Clinical trial NCT03359096: Hypoglossal Nerve Stimulation on Cardiovascular Outcomes
Official title: Cardiovascular Endpoints for Obstructive Sleep Apnea With Twelfth Nerve Stimulation (CARDIOSA-12): A Randomized, Sham-Controlled, Double-Blind, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Sleep apnea
Tongue stimulation
Cardiovascular function
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: American Academy of Sleep Medicine
First posted: 2017-12-02
Enrollment: 63
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Washout Period 1 (Study Week 1): The patient will not use Hypoglossal Nerve Stimulation (HGNS) for 1 week. Randomization Visit (Study Week 2): The patient will be randomized to sub-therapeutic HGNS (sham) or therapeutic HGNS (treatment) for 28 days. Sympathetic and Vascular testing (Study Week 6). Washout Period 2 (Study Week 6-7): The patient will not use HGNS for 7 days. The patient will be switched to the other intervention arm (treatment to sham vs. sham to treatment) for 28 days. Sympathetic and Vascular testing (Study Week 11).
Primary purpose: TREATMENT

Brief 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.

Detailed description: Obstructive sleep apnea, repetitive airway blockage during sleep, affects 1 in 10 Americans. If left untreated, it results in decreased quality of life and increased risk of heart problems. Only half of these people are able to use the main treatment, continuous positive airway pressure (CPAP) therapy, which involves wearing a mask and hose at night. A new, well-tolerated treatment - 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.

Primary outcomes:
measure: Mean 24-Hour Systolic Ambulatory Blood Pressure Values
timeFrame: Study Week 6, Day 1; study Week 11, Day 1
Secondary outcomes:
measure: Mean 24-Hour Diastolic Ambulatory Blood Pressure Values
timeFrame: Study Week 6, Day 1; study Week 11, Day 1
measure: Mean Nocturnal Systolic and Diastolic Ambulatory Blood Pressure Values
timeFrame: Study Week 6, Day 1; study Week 11, Day 1
measure: Mean Muscle Sympathetic Nerve Activity (MSNA) Frequency (Bursts/Minute)
timeFrame: Study Week 6, Day 2; Study Week 11, Day 2
measure: Mean Muscle Sympathetic Nerve Activity (MSNA) Tonal Activity (Units/Minute)
timeFrame: Study Week 6, Day 2; Study Week 11, Day 2
measure: Mean Pre-Ejection Period (PEP)
timeFrame: Study Week 6, Day 2; Study Week 11, Day 2
measure: Mean Flow-mediated Dilation (FMD)
timeFrame: Study Week 6, Day 2; Study Week 11, Day 2
measure: Mean Peripheral Arterial Stiffness (PAS)
timeFrame: Study Week 6, Day 2; Study Week 11, Day 2
measure: Mean Psychomotor Vigilance Test (PVT) Reciprocal Reaction Time
timeFrame: Study Week 6, Day 2; Study Week 11, Day 2
measure: Mean Digit Symbol Substitution Test (DSST) Reaction Time
timeFrame: Study Week 6, Day 2; Study Week 11, Day 2
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Raj C Dedhia, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dedhia RC, Quyyumi AA, Park J, Shah AJ, Strollo PJ, Bliwise DL. Cardiovascular endpoints for obstructive sleep apnea with twelfth cranial nerve stimulation (CARDIOSA-12): Rationale and methods. Laryngoscope. 2018 Nov;128(11):2635-2643. doi: 10.1002/lary.27284. Epub 2018 Sep 8.