Con$nuousNega$veExternalPressure(cNEP)fortheTreatmentof
Obstruc$veSleepApnea(OSA):APilotStudy
JKram1;RWoidtke1;KKlein2;RRose3
1CaliforniaCenterforSleepDisorders,Alameda,CA;2Endpoint,LLC,BainbridgeIsland,WA;3Sommetrics,Inc.,SanDiego,CA
INTRODUCTION
•  Obstruc;vesleepapnea(OSA)isacommonand
seriouscondi;onwhichresultsinsignificant
cardiovascular,endocrineandneurocogni;ve
comorbidity.Itises;matedthat10-17%ofmales
and3-10%offemaleshaveOSA.(Peppard,2013)
•  Con;nuousposi;veairwaypressure(CPAP)remains
thefirstlinetherapy.Othertherapiesincludeoral
appliances(OA),surgery,andgenioglossalimplants.
•  WithCPAPandOA,ini;alacceptanceand
adherencetotherapyispoor.Othertherapeu;c
op;onsareneededtomaximizecompliance,and
thusleadtobeAeroutcomes.
•  Westudiedanoveltreatmentapproachthatavoids
someimportantlimita;onsofCPAP.Con;nuous
nega;veexternalpressure(cNEP)isappliedtothe
anteriorupperairwaybymeansofaso\silicone
collarwhich,whenappliedtotheneck,pullsthe
structuresoftheanteriorairwayforward,helpingto
preventairwaycollapse.(Kato,2015)
•  cNEPhasbeenshowntobeeffec;veinreducing
respiratoryimpairmentduringconsciousseda;on.
(Kais,2016)
•  ThispilotstudyevaluatedsubjectswithOSAto
determinetheefficacy,safety,andpossible
predictorsofresponsetocNEP.
METHODSANDMATERIALS
StudyDesign
•  Openlabel
•  Twocollarsizeswereusedtoestablishtheonethat
fitbestatapressureof-25cmwaterinthesupine
posi;on
•  Subjectswhometalleligibilitycriteriawere
scheduledforovernightin-labaAended
polysomnography(PSG)for;tra;onofcNEP
pressure
•  Nega;vepressurerangetestedwasbetween-20
and-45cmwater
•  ThestudywasapprovedbyWesternIRB
Forinves$ga$onaluseonly.PresentedatSLEEP2016.
KeyInclusionCriteria
•  Maleorfemalesubjects
•  DocumentedOSA
•  PSGorHomeSleepTes;ng(HST)withintheprior6
monthsindicatedAHI>15and<20%centralapneas
•  Age22-70yearsold
•  Subjectssigninformedconsent
KeyExclusionCriteria
•  Severecardiopulmonaryorneurologicdisease
•  ExcessivefacialhairintheregionwherethecNEPcollaris
posi;oned
•  Caro;dvasculardisease
•  Previousmajornecksurgeryorradia;ontherapytothe
cervicalregion
•  Anatomicalabnormali;esintheneckorpharyngeal
region
StandardAASMprotocols(2012)fortheconductofPSGand
scoringofsleepandrelatedrespiratorydatawereused.
Hypopneawasscoredusingthe4%criteria.Thesubject’s
responsewascategorizedaccordingtocriteriasimilarto
thoseoftheAASMforresponsetoCPAP;tra;on.
An“excellent”responserequiredtheachievementofanAHI
of<5,anda“par;al”responserequiredareduc;oninAHIof
>50%,withanAHIof<15/hr.
RESULTS
DISCUSSION
Fi\eensubjectswerestudied.Themeanagewas56(range
39–65),53%weremales,andmeanbaselineAHIwas43.9
(15.5–79.6).Thirteensubjects(87%)wereresponders;nine
(60%)showedanexcellentresponseandfour(27%)apar;al
response.
Newtreatmentop;ons,whichareefficaciousandsimple
touseforpa;entswithOSA,aregreatlyneeded.This
studyhasdemonstratedthatcNEPhasthepoten;alto
improveOSAinpa;entswithmoderatetosevereOSA.
ThewiderangeofbaselineAHI,BMIandneck
circumferencesuggeststhatapar;alorexcellent
responsecanbeexpectedinmostpa;entswithOSA.This
technologyshowspromiseforaddingtoavailableop;ons
fortreatmentofOSAwithafavorablesafetyprofile.In
general,subjectsfoundthecollartobecomfortableand
wouldbewillingtotryusingthetechnology.No
predictorsofresponseweredemonstratedinthissample.
Table1.DemographicsandClinicalCharacteris$cs
n=15
MEAN
RANGE
Age
56
39-65
BMI
34.8
25-48.6
BaselineAHI
43.9
15.5-79.6
NeckCircumference(cm)
40.5
33-48
Gender
(8M,7F)
CONCLUSIONS
Table2.KeyFindings(means)
Excellent
responders
n=9/60%
Par$al
responders
n=4/27%
Nonresponders
n=2/13%
AGE %MALE BMI
MALLAMPA
TI
NECK
BL
BLAHI*
CIRC
CPAP**
56
22%
35
3.8
37.6
37
9
56
100%
32
2.8
44.3
58
10
52
100%
40
4
46
44
16
*BaselineAHI;**BaselineCPAPPressure
Inthissmallsample,therewerenoclearpredictorsofa
response.
ADVERSEEVENTS
Adverseeventswerelimitedtomildcutaneouserythema,
atthesiteofcontactofthecNEPcollarwiththeneck(3/15
subjects).Onesubjectdevelopedmildblistering.Inall
cases,adverseeventsresolvedspontaneouslywithout
clinicalinterven;on.
Fig1:ThecNEPcollarfiAedalongthemandibleover
theupperairway.
LIMITATIONS
•  Smallsamplesize
•  Singlenightin-laboratoryPSG
Ahighpropor;onofpa;entswithdocumentedOSA
showedaresponsetocNEP,includingthosewithhigh
baselineAHIs.cNEPwaswell-tolerated.Nopredictors
ofresponsewereiden;fied.Furtherstudiesare
indicated.
REFERENCES
Kais,S.S.,Klein,K.B.,Rose,R.M.,Endemann,S.,&Coyle,
W.J.(2016).Con;nuousnega;veexternalpressure
(cNEP)reducesrespiratoryimpairmentduring
screeningcolonoscopy.Endoscopy,48,584-587.
Kato,S.,Isono,S.,Amemiya,M.,Sato,S.,Ikeda,A.,
Okazaki,J.,Sato,S.,…Ishikawa,T.(2015).Submental
nega;vepressureapplica;ondecreasescollapsibility
ofthepassivepharyngealairwayinnonobese
women. JournalofAppliedPhysiology,118,
912-920.
Peppard,P.E.,Young,T.,Barnet,J.H.,Palta,M.,Hagan,
E.W.,&Hla,K.(2013).Increasedprevalenceofsleepdisorderedbreathinginadults.AmericanJournalof
Epidemiology,177(9),1006-14.
ThisstudywassupportedbySommetrics,Inc.SanDiego,CA