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TNI ® Studies 44 Therapy A Nasal Cannula Can Be Used to Treat Obstructive Sleep Apnea Brian M. McGinley 1 , Susheel P. Patil 1 , Jason P. Kirkness 1 , Philip L. Smith 1 , Alan R. Schwartz 1 , and Hartmut Schneider 1 Diagnostics 1 JohnsHopkinsSleepDisordersCenter,DivisionofPulmonaryandCriticalCareMedicine,JohnsHopkinsUniversity,Baltimore,Maryland Rationale: Obstructive sleep apnea syndrome is due to upper airway obstruction and is associated with increased morbidity. Although continuous positive airway pressure efficaciously treats obstructive apneas and hypopneas, treatment is impeded by low adherence rates. Objectives: To assess the efficacy on obstructive sleep apnea of a minimally intrusive method for delivering warm and humidified air through an open nasal cannula. Methods: Eleven subjects (age, 49.7 � 5.0 yr; body mass index, 30.5 � 4.3 kg/m 2 ), with obstructive apnea–hypopnea syndrome ranging from mild to severe (5 to 60 events/h), were administered warm and humidified air at 20 L/minute through an open nasal cannula. MeasurementsandMainResults: Measurements were based on standard sleep-disordered breathing and arousal indices. In a subset of patients pharyngeal pressure and ventilation were assessed to determine the mechanism of action of treatment with nasal insufflation. Treatment with nasal insufflation reduced the mean apnea– hypopnea index from 28 � 5 to 10 � 3 events per hour (p � 0.01), and reduced the respiratory arousal index from 18 � 2 to 8 � 2 events per hour (p � 0.01). Treatment with nasal insufflation reduced the apnea–hypopnea index to fewer than 10 events per hour in 8 of 11 subjects, and to fewer than 5 events per hour in 4 subjects. The mechanism of action appears to be through an increase in end-expiratory pharyngeal pressure, which alleviated upper airway obstruction and improved ventilation. Conclusions: Our findings demonstrate clinical proof of concept that a nasal cannula for insufflating high airflows can be used to treat a diverse group of patients with obstructive sleep apnea. Keywords:treatmentwithnasalinsufflation,TNI;pharyngealpressure Obstructive sleep apneasyndrome is duetoupper airwayobstruction leading to intermittent hypoxemia, sleep fragmentation,metabolicdysfunction(1,2),andincreasedcardiovascular morbidity and mortality (3, 4). Current treatment options, includingcontinuouspositiveairwaypressure(5),oralappliances (6),andsurgicalprocedures(7),areoftenintrusiveorinvasive, and not well tolerated, leaving a vast number of subjects untreated (8, 9). Therefore, improved therapeutic strategies are requiredtotreatsleepapneasandhypopneasandtheirassociatedmorbidityandmortality.Upperairwayobstructionisduetoincreasedpharyngealcollapsibility(10–12),whichdecreasesinspiratoryairflowasmanifested by snoring andobstructive hypopneasand apneas (13). This defect in upper airway collapsibility can be overcomeby elevatingnasalpressure.Infact,somewhatgreaterlevelsofnasal (ReceivedinoriginalformSeptember18,2006;acceptedinfinalformMarch14,2007) SupportedbyHL-72126,HL-50381,HL-37379,HL-077137,NHMRC-353705, andSeleonGmbH,Germany. Correspondence and requests for reprints should be addressed to Hartmut Schneider,M.D.,Ph.D.,JohnsHopkinsAsthmaandAllergyCenter,5501Hopkins BayviewCircle,Room4B47,Baltimore,MD21224.E-mail:hschneid@jhmi.edu Am J Respir Crit Care Med Vol 176. pp 194–200, 2007 Originally Published in Press as DOI: 10.1164/rccm.200609-1336OC on March 15, 2007 Internet address: www.atsjournals.org AT A GLANCE COMMENTARY Scientific Knowledge on the Subject Highlevelsofcontinuouspositiveairwaypressure(CPAP) areneededtoalleviateobstructiveapneas;lowcompliance withCPAPimpedesitstherapeuticeffectiveness;and,becausehypopneascanbetreatedwithlowlevelsofCPAP,nasalinsufflationofairmighteffectivelytreatmildobstructivesleepapnea. What This Study Adds to the Field Nasalinsufflation canprovide distinctclinicaladvantages overCPAPforasubstantialproportionofthepatientpopulationwithsleepapnea. pressure are required to abolish apneas than hypopneas, and to restore normal levels of inspiratory airflow (12, 14). Thus, minimallyintrusivemethodsfordeliveringlowlevelsofairway pressuremayberemarkablyeffectiveintreatinghypopneas. At present, continuous positive airway pressure (CPAP) is most effective in eliminating apneas and hypopneas, although long-termeffectivenessiscompromisedbylowadherencethat is estimated at only 50 to 60% (15, 16). Poor adherence has beenattributedtothesideeffectsassociatedwithnasalCPAP, includingdifficultytoleratingpressureandthenasalmaskinterface,nasal irritation, claustrophobia, andskin breakdown (17, 18).Toaddresstheseissues,wedevelopedasimplifiedmethod forincreasingpharyngealpressurebydeliveringwarmandhumidifiedairatacontinuoushighflowratethroughanopennasal cannula.Thepresentstudywasdesignedtodeterminewhether treatment with nasal insufflation (TNI) alleviates obstructive sleepapneaandhypopneaacrossaspectrumofdiseaseseverity. Some of the results of these studies have been previously reportedintheformofabstracts(19,20). METHODS Participants SubjectswererecruitedfromtheJohnsHopkinsSleepDisordersCenter (Johns Hopkins University, Baltimore, MD) if they had more than fiveobstructivedisorderedbreathingepisodesperhourofsleepona standardovernightpolysomnogram.Patientswereselectedtoprovide abalancedrangeofdiseaseseverityencompassingaspectrumofmild (apnea–hypopnea index [AHI] � 5–15 events/h, n � 3), moderate (AHI,15–30events/h,n�5),andsevere(AHI �30events/h,n�3) sleep apnea (Table 1), withacomparable mixof sex and body mass index.SevenpatientswerereceivingCPAP,fourofwhom(subjects3, 6, 9, and 10) participated in the study because they had difficulties toleratingCPAP,withcompliancedefinedasCPAPusefor4hoursor
TNI ® Studies Therapy Diagnostics McGinley,Patil,Kirkness,etal.:ObstructiveSleepApneaTreatment 195 TABLE 1. ANTHROPOMETRICS AND SLEEP-DISORDERED BREATHING INDICES DiseaseSeverity Mild Moderate Severe Subject1 Subject2 Subject3 Subject4 Subject5 Subject6 Subject7 Subject8 Subject9 Subject10 Subject11 Mean SEM Anthropometricdata Sex M M M F F M F M F M F Age,yr 33 24 49 39 31 56 42 53 70 77 56 49.7 5.0 Height,cm 168 190.5 180.0 152.4 160 182.9 154.9 172.7 157.5 182.9 172.7 170.7 4.1 Weight,kg 70.9 120.9 74 63.9 70.9 91.7 169.1 72.0 60.0 86.8 66.67 81.9 12.7 BMI,kg/m 2 25.2 33.2 22.6 27.4 27.6 27.4 70.3 24 24.1 25.9 22.35 30.5 4.3 Sleep-disorderedbreathing AHI,events/h 5 8 13 19 20 21 22 30 39 46 58 27.7 4.7 HI,events/h 4 7 12 19 20 20 19 26 4 29 23 17.9 2.4 AI,events/h 1 1 1 0 0 1 3 4 35 17 35 9.8 4.3 AveragebaseSa O2 ,% 96.7 95.2 94.2 97.5 96.5 96 97.3 94.7 97.2 93.8 95.4 95.8 0.4 AveragelowSa O2 ,% 94.5 93.4 92.3 93.3 92.4 91.3 91.9 90.9 87.1 87.3 90.4 91.0 0.7 Definitionofabbreviations:AHI �apnea–hypopneaindex;AI �apneaindex;BMI �bodymassindex;HI �hypopneaindex;Sa O2 �oxygensaturation. morepernight,for70%ormoreofnights.Patientswereexcludedif theyhadcentralsleepapneaorseriousmedicalconditions.Informed consentwasobtainedfromallsubjects,andtheJohnsHopkinsUniversityInstitutionalReviewBoardapprovedtheprotocol. Study Procedures Polysomnography.PolysomnographywasperformedwithSomnologica biosignal recording and analysis software (Embla, Broomfield, CO). Signalsincludedelectroencephalograms(C3-A2,A2-O1),leftandright electrooculograms,submentalelectromyogram,tibialelectromyogram, electrocardiogram,oxyhemoglobinsaturation,bodypositionviainfraredvideo camera,nasal cannula formeasuring airflow (Nights 2and 3),andthoracicandabdominalbeltsformeasuringrespiratoryeffort. OnNight1,apneumotachometer(21)attachedtoanasalCPAPmask (Respironics,Murraysville,PA)andafluid-filledcatheter(CooperSurgical,Trumbull,CT)wereusedtomeasureventilationandsupraglottic pressureonandoffTNI. Nasalinsufflation. Anaircompressor(Seleon,Freiburg,Germany) deliveredatthenoseaconstantflowrateofupto20L/minute,which wastheupperlimitofthecurrenttechnology,giventhedimensionsof the cannula. A heater and humidifier regulated the temperatureand humidity.Aheatedwirewasincorporatedintothelumenofthenasal cannula tubing to achieve a temperature of 30 to 33�C and relative humidity of approximately 80% at the nasal outlet (Figure 1). (For nasalcannuladimensions,seethecaptiontoFigure1). Study Protocols OnNight1(titrationnight),subjectsinitiatedsleepon5L/minuteon TNI for reasons of comfort. When subjects had established a stable period (� 10 min) of non–rapid eye movement (NREM) sleep, TNI wasappliedat0,10,or20L/minutefor5-minuteintervalsinrandom order. These trials were repeated a minimum of three times at each TNIlevelinthesupinepositionduringNREMsleep. SubjectswerethenrandomizedtoseparatenightsonandoffTNI at20L/minute.Standardpolysomnographicrecordingtechniqueswere employedtocharacterizesleepandbreathingpatternsonthesenights. OnthebasisofthefindingsintheTNItitrationstudy,weanticipated that patients who had predominantly hypopneas would experience a greatereffectthanthosewhoalsohadobstructiveapneas. Analysis Polysomnography.Standardpolysomnographicscoringtechniqueswere used to stage sleep (22), arousals(23), and respiratoryevents, which werescoredaccordingtothe“Chicagocriteria”(24). Respiratoryindices. Inbrief,anapneawasdefinedascompletecessationofairflowformorethan10seconds.Hypopneawasdefinedas a greater than 30% reduction of airflow. Flow-limited events were scored ashypopneas ifairflow was reducedless than30% compared withadjacentbreathsandwasassociatedwitheitheranarousalfrom sleeporoxyhemoglobindesaturationequaltoorgreaterthan3%.Each respiratory event (apnea and hypopnea) was subclassified as either centralorobstructiveonthebasisofassessmentoftherespiratoryflow and effort signals (supraglottic pressure catheter or abdominal and thoracicplethysmography)(24).Bodypositionwascarefullymonitored during both the baseline and treatmentnights, and anAHI for each individualwascalculatedforthesupineandsidepositionsseparately. AnoverallAHIwasthenproducedbyweightingthetimespentineach body position on the first night. On the second night, we applied a positionalweightingfactorfromthefirstnighttocalculateanoverall AHI. Arousal analysis. Arousals were scored as an abrupt shift in frequencythatincluded �, �,and �frequenciesgreaterthanorexceeding 16Hz,butnotspindlesafteraminimumof10consecutivesecondsof stablesleep,andarousalsinREMwerescoredonlyifaccompaniedby anincreaseinsubmentalelectromyogramamplitude(23).Assessment Figure1. Nasalcannulafordeliveryofwarmhumidifiedairtoapatient (treatmentwithnasalinsufflation).Ascanbeseen,thecannulaisdesignedtoleavethenoseopen,andthusapatientcanexpirefreely throughthenose.Dimensionsofthecannulaareasfollows:length, 1,800mm;outerdiameter,5mm.DimensionsofthetubeaftertheY piece:length,440mmeach;innerdiameter,3.4mm;dimensionof theprongs,5mm(outerdiameter,eachnostril).Thecannulahasbeen designedtodecreaseanypotentialnoisecausedbythehighflowof air,minimizingnoise-inducedsleepdisruption. 45
Page 1 and 2: PRODUCT CATALOGUE We like to suppor
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Page 9 and 10: Products ADVANTAGES: Therapy Diagno
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