Obstructive Sleep Apnea
Conditions
Brief summary
The aim of this study is to examine a new method of device configuration for the Inspire upper airway stimulator. First, the investigators will attempt to determine optimal configuration by quantifying changes in upper airway size with different implant configurations using awake nasal endoscopy. The configuration/voltage that results in the greatest increase in upper airway size and is tolerated by the patient will be selected. Participants will then undergo a sleep study so that increased airway size may be correlated with changes in sleep study parameters including AHI and oxygen desaturation index (ODI). Airway size and sleep study parameters using the standard device configuration (+-+)/voltage will be compared to airway size and sleep study parameters using the test, or optimal, configuration/voltage to determine the usefulness of awake endoscopy in activation of the Inspire device.
Interventions
DIAGNOSTIC_TESTAwake endoscopy
Awake endoscopic exam will be performed to measure airway size in the retropalatal and retroglossal upper airway regions using different Inspire implant configurations and voltages. The optimal test configuration determined on endoscopy will be tested during a sleep study and compared to the standard-of-care device configuration, with improvements in sleep study outcomes indicating that awake endoscopy is useful during Inspire implant activation.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with moderate to severe OSA who have undergone Inspire UAS implantation by the principal investigator * Must have symptoms of OSA prior to Inspire implantation * AHI between 15 and 65, where central and mixed apnea is 25% or more, and the level of collapse is in the soft palate area BMI less than 32 * Age 18 or above
Exclusion criteria
* Significant central sleep apnea * Presence of other sleep disorders * History of neurologic or neuromuscular disease * Historical or present substance abuse * Bleeding disorders * Autoimmune diseases that increase risk of nasal trauma such as Wegener's, Sarcoidosis, etc. * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects | One month after surgical implantation of UAS | The hypoglossal nerve stimulator has a triode (three electrodes) that is wrapped around the nerve. Each electrode can be configured to either Off, Positive, or Negative. For each electrode configuration we determined the percentage of patients with the greatest retropalatal cross-sectional area resulting from stimulation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Awake Endoscopic Examination Subjects who underwent upper airway stimulation (UAS) implantation were recruited for a prospective single-arm cohort study during UAS device activation. Functional thresholds were recorded for all settings. Awake nasopharyngoscopy was performed to examine the retropalatal (RP) and retroglossal (RG) regions at rest and during activation at five different electrode configurations at their functional thresholds. Electrode configurations included: +-+, ---, -o-, o-o, and -+-. Cross-sectional measurements were made by two blinded reviewers and reported as percent change in airway size. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Awake Endoscopic Examination |
|---|---|
| Age, Continuous | 66.1 years STANDARD_DEVIATION 6.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects
The hypoglossal nerve stimulator has a triode (three electrodes) that is wrapped around the nerve. Each electrode can be configured to either Off, Positive, or Negative. For each electrode configuration we determined the percentage of patients with the greatest retropalatal cross-sectional area resulting from stimulation.
Time frame: One month after surgical implantation of UAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Awake Endoscopic Exam | Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects | Positive, Negative, Positive (+-+) | 7 Participants |
| Awake Endoscopic Exam | Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects | Negative, Negative, Negative (---) | 3 Participants |
| Awake Endoscopic Exam | Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects | Off, Negative, Off (o-o) | 3 Participants |
| Awake Endoscopic Exam | Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects | Negative, Off, Negative (-o-) | 2 Participants |
| Awake Endoscopic Exam | Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects | Negative, Positive, Negative (-+-) | 1 Participants |