aerSleep II for Obstructive Sleep Apnea

Delta Waves, Colorado Springs, CO
Obstructive Sleep Apnea+1 More ConditionsaerSleep II - Device
18 - No maximum age
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new device to treat sleep apnea in people who can't use CPAP. The device will be used at home for 24 weeks to see if it is safe and effective.

Eligible Conditions
  • Obstructive Sleep Apnea
  • Sleep Apnea

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 24 weeks

24 weeks
AHI change from baseline for all subjects that acclimate to the aerSleep II device
Adverse Device Effects
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
Change in sleep impairment from baseline as measured by PROMIS Sleep Sleep-Related Impairment questionnaire
ODI change
Sustained response to aerSleep II therapy at 24 weeks

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

aerSleep II
1 of 1

Experimental Treatment

900 Total Participants · 1 Treatment Group

Primary Treatment: aerSleep II · No Placebo Group · N/A

aerSleep II
Experimental Group · 1 Intervention: aerSleep II · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: 5 Months
Reporting: 24 weeks

Who is running the clinical trial?

Sommetrics, Inc.Lead Sponsor
6 Previous Clinical Trials
83 Total Patients Enrolled
Kingman P. Strohl, M.D.Principal InvestigatorCase Western Reserve University School of Medicine
1 Previous Clinical Trials

Eligibility Criteria

Age 18 - No maximum age · All Participants · 0 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What site did they apply to?
Baptist Hospital5.9%
University of Arizona5.9%
What portion of applicants met pre-screening criteria?
Met criteria84.2%
Did not meet criteria15.8%
Why did patients apply to this trial?
  • "I would like to try this"
  • "I have OSA, and I tried the CPAP, but could not use it."
  • "I have tried to use CPAP several times can't tolerate it"
  • "I have both obstructive and central apnea (not positive about the central, but can ask my doctor.)"
  • "I have tried CPAP, oral appliance therapy, and UPPP surgery for help with my sleep apnea and it still is unresolved."
How many prior treatments have patients received?
What questions have other patients asked about this trial?
  • "If it is a device and it works , what happens after the trial is over?"

How responsive is this trial?

Typically responds via
Phone Call54.5%
Average response time
  • < 2 Days
Most responsive sites:
  1. BetterNight: < 48 hours

Frequently Asked Questions

To what degree can this research be found in various parts of the state?

"Currently, 16 sites across the country are admitting patients into this study. Residents of Pittsburgh, Little Rock and Columbus can take advantage of nearby locations while other cities provide further options to reduce travel demands for those who partake in the trial." - Anonymous Online Contributor

Unverified Answer

What goals are being pursued with this scientific investigation?

"The primary endpoint of this 24-week clinical trial is to gauge Adverse Device Effects. Secondary endpoints being evaluated include changes in sleep disturbance, as measured by the PROMIS Sleep Disturbance 8b questionnaire; sleep impairment, assessed through the PROMIS Short Form Sleep-Related Impairment 8a Questionnaire; and Oxygen Desaturation Index (ODI) at HST #4 relative to baseline for initial responders." - Anonymous Online Contributor

Unverified Answer

What is the total population size of participants in this clinical trial?

"The study necessitates 250 qualified participants, which can be sourced from UPMC in Pittsburgh, Arkansas and Preferred Research Partners in Little Rock, Ohio." - Anonymous Online Contributor

Unverified Answer

Are any new participants being recruited for this clinical experiment?

" confirms that this trial, originally posted on November 29th 2021, is actively enrolling patients. The study has been edited to reflect new information as recently as November 8th 2022." - Anonymous Online Contributor

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