UoM 2016 BMEn5920 - Inspire Better Sleep - release
Transcript of UoM 2016 BMEn5920 - Inspire Better Sleep - release
Inspire Better Sleep
Quan Ni, PhD
Inspire Medical Systems
www.inspiresleep.com
Sleep Apnea by Numbers
• Obstructive Sleep Apnea (OSA) affects 18 million Americans
• OSA increases risks for
–Hypertension by 2.9 times
– Stroke by 3.8 times, and
–Car crashes by 2.4 times
Sleep Study
Intermittenthypoxia
Resp effort continues
No air flow
arousals
Polysomnography
1 minute
Apnea hyponea index (AHI): number of apnea and hypopnea events per hour, AHI~100
OSA and Survival
Young etal 2008, Wisconsin Sleep Cohort, n=1,522, 18 year follow-up
Continuous Positive Airway Pressure
CPAP… and Adherence
• CPAP is an effective first-line therapy for OSA patients who use it consistently
• General CPAP adherence is about 50%
• Many factors limit adherence
7
Tongue Protrusion as a Therapy
Upper Airway Neuroanatomy
9
Styloglossus (SG)
Hypoglossal Nerve (CN XII)
Hyoglossus (HG)
Genioglossus (GG)
Inspire II Systems
10
Stimulation Lead
Respiratory Sensing Lead
Implantable Pulse Generator
Patient Remote
Physician Programmer
Development Process
Plan
• Needs
• Features
• Requirements
Development
• Design
• Prototype
• Manufacture
Testing
• Bench test
• Pre-clinical testing
• Human testing
Clinical Testing
8 patients @ 4 centers
2001
First in man
1 publication
Inspire 2&3
Feasibility Trials
22 patients @ 4 centers
2009/10
Patient selection
Implant technique
1 peer reviewed publication
126 patients @ 22 centers
2012 /13
Safety / Efficacy /
FDA Review
N Eng J Med &
other publications
Inspire STAR
Pivotal Trial
12 patients @ 7 centers
2010/11
Preliminary
Safety / Efficacy
2 peer reviewed publications
Inspire 2/3
Feasibility Study
Inspire 1
Proof of Principle
Inspire 2/3
Feasibility Study
FDA Approval April 2014
Upper Airway Stimulation Effect
Stimulation ActiveNo Stimulation
EEG
EMG
Nasal
Therm
Chest
Abdm
SaO2
13
Significant Reduction In OSA Severity
Strollo et al on behalf of STAR trial investigators N Engl J Med 2014
Strollo et al on behalf of STAR trial investigators N Engl J Med 2014
Improve Daytime Functioning
Epworth Sleepiness Scale (synthesized): chance of dozing (0-3) during 8 situations:
Sitting and reading; Watch TV; Meeting; Passenger in a car;
Lying down in PM; Sitting and talking; Sitting after lunch; Sitting in traffic
Partner-Reported Level of Snoring
17
6.5%
49.0%
11.1%
36.0%
28.7%
7.0%
24.1%
3.0%
29.6%
5.0%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
Baseline 12-Months
Pe
rce
nt
of
Par
tne
rs
Bed partner leaves room
Very intense snoring annoying toanyone nearby
Loud snoring, enough to bebothersome to the bed partner
Soft snoring which doesn’t interrupt the bed partner’s sleep (social snoring)
No snoring at all
n=108 n=100
18%
85%
STAR trial data