Negative Pressure Device for Sleep Apnea

(SUPRA Trial)

Recruiting at 15 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

900 Participants Needed

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.

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 data supports the effectiveness of the treatment aerSleep II for sleep apnea?

Research shows that nasal expiratory positive airway pressure (EPAP) devices, similar to aerSleep II, have been effective in treating obstructive sleep apnea by helping keep the airway open during sleep. Studies have demonstrated the long-term effectiveness and safety of these devices in managing sleep apnea symptoms. ^{1 2 3 4 5}

How does the aerSleep II treatment for sleep apnea differ from other treatments?

The aerSleep II treatment is unique because it uses a negative pressure device, which is different from the common positive pressure devices like CPAP (continuous positive airway pressure). This approach may offer a more comfortable alternative by not relying on added pressure to keep airways open during sleep. ^{1 2 6 7 8}

Research Team

Kingman P. Strohl, M.D.

Principal Investigator

Case Western Reserve University School of Medicine

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States 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). [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A crossover study comparing the efficacy of continuous positive airway pressure with anterior mandibular positioning devices on patients with obstructive sleep apnea. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Short and long-term usage of a dental device in sleep apnea syndrome. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

The effect of a mandibular advancement device on apneas and sleep in patients with obstructive sleep apnea. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

A review of EPAP nasal device therapy for obstructive sleep apnea syndrome. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A sleep laboratory evaluation of an automatic positive airway pressure system for treatment of obstructive sleep apnea. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Sleep Apnea Therapy Device Uses No Added Pressure. [2020]