sleep apnea: is it time to retire? 2020/day...sleep apnea: is it time to retire? i n t e g r i t y...

Sleep Apnea: Is it time to retire?

No doc, I’m perfectly healthy, I have no medical issues! I

can still fly!

I know I was healthy last week, but now I’m retiring…I need

my Sleep Apnea diagnosis!

I n t e g r i t y - S e r v i c e - E x c e l l e n c e 1

Major Stephen Vela, USAF, BSC, PA-C, CPAAPA

Sleep Apnea: Is it time to retire?


What will you learn from this?n Identify signs, symptoms, and high-risk populations for OSA

n Discuss available clinical screening and outcome assessment tools

n Understand fitness for duty and deployment restrictions for AD personnel

n Understand various treatment methods of OSA

n Review the “Travis Kit” findings for use in deployed “Austere” environments with “non-reliable” power sourcesn Travis Kit success stories?

n Future areas of research regarding CPAP machines/batteries

Fatigue and Loud Snoring?


Common signs and symptoms we expect1,4

n Loud Snoring

n Waking feeling unrested

n Observed apneic events during sleep

n Loud snoring

n Male neck circumference >=17 inches, female >=16 inches

n Daytime somnolence/fatigue

n BMI >35 kg/m2

n Age >50 years old

I’m a Pilot…I Can Fly.


High-Risk Populations2

n Pilots (long distance such as commercial and military heavies)

n Truck drivers (long-haul)

n Diagnosesn Congestive Heart Failuren Coronary artery diseasen Obesityn Pulmonary hypertensionn DM2n History of stroke

Screening & Outcome Assessment Tools


American Academy of Sleep Medicine criteria2

n Accuracy

n Cutoff values for scoring

n Likelihood ratio

n Negative predictive value

n Positive predictive value

n Sensitivity

n Specificity

n Platforms (electronic, face-to-face, paper)

n Grade readability



American Academy of Sleep Medicine (AASM) criteria3

n Outcomesn Adherencen Blood pressuren Cardiovascular/cerebrovascular eventsn Daytime somnolence/fatiguen Motor vehicle/occupational hazardn Quality of life

n Functionaln Costn Source of information (clinician, patient, observer)



AASM’s CPG Recommendations3

n Do not use clinical tools, questionnaires, or algorithms to diagnose in the absence of polysomnography (PSG) or home OSAtesting*

n If home testing is negative or inadequate, confirm with PSG

n If patient has significant co-morbidities, PSG is preferred

n If clinically appropriate, complete a split-night protocol rather than full-night*

n If initial PSG is negative, but clinical suspicion is high, repeat PSG to confirm

Screening Assessment Tools


AASM’s 2018 Task Force (TF)2

n 10 screening tools were reviewed with four individual tools meeting a majority of predetermined validation metricsn STOP-BANG: found to have most diverse portfolio of validation

datan Symptomless Multivariable Apnea Prediction (sMVAP): validation

study conducted in an exclusively perioperative patient populationn Epworth Sleepiness Scale (ESS): Although commonly used as an

OSA screening tool, the TF found there was a lack of validation for targeted PSA patient populations

n STOP-BAG (no neck circumference): TF found superior performance validation in predicting OSA in stroke population

n Berlin Questionnaire, OSA 50, & Wisconsin Sleep Questionnaire



Ref 4



AASM’s 2018 Task Force (TF)2

n In 2018, none of the reviewed screening tools was freely available

n Now, a quick search on an internet search engine will make almost all freely availablen The ESS is included in AHLTA

n The best screening tools require a combination of objective measures reported by clinicians and subjective reported by patients

n Completion time ranges between 1-5 minutes and are often used in combination with the ESS

n The increase in reliability offered by objectively-measured physical findings-vs-slightly increased burden to collect these clinical variables

Outcome Assessment Tools


AASM’s 2018 Task Force (TF) 2

n 20 Outcome assessment tools were reviewed by the TFn While none of the tools were sufficiently validated to warrant a

recommendation the Functional Outcomes of Sleep Questionnaire (FOSQ) met most validation metrics for OSAn FOSQ: included the most relevant outcome measures*

n Some only report on general outcomes, such as the 36-Item Short Form Health Survey (SF-36) for quality of life, lacking ore immediate outcomes such as adherence

n Calgary Sleep Apnea Quality of Life Index (SAQLI), Sleep Apnea scale of the Sleep Disorders Questionnaire (SA-SDQ), and Symptoms of Nocturnal Obstruction and Related Events (SNORE) tools are among those specifically developed for assessment of OSA patients

Outcome Assessment Tools


Ref 5

Military Concerns?


Medical Standards Directory & AFI 48-123 (10 Sep 19)6

n Changes from previous MSD updatesn G5- Airmen with any degree of severity of obstructive sleep

apnea (OSA) who continue to have symptoms despite their treatment with Positive Airway Pressure (PAP) machine, oral positional devices, or who require supplemental oxygen, or any chronic medication to maintain wakefulness

n G6- Current or history of sleep apnea (including OSA, mixed/central sleep apnea, regardless of Apnea Hypopnea Index (AHI) or Respiratory Disturbance Index (RDI) values) or other clinical sleep disorders, regardless of prior treatment.

Military Concerns?


Deployment Waiversn CENTCOM MOD 147 Tab A, #13 page 4 &5

n Requires diagnosis with PSG, NOT home sleep study!n Repeat PSG not required for previously diagnosed Airmen

unless clinically indicated (i.e. significant change in body habitus, corrective surgery or return of OSA symptoms)

n Must not pose a safety risk if positive air pressure (PAP) therapy be unavailable

n Moderate and severe OSA require a compliance report demonstrating ≥ 4 hrs use per night for >70% of nights in a 30 day period

n Documentation if controlled with oral device vs PAPn Complex OSA, central apnea, or require advanced modes of

ventilation are generally non-deployable

Military Concerns?


Deployment Waiversn CENTCOM MOD 147 Tab A, #13 page 4 & 5(continued)

n Airmen deploying with PAP therapy deploy with machine that has a rechargeable battery backup* and supplies (filters, masks, etc.)

n Asymptomatic mild OSA (AHI or RDI < 15) controlled with or without PAP therapy is deployable without need for waiver

n Moderate to severe OSA as well as symptomatic OSA require waiver as follows:n Individuals with confirmed compliance and access to power

sources, as well as an absence of complex apnea, central apnea, need for advanced ventilation modes, or additional disqualifying conditions do not require a waiver. If any of these factors are not adequately addressed, waiver is required.

Military Concerns?


Deployment Waiversn Africa Command Instruction ACI 4200.09A8 pages B-7 & 8 (13 Sep 19)

n Requires diagnosis with PSG, NOT home sleep study!n Repeat PSG not required for previously diagnosed Airmen unless

clinically indicated (i.e. significant change in body habitus, corrective surgery or return of OSA symptoms)

n USAFRICOM waiver authority may request repeat polysomnography to further evaluate a specific waiver request

n Asymptomatic mild OSA (with or without CPAP) does not require a waiver. (AHI or RDI < 15)

n Asymptomatic, treated moderate (AHI 15-30/hr) or severe (AHI>30/hr) OSA requires a medical waiver for travel of > 30 days

n Personnel with OSA of any severity who have symptoms despite treatment are not eligible for a medical waiver

Military Concerns?


Deployment Waiversn Africa Command Instruction ACI 4200.09A8 pages B-7 & 8 (continued)

n Healthcare provider submitting waivers must document CPAP compliance/adherence to case summary section of USAFRICOM Medical Waiver Request Form or provide documentation (compliance report) demonstrating ≥ 4 hrs use per night ≥ 5 nights per week in a 30 day period

n Must know if machine is equipped with wireless or cellular communication and be able to disable this feature*

n Airmen deploying with CPAP therapy deploy with machine that has a rechargeable battery backup* and supplies (filters, masks, etc.)

n Individuals with AHI >60/hr or co-morbid severe cardiovascular or neurologic conditions should consult a sleep specialist, pulmonologist, or neurologist (in this preferred order) before waiver submission

Treatment Options9


Quick recap…n Continuous Positive Airway Pressure9,10 (CPAP)

n Automatic Positive Airway Pressure9 (APAP)n Bi-level Positive Airway Pressure9 (BiPAP)

n Oral appliances9,11 (OA)n Normally can be constructed by Dentaln maxillary and mandibular splint which holds the lower jaw forward

during sleep

n Upper Airway Stimulation9,12 (UAS)n UAS augments neural drive by unilaterally stimulating the

hypoglossal nerven Phasic stimulation of the hypoglossal nerve via a cuff electrode

connected to an implanted impulse generator which incorporates an effort sensor placed between the intercostal muscles

n Stimulation sequence can be programmed to protrude forward

Treatment Options9


Quick recap…n UAS9,12 (continued)

n Neurostimulation is accomplished with a stimulator placed in the right infraclavicular area

n This stimulator is connected unilaterally to the right hypoglossal nerve to activate the genioglossus muscle

n To phase this stimulation to respiration (inspiration), a sensor is placed in the fourth intercostal space between the internal and external intercostal muscles

n The UAS system is activated via a patient programmer utilized only during the sleep period

n While the primary mechanism of UAS is forward movement of thetongue, mechanical coupling with the soft palate results in airwayenlargement in both the retrolingual and retropalatal airways

Treatment Options9


Quick recap…continued…n Oropharyngeal exercises9

n These consist of a set of isometric and isotonic exercises involving the tongue, soft palate, and lateral pharyngeal wall

n A steady demonstrated that 3 months of exercise trainingreduced OSA severity by 39% in a randomized trial (n=16)

n Must be performed 2-3 times a day to maintain effectiveness

n Nasal EPAP9,13 devices consist of disposable a one-way resister valve placed over the nostrils with an adhesive tapen The valves operate by utilizing the patient’s own breathing to

create a positive end expiratory pressuren Leads to upper airway dilation with subsequent tracheal

traction and increased lung volumes during exhalation

Treatment Options9


Quick recap…continued…n WINX9,14

n This device consist of a mouthpiece that is placed inside the oral cavity which connects by 2 been to a console

n The consul generates negative pressure (50 cm H2O)n Were negative pressure is applied in the mouth, uvula and

soft palate are pulled forward against the base of the tonguen The pharyngeal airway lumen is increasedn Based on limited data, the device can provide successful

therapy for ~30-40% of OSA patients

Travis Kit Baby, YEAH!


When in doubt, propose a study!n Writing deployment waivers led to an interesting question, what

is the definition of a “reliable power source”n By convention this was believed to mean a hard-wired, steady

power source expected at an established FOB

n Our team decided this shouldn’t be the only accepted reliable power source so we set out to show CPAP batteries could function as a reliable power source with minimum access to a hard-wired, steady power sourcen Limited study (n=3) diagnosed with OSA

n Each Airman issued two CPAP machines, all the supplies, and two batteries for each CPAP machine



When in doubt, propose a study!n The study participants were tasked to trial and record

n How long does one battery take to charge?n How long can each CPAP machine function on one fully

charged battery?n Can a battery be charged while the CPAP machine is being

used?n If the battery cannot be charged fully, what is the minimum

charge time needed for 1 full night of CPAP use?n If humidity feature is used, how much more reduced is the

battery during a full night CPAP use as compared to no humidity feature used during a full night CPAP use?



What were our results?n How long does one battery take to charge?

n Participants recorded that 2-3 hours was required to fully charge a battery, but two batteries could be charged at the same time if one was connected to a charger and the other connected to the CPAP machine

n How long can each CPAP machine function on one fully charged battery?n On average, participants recorded 1 fully charged battery

could operate their CPAP machine between 2-3 days

n Can a battery be charged while the CPAP machine is being used?n As noted above, yes a battery can be charged while CPAP

machine is being used



What were our results?n If the battery cannot be charged fully, what is the minimum

charge time needed for 1 full night of CPAP use?n On average, participants recorded that 1 hour of discharge

time could operate the CPAP machines for a little more than one night (7-9 hrs)

n If humidity feature is used, how much more reduced is the battery during a full night CPAP use as compared to no humidity feature used during a full night CPAP use?n Unfortunately, the participants identified that the humidity

feature reduced 1 fully discharged battery to only about 1 full night of CPAP use (5-7 hrs)



What’s the impact?n US Military members can now have a reliable power source with

just access to any generator about once or twice a week depending on the number of batteries they carry

n Col Elsayed von Bayreuth, TSgt Ryan Padgett and I presented our findings to several hundred NATO medical colleagues at the 2018 Aerospace Medicine Summit and NATO Science and Technology Organization at Ramstein AB, Germany

n This was very well received by all and we received several requests to use our findings as part of some other similar studies being conducted in three partner countries

n Deputy Surgeon General, Major General (Dr.) Sean Murphy, who also attended the summit, expressed his interest in pursuing CPAP batteries for future deployers

Travis Kit Success Stories


What’s the real impact?n After presenting our findings to several command surgeons and

publishing articles in several papers, we saw our first contact byan Army soldiern The soldier applied for a waiver to an unnamed location in

Africa which was deniedn The member contacted us via LinkedIn and we provided him

with our supply kit information and instructions for his PCM to request issue of his CPAP machine’s batteries and suppliesn While Tricare did not approve him to receive a second CPAP

machine, he was issued four batteries for his current CPAPn The member’s PCM once again submitted a waiver indicating

the member was issued batteries for his CPAP machine and this subsequent waiver was approved

What’s Next?


New areas?n TSgt Ryan Padgett was so happy and excited about this project

that he immediately began working with us on a smaller, more portable CPAP machine which made it much easier for aircrew to use it on long flights while sleepingn A recent article on Military.com article (31 Dec 19) highlighted

that Tricare is now covering portable CPAP machines to service members is being deployed or travels on official business at least three days a month

n A Tricare official stated, “With deployments and frequent travel, having a portable CPAP device would increase compliance and medical readiness.”

What’s Next?


New areas?n As mentioned, several NATO parties expressed interest in the

Travis Kit and one had recently completed a study that demonstrated aircrew members who flew at high altitudes and people who worked in extremely high altitudes such as mountains, experienced symptoms like those diagnosed with OSA

n The research team completed a study comparing these individuals with individuals who were diagnosed with OSAn Their findings showed oxygenation levels while sleeping in

high altitudes were almost exactly the same as someone with untreated OSA

n They plan to begin a second part to the study by having high altitude workers sleep with a CPAP machine to see if they can achieve the same results as we do with OSA

Tracer Case


n A 37 yo Male EOD technician reports to your clinic with complaints of daytime somnolence and a long history of snoring so loud, “I often wake my neighbors who live two houses down.”n What questions do we need to ask?n What exams should we complete?n Do we refer this member for a study? If yes, which is best?

Tracer Case


n Member returns to your clinic with then results from his split-night PSG which identified his AHI at 37/hr.n What is his OSA severity?n Does this member require an IRILO?n If this member was a flyer, when he require an aeromedical

waiver?n What things can we do to prepare this member for apossible

deployment?

Tracer Case


n Member returns to your clinic after using his CPAP machine for 3 months.n What questions do we need to ask this member now?n If the member states that he is being considered for a

deployment to a data masked location with a minimal footprint, what are some options we have to help thismember get approved for a deployment waiver?

In Review


What you hopefully learned from this…n Identify signs, symptoms, and high-risk populations for OSA

n Reviewed available clinical screening and outcome assessment tools

n Reviewed fitness for duty and deployment restrictions forAD personnel

n Reviewed various treatment methods of OSA

n Reviewed the “Travis Kit” findings for use in deployed “Austere” environments with “non-reliable” power sourcesn Reviewed Travis Kit success stories?

n Discussed future areas of research regarding CPAP machines/batteries

Sleep Apnea: Is it time toretire?


QUESTIONS?

Refrences


1. Kline, Louis R. “Clinical Presentation and Diagnosis of Obstructive Sleep Apnea in Adults.” UpToDate, Wolters Kluwer, 9 Aug. 2019, www.uptodate.com/.

2. Gamaldo, Charlene, et al. “Evaluation of Clinical Tools to Screen and Assess for Obstructive Sleep Apnea.”Journal of Clinical Sleep Medicine, vol. 14, no. 07, 2018, pp. 1239–1244., doi:10.5664/jcsm.7232.

3. Kapur, Vishesh K., et al. “Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline.” Journal of Clinical Sleep Medicine, vol. 13, no. 03, 2017, pp. 479–504., doi:10.5664/jcsm.6506.

4. Chung, Frances, et al. “STOP Questionnaire.” Anesthesiology, vol. 108, no. 5, 2008, pp. 812–821., doi:10.1097/aln.0b013e31816d83e4.

5. Weaver TE, Laizner AM, Evans LK, Maislin G, Chugh DK, Lyon K, Smith PL, Schwartz AR, Redline S, Pack AI, Dinges DF. An instrument to measure functional status outcomes for disorders of excessive sleepiness. Sleep 1997; 20:835-43

6. USAF. “USAF Medical Standards Directory.” Kx.health.mil, Air Force SG3, 10 Sept. 2019, kx.health.mil/kj/kx4/FlightMedicine/Documents/Medical%20Standards%20Directory%20(MSD)/2019/MSD%20Sep%202019%20FINAL%20v2.pdf.

7. United States, Congress, CENTCOM, and CENTCOM. “MOD14-TAB A: AMPLIFICATION OF THE MINIMAL STANDARDS OF FITNESS FOR DEPLOYMENT TO THE CENTCOM AOR.” MOD14-TAB A: AMPLIFICATION OF THE MINIMAL STANDARDS OF FITNESS FOR DEPLOYMENT TO THE CENTCOM AOR, vol. 14, CENTCOM, 2019, pp. 1–12.

8. United States, Congress, AFRICOM, and AFRICOM. “ACI 4200.09A FORCE HEALTH PROTECTION REQUIREMENTS AND MEDICAL GUIDANCE FOR ENTRY INTO THE U.S. AFRICA COMMAND THEATER.” ACI 4200.09A FORCE HEALTH PROTECTION REQUIREMENTS AND MEDICAL GUIDANCE FOR ENTRY INTO THEU.S. AFRICA COMMAND THEATER, vol. J004, AFRICOM, 2019, pp. 1–49.

http://www.uptodate.com/

Refrences


9. Lorenzi-Filho, Geraldo, et al. “Treating OSA: Current and Emerging Therapies beyond CPAP.” Respirology, vol. 22, no. 8, 2017, pp. 1500–1507., doi:10.1111/resp.13144.

10. Kushida CA, Littner MR, Hirshkowitz M, Morgenthaler TI, Alessi CA, Bailey D, Brown TM, Coleman J Jr, Friedman L, Kapen S et al.; American Academy of Sleep Medicine. Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders. Sleep 2006; 29: 375–80.

11. Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical practice guideline for the treatment of obstructive sleep apnea and snoring with oral appliance therapy: an update for 2015. J. Clin. Sleep Med. 2015; 11: 773–827.

12. Safiruddin F, Vanderveken OM, de Vries N, Maurer JT, Lee K, Ni Q, Strohl KP. Effect of upper-airway stimulation for obstructive sleep apnoea on airway dimensions. Eur. Respir. J. 2015; 45: 129–38.

13. Braga CW, Chen Q, Burschtin OE, Rapoport DM, Ayappa I. Changes in lung volume and upper airway using MRI during application of nasal expiratory positive airway pressure in patients with sleep disordered breathing. J. Appl. Physiol. (1985) 2011; 111: 1400–9.

14. Colrain IM, Black J, Siegel LC, Bogan RK, Becker PM, Farid- Moayer M, Goldberg R, Lankford DA, Goldberg AN, Malhotra A. A multicenter evaluation of oral pressure therapy for the treatment of obstructive sleep apnea. Sleep Med. 2013; 14: 830–7.