Dr. Ruchir P. Patel, a sleep medicine specialist at The Insomnia and Sleep Institute of Arizona in Phoenix, AZ, and a member of the Inspire Excellence Program discusses what Inspire therapy is and how it works to treat obstructive sleep apnea (OSA).

1. Inspire:
an alternative to
CPAP therapy
Ruchir P. Patel, M.D.
Medical Director, The Insomnia and Sleep Institute of Arizona

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3. Obstructive Sleep Apnea (OSA)
• Tongue and Soft Palate Relax
During Sleep And Block Airflow
• Over 20 Million Americans Have
Moderate to Severe (OSA)
84% 74%
Apnea Episode 1
47 seconds
Apnea Episode 2
86 seconds
Blood
Oxygen
Level
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4. Health Risks of Untreated OSA
Fatigue, Diminished Productivity
Accident Risk – Community Safety
Snoring – Bed Partner
Heart and Brain Health
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5. CPAP – The Gold Standard
for treating OSA
• CPAP therapy provides excellent results for
treating OSA and symptomatic improvements
when used regularly and comfortably.
• However, CPAP can be challenging for some
individuals to adapt and/or acclimate to using
regularly and some cannot tolerate it at all.
• The risks of untreated OSA, however, are quite
severe and thus the challenge for us as sleep
physicians is how to successfully treat this
group of patients that have quite significant
OSA but cannot tolerate CPAP therapy.
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6. Alternate Treatment Options
• Oral Appliances are custom dentist-made
mouthpieces intended to advance the jaw
forward during sleep
• Yet, not very effective in treating individuals that have
more severe OSA
• Risks of TMJ discomfort and bite changes
• Upper airway surgery to remove parts of the
jaw, tongue, or throat to create a larger airway
• Yet, upper airway surgery is not recommended as a
primary treatment for OSA
• Can be painful
• OSA and snoring often persist
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7. Inspire Therapy
A Treatment for Obstructive Sleep Apnea
Patients Who Are Unable to Use CPAP
• Hypoglossal nerve stimulator
• Activates the hypoglossal nerve
(nerve that controls the tongue) to
move the tongue forward with each
breath
• The implant prevents the throat
from collapsing with each breath
while you sleep
• Safe outpatient procedure
• Performed by ENT
• Fast recovery time
• The implant is activated and
managed by your sleep physician
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8. Safe outpatient procedure
• Inserted through 2 small 2” (5cm) incisions
• Recovery post-operatively is fast
• OTC pain meds for post-operative pain
• Can return to non-strenuous activity within
a few days after surgery
• ~11-year battery life
• MRI of the head, neck, and extremities can be
safely performed
• System tracks treatment adherence
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9. How Does it Work?
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10. Hypoglossal Nerve Stimulation Effect
No Stimulation Mild Stimulation
Base of Tongue Palate Base of Tongue Palate
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11. Inspire Eligibility Requirements
Adults 18 years of age
and older
Diagnosed with
Moderate to Severe
OSA (AHI 15-65)
CPAP failure or
inability to tolerate
CPAP
Appropriate airway
anatomy & < 25%
Central/Mixed sleep apnea
Inspire is not for everyone. Risks associated with the surgical implant procedure may include infection and temporary tongue weakness. Some patients may require post implant
adjustments to the system’s settings in order to improve effectiveness and ease any initial discomfort they may experience. Important safety information and product manuals can be found
at inspiresleep.com/safety-information/, or call 1-844-OSA-HELP.
BMI must be < 35 kg/m2
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12. Inspire Care Pathway
Activation:
Daytime
Clinic Visit
Fine-Tuning:
Sleep Study
Long-Term
Care
Management
Endoscopy
(DISE) &
Inspire
Procedure
Patient
Screening
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13. Activation: Office Visit
1. Determine and establish initial
settings
• Comfortable
• Effective
• Observe tongue movement
2. Teach the patient how to use the
Inspire remote
3. Review self-titration protocol
4. Review follow-up office visit
schedule
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14. Sleep Study to Confirm
Amplitude Level
• Approximately 3 months after the
Inspire implant was placed a sleep
study will be performed
• Goal of the sleep study to is to
determine the exact amplitude
(voltage setting) that needs to be used
to treat the OSA
• Follow up after the sleep study
• Review the sleep study results
• Adjust settings on the implant if
needed
• Routine follow up thereafter
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15. Growing Adoption
Most US Insurance Covers Inspire
• Broad private insurance coverage - ~85%
national approval rate
• Medicare coverage across the US
• Many VA and military hospitals
• Over 100 Peer-Reviewed Publications
• 5-Year Follow-Up Data; STAR Trial
• Enrollment goal of 5,000 pts in ADHERE Registry
Sustained Clinical Results
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16. STAR Trial Overview: 5-Year Follow-Up Complete
Strollo et al NEJM 2014; Woodson et al
Heise et al ERJ 2019
Pietzsch et Marin; 2018;
29.3
9.0
6.0 6.2
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
Baseline 1-Year 3-Year 5-Year
Median
AHI
(events/hour)
11.0
6.0 6.0 6.0
0
2
4
6
8
10
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Baseline 1-Year 3-Year 5-Year
Normalized Daytime Sleepiness
Multi-Center Prospective, 126 Patients, Randomized Control Tx, Withdrawal ARM
Apnea Hypopnea Index (AHI) Epworth Sleepiness Scale (ESS)
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17. Existing Inspire Patient
• Ms. GG
• Diagnosed with severe OSA with an AHI of 37.2/h
• Excessively sleepy with her ESS on initial visit was 20 (normal <8)
• Had very broken sleep and was sleeping all day long as per her daughter
• Had tried CPAP but had struggled with finding a mask that fit well
• Inspire implantation on 7/8/2020
• PSG with Inspire on 10/15/20
• AHI with Inspire at 2.6 volts = 9.20/hr
• ESS after her sleep study was 4
• Sleeping through the night and awake the entire day
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18. Existing Inspire Patient
• Ms. PT
• Diagnosed with moderately severe OSA with an AHI of 25.4/h in 2016
• Using CPAP therapy but we could not find a perfect mask that did not leak
• The leak kept disrupting her sleep
• Yet she still felt overall better with using CPAP but not perfect and had to take a sleep aid
• We tried for 2 years to find a mask that would not leak for her
• Inspire implantation on 6/26/2020
• PSG with Inspire on 11/10/2020
• AHI with Inspire at 2.7 volts = 1.30/hr
• Sleeping uninterrupted through the night without using any sleep aids
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19. Our practice data
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20. • Randy Livingston
520-250-0980
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Inspire Patient
PRE Inspire AHI – 28.1 POST Inspire AHI – 4.1

21. How to schedule an appointment
• Call: 480-745-3547
• Submit an appointment request online at sleeplessinarizona.com or email
info@sleeplessinarizona.com
• Scottsdale
• Dr. Ruchir P. Patel
• Dr. Stacey Gunn
• Gilbert
• Dr. Anupama Ramalingam
• Dr. Francisco Ralls
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22. The Insomnia and Sleep Institute of Arizona - Locations
8330 E Hartford
Drive, Suite 100
Scottsdale, AZ
1530 E Williams Field
Road, Suite 204
Gilbert, AZ
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23. Questions
• Please message your questions to us
• Let us know if you’d like to speak to a patient who has Inspire
• www.sleeplessinarizona.com/
Thank you
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