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.
- Obstructive Sleep Apnea
- Sleep Apnea
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 5 Secondary · Reporting Duration: 24 weeks
Trial Safety
Phase-Based Safety
Awards & Highlights
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - No maximum age · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| California | 71.4% |
| Florida | 9.5% |
| Pennsylvania | 4.8% |
| Other | 14.3% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Baptist Hospital | 5.9% |
| University of Arizona | 5.9% |
| BetterNight | 76.5% |
| Other | 11.8% |
What portion of applicants met pre-screening criteria?
| Met criteria | 84.2% |
| Did not meet criteria | 15.8% |
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?
| 0 | 35.7% |
| 1 | 28.6% |
| 2 | 28.6% |
| 3+ | 7.1% |
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 Call | 54.5% |
| 45.5% | |
Average response time
- < 2 Days
Most responsive sites:
- 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
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
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
Are any new participants being recruited for this clinical experiment?
"Clinicaltrials.gov 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