therapy The results of this large retrospective study suggest an at least comparable effectiveness of CPAP and multilevel surgery for OSA [16]. With 69 ...

6. sommetrics.com sommetrics.com/aersleep/

aerSleep 70% of patients stated that aerSleep would be acceptable for long-term treatment of their sleep apnea. · 88% of patients stated their experience was better ...