N/A
N=63
Hypoglossal Nerve Stimulation on Cardiovascular Outcomes
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT03359096 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Mean 24-Hour Systolic Ambulatory Blood Pressure Values — 122.8; 123.0 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Therapeutic HGNS (Device); Subtherapeutic 'Sham' HGNS (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean 24-Hour Systolic Ambulatory Blood Pressure Values |
122.8; 123.0 | — |
| SECONDARY Mean 24-Hour Diastolic Ambulatory Blood Pressure Values |
71.9; 72.1 | — |
| SECONDARY Mean Nocturnal Systolic and Diastolic Ambulatory Blood Pressure Values |
115.0; 114.8; 65.8; 66.3 | — |
| SECONDARY Mean Muscle Sympathetic Nerve Activity (MSNA) Frequency (Bursts/Minute) |
20.2; 17.6 | — |
| SECONDARY Mean Muscle Sympathetic Nerve Activity (MSNA) Tonal Activity (Units/Minute) |
29.6; 7.0 | — |
| SECONDARY Mean Pre-Ejection Period (PEP) |
105.7; 105.4 | — |
| SECONDARY Mean Flow-mediated Dilation (FMD) |
6.65; 6.79 | — |
| SECONDARY Mean Peripheral Arterial Stiffness (PAS) |
11.1; 9.8 | — |
| SECONDARY Mean Psychomotor Vigilance Test (PVT) Reciprocal Reaction Time |
4.01; 3.97 | — |
| SECONDARY Mean Digit Symbol Substitution Test (DSST) Reaction Time |
1846.64; 1893.57 | — |
Summary
A new, well-tolerated treatment for obstructive sleep apnea - tongue stimulation - is a device which opens the airway during sleep and can provide treatment for patients unable to use the mask and hose treatment. The study will evaluate the effect of this new treatment on blood pressure and heart-related measures to see if it lowers patients' risk of heart problems.
Eligibility Criteria
All patients recruited into the study will have already been implanted with the Inspire® HGNS device.
Additional Inclusion Criteria include:
- As tolerating the therapeutic level during sleep can take time (weeks to months), all patients must be able to use the device at the therapeutic setting (> 20 hours/week for > 1 month) prior to enrollment, based on compliance data.
- All patients will be English-speaking and able to give written informed consent.
Exclusion Criteria include:
- Inspire® remote Model 2500 or later is required. Patients with older remotes are not candidates due to limited adherence monitoring capabilities.
- Patients who have fallen asleep while driving resulting in accident or "near miss" accident within 1 year prior to HGNS implantation.
- Actively using positive airway pressure (PAP) therapy for treatment of OSA.
- Patients in whom the difference between sham and therapeutic voltages is less than 30% the therapeutic voltage.
- Pregnant women will be excluded.*
- Women of childbearing potential must NOT be pregnant or plan on becoming pregnant. This study involves temporarily stopping treatment of obstructive sleep apnea, which may harm the fetus. If applicable, the patient will need to take a urine pregnancy test after enrollment (prior to washout #1), and again prior to washout #2.
Data sourced from ClinicalTrials.gov (NCT03359096). 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.