Active for Obstructive Sleep Apnea

Phase-Based Progress Estimates
Morton Plant Mease Health Care, Safety Harbor, FLObstructive Sleep Apnea+4 MoreHypoglossal Nerve Stimulation - Device
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new system to help people with sleep apnea who can't or don't want to use positive airway pressure treatment.

Eligible Conditions
  • Obstructive Sleep Apnea
  • Sleep Apnea
  • Sleep Hypopnea

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Month 1 through Month 7

Baseline through Month 7
Change in CGI-S/CGI-I (Efficacy)
Change in EQ-5D (Efficacy)
Change in Epworth Sleepiness Scale (Efficacy)
Change in Functional Outcomes of Sleep Questionnaire (Efficacy
Change in PROMIS SDI/SRI (Efficacy)
Change in SF-36 (Efficacy)
Change in SF-36/SF-6 (Efficacy)
Decrease in Oxygen Desaturation Index (Efficacy)
Consent through Month 7
Descriptive analysis of all reported Adverse Events (Safety)
Month 7
Rate of all serious adverse device/procedure related events from time of implant through month 7
Rate of response to therapy when compared to no therapy for 6 months

Trial Safety

Trial Design

1 Treatment Group

1 of 1

Active Control

150 Total Participants · 1 Treatment Group

Primary Treatment: Active · No Placebo Group · N/A

ActiveComparator Group · 1 Intervention: Hypoglossal Nerve Stimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: month 1 through month 7

Who is running the clinical trial?

LivaNovaLead Sponsor
62 Previous Clinical Trials
34,519 Total Patients Enrolled
Atul Malhotra, MDPrincipal InvestigatorUCSD Pulmonary and Critical Care Medicine
11 Previous Clinical Trials
815 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You refuse to use or cannot tolerate PAP (positive airway pressure) therapy.
You have a moderate to severe form of sleep apnea.

Who else is applying?

What state do they live in?
South Carolina50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Bogan Sleep Consultants, Llc33.3%
University of Utah33.3%
Epic Medical Research33.3%
What portion of applicants met pre-screening criteria?
Met criteria75.0%
Did not meet criteria25.0%
Why did patients apply to this trial?
  • "I have sleep apnea and on a cpap looking for alternative."

Frequently Asked Questions

To what extent is the capacity of this experiment being tested?

"Affirmative. On, it can be confirmed that this medical research is actively recruiting volunteers; the trial was initially launched on July 27th 2021 and last changed on November 14th 2022. 150 participants need to join from 20 distinct sites of care." - Anonymous Online Contributor

Unverified Answer

Is this research endeavor accepting new participants at the present time?

"This research is actively enrolling patients, as indicated by the most recent information posted on This trial was first posted to this website on July 27th 2021 and has since seen amendments up until November 14th 2022." - Anonymous Online Contributor

Unverified Answer

How many sites have been selected to conduct this clinical experiment?

"There are 20 clinical trial sites currently participating in this research endeavour, located in Louisville, Lincoln and Roseville as well as 17 other places. To minimize travel stressors for participants, selecting the closest location is recommended if you choose to join." - 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.