N/A
N=133
Mechanisms of Upper Airway Obstruction
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT04322097 ↗Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Pharyngeal Critical Pressure (Pcrit) — 1.26; -1.42; -1.06 cm H2O — p=.80
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hypoglossal Nerve Stimulation (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharyngeal Critical Pressure (Pcrit) |
1.26; -1.42; -1.06 | .80 |
| PRIMARY Pharyngeal Opening Pressure (PhOP) |
7.99; 7.33; 7.44 | 0.94 |
| PRIMARY Pharyngeal Compliance |
— | — |
Summary
The current study is designed to examine underlying mechanisms of action of lingual muscles in the maintenance of airway patency during sleep. The investigators' major hypothesis is that specific tongue muscles are responsible for relieving upper airway obstruction during sleep.
Eligibility Criteria
Study A Inclusion Criteria:
- Scheduled to undergo DISE as part of routine clinical standard of care.
Study B Inclusion Criteria:
- Adults (≥ 22yrs) willing and capable of providing informed consent
- Implanted with the MRI-conditional Inspire hypoglossal nerve stimulator (Model 3028 or later)
- Compliant with Inspire therapy (> 20 hours/week over 2+ weeks) as a standalone treatment for sleep-disordered breathing
- Inspire remote model 2500 or later.
Study B Exclusion Criteria:
- MRI contraindications (claustrophobia, ferromagnetic implants/foreign bodies, etc.)
- Inspire Implant Model 3024
- Inspire Remote Model 3032
- Patients who have fallen asleep while during resulting in an accident or "near miss" accident within 1 year prior to device implantation.
- Inability to sleep in the supine position (by self-report)
- History of severe difficulty initiating or maintaining sleep in the laboratory
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT04322097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.