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Nerve stimulation implant for obstructive sleep apnea with full airway collapse

Tests a tongue nerve stimulator in adults with obstructive sleep apnea.

Key facts

Who runs it
Brigham and Women's Hospital
Where
Boston, United StatesSee the 2 sites
Trial code
Registry title
Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea With Complete Concentric Collapse
Status
Not yet recruiting
People taking part
20 people, planned
Starts
1 Dec 2026
Expected to end
1 Jun 2031
Type of study
Interventional
Treatments tested
  • Inspire Hypoglossal Nerve Stimulation System
Record updated
27 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate to severe obstructive sleep apnea whose airway closes from all sides at the soft palate during sleep. They will receive an Inspire nerve stimulation implant.

Age
18 years or older
Sex
All sexes
Disease stage
Obstructive sleep apnea with an apnea-hypopnea index (AHI) of 15 events/hour or more, confirmed by an overnight sleep study in a lab. The airway must close fully from all sides at the soft palate (complete concentric collapse), seen on a sleep endoscopy done under medicine-induced sleep. The care team must otherwise consider the person able to have the implant.
Earlier treatment
CPAP must have failed or not been tolerated before. People who already had a hypoglossal nerve stimulation implant cannot join.

Main reasons for not taking part

  • Reasons the implant would be unsafe or not appropriate
  • Central or mixed sleep apnea making up more than 25% of all breathing events
  • Unstable or uncontrolled medical conditions
  • Unable to safely have overnight sleep studies or other study tests
  • Pregnancy

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Age ≥18 years
  • Diagnosis of obstructive sleep apnea with an apnea-hypopnea index (AHI) ≥15 events/hour, confirmed by attended in-laboratory polysomnography (PSG) before enrollment and implantation
  • Complete concentric collapse (CCC) of the soft palate on clinically obtained drug-induced sleep endoscopy (DISE)
  • Otherwise considered an appropriate candidate for HGNS implantation by the treating surgical and sleep medicine team, aside from CCC status
  • Prior CPAP failure or intolerance, consistent with usual HGNS candidacy evaluation
  • Ability to provide informed consent
  • Willingness to undergo investigational HGNS implantation and required follow-up procedures under the research protocol

Who cannot take part

  • Prior HGNS implantation
  • Contraindications to HGNS implantation or conditions that, in the judgment of the treating clinicians or investigators, make investigational HGNS use unsafe or inappropriate
  • Any unstable or uncontrolled medical condition that, in the judgment of the investigator, would increase procedural risk or interfere with study participation
  • Central or mixed sleep apnea comprising >25% of total respiratory events
  • Inability to safely undergo study procedures, including overnight sleep studies or physiological monitoring
  • Pregnancy

Where in United States

  • Brigham and Women's HospitalBoston, United StatesContact: Daniel Vena, PhDNot yet recruiting
  • Massachusetts Eye and EarBoston, United StatesContact: Daniel Vena, PhDNot yet recruiting

About the trial

What the trial wants to find out

This study examines how hypoglossal nerve stimulation affects breathing and sleep apnea in adults whose airway closes from all sides at the soft palate during sleep, a pattern called complete concentric collapse. Participants will receive an Inspire hypoglossal nerve stimulation implant and undergo sleep studies, questionnaires, and home monitoring. This use of the device is investigational. The study will measure changes in airway collapsibility, sleep apnea severity, device use, and safety through 12 months after implantation.

The group in the trial

  • Investigational HGNS in CCCTreatment being tested

    Adults with complete concentric collapse receive Inspire HGNS implantation, activation, titration, and follow-up, with physiological testing and safety assessments through 12 months after implantation.

    Treatment: Inspire Hypoglossal Nerve Stimulation System

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Physiological and Anatomical Determinants of Hypoglossal Nerve Stimulation Outcomes in Complete Concentric Collapse Investigational Cohort
Plain-language title
Nerve stimulation implant for obstructive sleep apnea with full airway collapseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
27 October 2026