treatment of sleep disordered breathing with posi4onal...
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Treatmentofsleepdisorderedbreathingwithposi4onaltherapy
includinglong-termresults
JolienBeyersBiomedicalscien0stPhDresearcher
SaO2
Body position
Apneas Hypopneas
Sleep stages
Leg Movements PLM
Snoring Periodic snoring
Posi0onalOSA
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Posi0onalOSA
Reference Defini4onCartwright(1984)
SLEEP AHIsupine≥2xAHInon-supine
Marklund(2004)CHEST
AHIsupine≥10/hand
AHInon-supine<10/h
Mador(2005)CHEST
AHIsupine≥2xAHInon-supineand
AHInon-supine<5/hand
15-minthresholdforsleepinbothpostures
§ Pa0entswithPOSAare§ younger(onaverage7yearsyounger)§ lessobese(onaverage7kglessbodyweight)§ lesssevereOSA
RichardWetal.Theroleofsleepposi0oninobstruc0vesleepapneasyndrome.EurArchOtorhinolaryngol2006;263:946-950
OksenbergAetal.Posi0onalvsnonposi0onalobstruc0vesleepapneapa0ents:anthropomorphic,nocturnalpolysomnographic,andmul0plesleeplatencytestdata.Chest
1997;112:629-639
Joostenetal.Phenotypesofpa0entswithmildtomoderateobstruc0vesleepapneaasconfirmedbyclusteranalyses.Respirology2012;17:99-107
Characteris0csPosi0onalOSA
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§ Distribu0onofPOSAoverOSAseverity
MadorMJetal.Prevalenceofposi0onalsleepapneainpa0entsundergoingpolysomnography.Chest2005,128(4):2130–2137
Characteris0csPosi0onalOSA
65.8 %
Posi0onaltherapy
§ Inthepast:‘tennisballtechnique’(TBT)§ SignificantlyreducessnoringandOSAseverity§ Compliancelimitedduetobulkiness
§ Backache§ Discomfort§ Noimprovementinsleepquality
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Posi0onaltherapy
§ Inthepast:‘tennisballtechnique’(TBT)§ SignificantlyreducessnoringandOSAseverity§ Compliancelimitedduetobulkiness
§ Backache§ Discomfort§ Noimprovementinsleepquality
Advances in technology
Posi0onaltherapy
§ Newadvancesinposi0onaltherapy:§ Posi0onalalarmdevices§ Vibra0onalarmdevices
§ Neck-worn§ Chest-worn
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§ ClinicalassessmentofatrialperiodwithSPTinPOSApa0ents
§ Inclusioncriteria:§ AHIsupine≥2xAHInon-supine§ Timeinsupineposi0on≥10%oftotalsleep0me§ TotalAHI≥5events/hoursleep
§ Responder:ΔAHI≥50%
SPTRegistry
Visit4Visit3Visit2Visit1
2 days
+/- 21 days
+/- 7 days: 2 with PSM
SPTRegistry
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Visit4Visit3Visit2Visit1
SPTRegistry
Medibyte(BraebonMedicalCorpora0on.Canada.Kanata)§ 2-nightsleepstudy§ Measurementof
§ BodyPosi0on§ Oximetry§ Pulserate§ Snoringvolume§ Airflow§ Respiratoryeffort
Driver.H.S.etal.(2011).Valida0onoftheMediByte(R)type3portablemonitorcomparedwithpolysomnographyforscreeningofobstruc0vesleepapnea.Canadianrespiratoryjournal18.
137-143.
PortableSleepMonitor
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Visit4Visit3Visit2Visit1
2 days
SPTRegistry
Day0-2=‘Baseline’:SPTmeasuressupinesleep%Day3-9=‘Build-up’:vibra0onswillgraduallyincreaseDay10-28=‘Treatment’:SPTworks100%
SPTRegistry
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Day0-2=‘Baseline’:SPTmeasuressupinesleep%Day3-9=‘Build-up’:vibra0onswillgraduallyincreaseDay10-28=‘Treatment’:SPTworks100%
SPTRegistry
Day0-2=‘Baseline’:SPTmeasuressupinesleep%Day3-9=‘Build-up’:vibra0onswillgraduallyincreaseDay10-28=‘Treatment’:SPTworks100%
SPTRegistry
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Visit4Visit3Visit2Visit1
2 days
+/- 21 days
SPTRegistry
Visit4Visit3Visit2Visit1
2 days
+/- 21 days
+/- 7 days: 2 with PSM
SPTRegistry
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200 patients screened
79 patients did
complete study
22 did not
complete study
POSA confirmed in 101 patiënten
SPTRegistry-Results
45 responders 34 non-responders
54 patients with
positional snoring
POSA not confirmed
in 45 patients
200 patients screened
79 patients did
complete study
22 did not
complete study
POSA confirmed in 101 patiënten
SPTRegistry-Results
45 responders 34 non-responders
54 patients with
positional snoring
POSA not confirmed
in 45 patients
§ Responder:ΔAHI≥50%
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§ Studypopula0onof79pa0ents
§ Characteris0cs:§ Meanage:52±12years§ 81%male§ MedianBodyMassIndex:27(25,28)kg/m²§ MediantotalAHI:11(8,16)events/h§ Median%0meinsupine:27(20,48)
SPTRegistry-Results
SPTRegistry-Results
Baseline 27 (20, 48)%
with SPT 7 (2, 20)%
*
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SPTRegistry-Results
Baseline 27 (20, 48)%
with SPT 7 (2, 20)%
Baseline 31 (23, 52)%
with SPT 5 (1, 17)%
* *
SPTRegistry-Results
Baseline 11 (8, 16)/h
with SPT 5 (3, 10)/h
*
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SPTRegistry-Results
Baseline 11 (8, 16)/h
with SPT 5 (3, 10)/h
Baseline 11 (8, 17)/h
with SPT 3 (2, 5)/h
* *
§ MeanDiseaseAllevia0on(MDA)§ MDA=(ΔAHI(%)xadherence(%ofTST))
SPTRegistry-Results
100
MDA is equal to the surface area of therectangleforwhichthelengthisgivenbythe adjusted adherence (objec0ve SPTuse/total sleep 0me), and the height isgiven by the therapeu0c efficacy (AHIbaseline minus AHI with SPT applied,expressedinpercentage).MDAprovidesameasu re o f o ve ra l l t he rapeu0ceffec0veness.
VandervekenOM,DieltjensM,WoutersK,DeBackerWA,VandeHeyningPH,BraemMJ.Objec0vemeasurementofcomplianceduringoralappliancetherapyforsleep-disorderedbreathing.
Thorax.2013;68:91-6
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§ MDAof45responders
SPTRegistry-Results
§ MDAof45responders
Therapeu
0cefficacy(%
)
Adjustedadherence(%)
74%
96%
MDA = 72 %
Reduc0oninsupineposi0on
SPTRegistry-Results
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§ MDAof45responders
Therapeu
0cefficacy(%
)
Adjustedadherence(%)
74%
96%
MDA = 72 %
Reduc0oninsupineposi0on
SPTRegistry-Results
Therapeu
0cefficacy(%
)
Adjustedadherence(%)
71%
96%
MDA = 68 %
Reduc0oninAHI
79 POSA patients included
22 responders
35 patients did not purchase the SPT
22 non-responders
44 patients did purchase the SPT
SPTRegistry-Results
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N=35 MainreasonfornotpurchasingSPT Number %1 Objec0veresultsinsufficient 6 172 Couldnottoleratevibra0ons 5 143 Noreasongiven 5 144 Tooexpensive 4 115 Subjec0ve:persistentday0mesleepiness,dissa0sfied 3 9
SPTRegistry-Results
SPTonthelongterm–Firstresults§ 1yearfollow-upincludes:
§ FullPSG§ Detailedassessmentofsubjec0vesymptoms
§ 33pa0entsun0llnow
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SPTonthelongterm–Firstresults
§ 33pa0entsPSGaqer1yeartreatment:
§ 17responders(52%)§ 15treatmentsuccess(45%)
N=33 Baseline 1yearfollow-up P-value
BMI(kg/m²) 27,4(25,6;28,6) 27,4(25,0;28,7) 0,934
TotalAHI(events/hour) 16,4(12,2;23,3) 6,4(3,2;16,9) 0,000*
AHIsupine(events/hour) 41,3(23,0;58,0) 5,2(0;27,0) 0,000*
AHInonsupine(events/hour) 5,0(2,3;8,8) 5,0(2,9;9,8) 0,197
%supinesleep 37,5(21,0;59,7) 2,3(0;11,8) 0,000*
ESS 9,0(3,5;12,5) 8,0(5,0;12,0) 0,818
VAS 5,0(2,0;7,0) 2,0(0,75;6,0) 0,051
SPTonthelongterm–Firstresults
0
20
40
60
80
100
120
%supinebaseline %supinewithSPT
Timespen
tinsupine
posi0on
(%)
Reduc0oninpercentageofsupineposi0oninthetoalgroup(N=33)
Baseline 38 (21, 60)%
with SPT 2 (0, 12)%
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SPTonthelongterm–Firstresults
0
20
40
60
80
100
120
%supinebaseline %supinewithSPT
Timespen
tinsupine
posi0on
(%)
Reduc0oninpercentageofsupineposi0oninthetoalgroup(N=33)
0
20
40
60
80
100
120
%supinebaseline %supinewithSPT
Timespen
tinsupine
posi0on
(%)
Reduc0oninpercentageofsupineposi0onintheresponderondergroup(N=17)
Baseline 38 (21, 60)%
with SPT 2 (0, 12)%
Baseline 57 (40, 68)%
with SPT 5 (0, 7)%
SPTonthelongterm–Firstresults
0
10
20
30
40
50
60
AHIbaseline AHIwithSPT
AHI(even
ts/h)
Reduc0oninAHIinthetotalgroup(N=33)
Baseline 16 (12, 23)/h
with SPT 6 (3, 17)/h
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SPTonthelongterm–Firstresults
0
10
20
30
40
50
60
AHIbaseline AHIwithSPT
AHI(even
ts/h)
Reduc0oninAHIinthetotalgroup(N=33)
0
10
20
30
40
50
60
AHIbaseline AHIwithSPT
AHI(even
ts/h)
Reduc0oninAHIintherespondergroup(N=17)
Baseline 16 (12, 23)/h
with SPT 6 (3, 17)/h
Baseline 20 (14, 26)/h
with SPT 4 (3, 6)/h
SPTonthelongterm–Firstresults
§ 33pa0entsPSGaqer1yeartreatment:§ SPTdatacollectedin20pa0ents
§ Adherence:67,2±28,0%§ Adherenceinrespondergroup(n=17):80,5±24,7%
N=20 Firstweek(diagnosis) Lastweek P-value
%supinesleep 23,6(10,8;37,4) 8,3(2,2;16,0) 0,001*
Numberofvibra0ons 19,6(5,8;45,3) 19,7(2,9;39,3) 0,520
Responspercentageonvibra0ons 20,8(15,7;38,9) 18,1(15,7;38,9) 0,737
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SPTonthelongterm–Firstresults
Baseline 24 (11, 37)%
with SPT 8 (2, 16)/%
0
20
40
60
80
100
%supinefirstweek %supinelastweek
Timespen
tinsupine
posi0on
(%)
Reduc0oninpercentageofsupineposi0oninthetoalgroup(N=33)
SPTonthelongterm–Firstresults
Baseline 24 (11, 37)%
with SPT 8 (2, 16)/%
Baseline 27 (14, 38)%
with SPT 6 (1, 15)%
0
20
40
60
80
100
%supinefirstweek %supinelastweek
Timespen
tinsupine
posi0on
(%)
Reduc0oninpercentageofsupineposi0oninthetoalgroup(N=33)
0
10
20
30
40
50
60
%supinefirstweek %supinelastweek
Timespen
tinsupine
posi0on
(%)
Reduc0oninpercentageofsupineposi0onintheresponderondergroup(N=17)
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SPTonthelongterm–Firstresults
§ MDAof17responders
SPTonthelongterm–Firstresults
§ MDAof17responders
Adjustedadherence(%)
Therapeu
0cefficacy(%
)
Reduc0oninAHI
81%
78%
MDA = 63 %
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SPTonthelongterm–Firstresults
§ MDAof17responders
Adjustedadherence(%) Adjustedadherence(%)
Therapeu
0cefficacy(%
)
Therapeu
0cefficacy(%
)
Reduc0oninsupineposi0onReduc0oninAHI
81%
64%
81%
78%
MDA = 63 % MDA = 52 %
Conclusion§ SPTregistry:
§ Highoveralleffec0veness(MDA)inrespondergroup§ Atrialperiodcanbeusedas“selec0ontool”
§ Predic0onoftherapysuccess§ Subjec0vecomplianceandacceptance
§ 1yearfollow-up:§ Overalleffec0venessremainshighatlongtermfollow-up§ Hightherapysuccessrate(45%)§ PermanentuseoftheSPTisnecessary
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Thankyouforyourauen0on