Rochelle Goldberg, MD, FCCP, FAASM

Diplomat, American Board of Sleep Medicine

Director, Sleep Medicine Services

Main Line Health

Lankenau Medical Center and Paoli Hospital

PAP Compliance

and

When All Else Fails

Disclosures

• Speaker: Teva, UCB, Purdue

• Advisory Board: Welltrinsic Sleep Network

• Consultant: Vapotherm, Inc.

• National Interpretor: Novasom

Compliance: The Dirty Secret • Medical Treatment

Acute illness:

• 20-40%

• Chronic illness:

• 30-60%

• Prevention:

• 80% Christensen AJ, Current Perspectives

in Psychology2004.

PAP Compliance

50 % of patients

discontinue CPAP in

the first year. Collen J et al: Chest 2009;135:704

46-83% of patients are

non-compliant;

defined by PAP < 4

hours/ night. Weaver TE, Proc Am Thorac Soc.

2008

PAP Compliance and CMS • Guidelines

– > 4 hours per night

– > 70% of nights

– Days 31-90

Most commercial

plans have adopted

same guidelines

• Benefits and

limitations

• Availability of

objective date,

emphasis on this

• Does not allow

leeway (clinical

realities)

Predictors: Good Compliance • Older patient, female

• Severe OSA (>30/hour)

• Early benefit (<7 days); improved sleepiness

• Mask comfort, humidification

• Partner support

• Health care support/education

• Behavioral readiness to change

• Self-management of chronic illness --SmithI, Cochrane Database of Systematic Review 2004; 4. Art. No.

CD003581.

Predictors: Poor Compliance Young and/or single adult

Mild OSA; high PAP level

Limited education on diagnosis and treatment

Limited partner, family support

Claustrophobia

Ongoing symptoms

Depression, dementia, language barrier

Denial- no “ownership of the problem”

Side effects (skin irritation, nasal congestion) --Smith I, Cochrane Database of Systematic Review 2004; 4. Art. No.

CD003581.

Non-CPAP Treatment of Sleep

Apnea: What are the Options?

• Behavior

• Devices

• Surgery

• Oxygen and Drugs

Behavioral Treatment

• Weight loss

• Avoidance of supine sleep

• Smoking cessation

• Avoidance of muscle relaxants

• Avoidance of sleep deprivation

• Exercise

• Playing a musical instrument

Question 1:

Which of the following is most correct about

behavioral treatments for sleep apnea?

A. There are no other effective treatments besides PAP

therapy.

B. Weight loss may result in significant improvement in

apnea.

C. Sedative medications may help improve sleep apnea.

D. Voice training may strengthen the upper airway.

Weight Loss for OSA

• 65% of Americans are overweight or

obese (Flegal KM, JAMA 2010)

• Only 1 in 6 adults reports maintaining a

10% weight loss for 1 year (Kraschnewski JL,

Int J Obes 2010)

• Modest (10%) weight loss results in

significant improvement in AHI (Yee BJ, Int J

Obes 2006)

CPAP Users Gain Weight (Quan SQ JCSM 2013) • N

Weight change

at 6 months

active vs.

sham CPAP Apples

trial (n=812,

p<0.001)

Change in Weight and RDI (Newman AB Arch Intern Med 2005, SHHS)

Which Weight Loss Program is Best?

RCT of 658 obese individuals.

Weight Watchers

Slimming World: group-based, community-set; 90 minute sessions with

goals set by participant; website access, awards for achievements

Rosemary Conley: group-based, community-set; 90 minute sessions with

goals set by participant

Size Down: NHS program in community with dietetic workers; 6 weekly 2

hour session, f/u 9 and 12 wks.

General practice and pharmacy: 12 one-to-one sessions, with education,

goals, motivation.

Comparator/Exercise: vouchers for 12 free exercise sessions at a local

leisure center. --JollyK, BMJ 2011

Conclusions/Caveats

• All programs resulted in significant weight loss at

12 weeks.

• Only the commercial programs resulted in

significant weight loss at one year.

• Commercial programs were less expensive than

primary care programs.

• The greatest weight loss was with Weight

Watchers.

• Weight Watchers funded the study.

Bariatric Surgery Improves

Comorbidities(Dumon K Surg Clin NA 2011)

• AGB (LAGB)-adjustable gastric banding

• RGB (RYGB- Roux-en-Y gastric bypass (most common

procedure, by far)

• BPD (DS) biliopancreatic diversion + duodenal switch

• LSG-laparoscopic sleeve gastrectomy

Bariatric Surgery or

Conventional Weight Loss? • Laparoscopic gastric bypass is probably surgical treatment of

choice

• Complications are significant

– 10% morbidity/ 1% mortality

• Bariatric Surgery results in 75-88% cure rate of OSA at 1 year, independent of approach

--GuardianoSA, Chest 2003; CrooksPF, Ann Rev Med 2006

• Surgical group lost more weight (28kg) than diet (5kg) but improvement in AHI was not statistically significantly different (-28 vs -11 events/hr)

-- Surgical vs conventional therapy for weight loss.Dixon, JAMA 2012

Sleeping Position and OSA

• Up to 50% of patients have position-dependent

OSA. These patients may be thinner, milder,

younger. --Richard W Eur Arch Otolaryngol 2006

• Position-dependent OSA may be defined as a

difference of 50% or more in AHI between

supine and non-supine positions.

Positional Therapy

• Snoring-reduced in non-apneic patients, but not in apneic

ones. (7 studies; 118 pts)

• OSA- all studies show “positive effect” on AHI, and self-

reported compliance is better than CPAP.(16 studies; 293 pts)

• Side effects: backache, discomfort, no benefit.

--Ravesloot MJL Sleep Breath 2012

• Positional therapy is an effective secondary RX or can be a

supplement to primary therapies for OSA in patients who

have a low AHI in the non-supine position.

• --Practice Parameters for Medical Therapy of OSA, MorganthalerT Sleep

2006

Cigarette Smoking and OSA

• Most data indicates relationship.

• Second-hand smoke appears to be a

risk for snoring.

–FranklinKA, AJRCCM 2004

• Ex-smokers do NOT appear to have

increased risk for OSA.

• Parental smoking appears to be a

risk for SDB in children.

–KadatisAG, Ped Pulm 2004; SnowA, Ped

Pulm 2009

Alcohol and OSA

“Most but not all studies … have

demonstrated harmful effects on

nocturnal respiration, including

increased number and duration of

hypopnea and apnea events.”

--Young T, AJRCCM 2002

Sleep Deprivation and OSA

• Sleep deprivation does not consistently

worsen sleep apnea. --Desai AV Sleep 2003, n=39

• Sleep deprivation worsens SDB.

--Series F AJRCCM 1994, n=8

• Treated OSA patients drive as safely as

controls, but are worse after sleep

deprivation. --Filtness AJ Sleep Med 2011, n=19

OSA: Sleep Deprivation and Alcohol (Vakulin A Ann Intern Med 2009 n=58)

For sleep-deprived vs not

For alcohol vs not

Exercise for OSA

• 4275 SHHS participants

• > 3 hrs/week of self-reported vigorous

exercise reduced risk of AHI > 15

• Similar but weaker associations for less

vigorous exercise or different definitions of

OSA --Quan SF, Sleep Breath 2007

Exercise for OSA: Interventions

• RCT for 12 weeks (n=20)

– Exercise group-improved AHI, FOSQ, SF-35 but not

BMI compared with baseline, but not with control. -- Sengul YS Sleep Breath 2011

• Supervised exercise for 6 months (n=11) – Decrease in RDI (33 to 24), no change in BMI

--Biebelhaus KP Sleep Breath 2000

• Supervised exercise for 6 months (n= 9) – Decrease AHI,improved sleep, reduced BMI

--Norman JF Sleep Res Online 2000

Playing a Musical Instrument

• Musicians playing a double reed

instrument** had reduced risk of OSA, by

Berlin score, compared to non-wind

instruments. Number of hours predicted

lower risk. --Ward CP JCSM 2012

• Digeridoo playing improved sleepiness

and AHI compared with not playing with

OSA in an RCT --Puhan MA BMJ 2006, n=25

Non-CPAP Treatment of Sleep

Apnea: What are the Options?

• Behavioral Changes

• Devices (OAT, EPAP, OPT)

• Surgery

• Oxygen and Drugs

Question 2 MC is a 55 year old woman followed for severe

sleep apnea. She is doing well with PAP but just

saw her dentist who recommended an oral

appliance (OAT). Which of the following would you

advise?

A. OAT is as effective as PAP for improving AHI.

B. Patients are more likely to adhere to PAP than OAT.

C. Side effects include jaw discomfort and bite changes.

D. She should try a boil and bite device first.

Indications for Oral Appliances (Kushida C, Sleep 2006)

– Primary snoring

– Mild to moderate OSA patients who:

• Prefer OAs to CPAP

• Do not respond to CPAP

• Are not appropriate candidates for CPAP

• Fail treatment attempts with CPAP or behavioral changes

– Patients with severe OSA should have an initial trial of

nasal CPAP [before considering OAs]

– Upper airway surgery may also supersede use of OAs in

patients for whom these operations are predicted to be

highly effective in treating sleep apnea

Rigid, Non-adjustable and

Movable, Adjustable Appliances

OAT: How it Works; Compliance

• 1 year compliance (48-

84%)

• 4 year compliance (62% and 76%) De Almeida, J Clin Sleep Med, 2005

OAT vs CPAP & UPPP

OAT v PAP

• CPAP is more

effective in

improving AHI

• Adherence was

better with the

OA.

• Pts preferred the

OA over CPAP.

OAT v UPPP

• 4 year success

– 50% decrease RDI

– OAT 81% v 53% UPPP

• Normalization

– AHI< 10, AI<5

– OAT 63% v 33% UPPP

• Compliance

– OAT 62%

– UPPP 75% (no further RX)

Side Effects of Oral Appliances • Very common; usually minor transient; resolve

quickly with appliance removal

• Dry mouth

• Increased salivation or drooling

• Tooth soreness or looseness

• Jaw or muscle discomfort

• Bite changes (jaw remains in forward position, improvement accelerated with squeezing back teeth together (chewing gum); repositioners

Oral Appliances: Summary Indicated for patients with mild-to-moderate

obstructive sleep apnea who prefer oral appliances to CPAP

do not respond to CPAP

are not appropriate candidates for CPAP

fail treatment attempts with CPAP (Kushida Sleep 2006)

Not as effective as CPAP

Lower blood pressure 3-4 mmHg (Otsuka Sleep Breath

2006; Yoshida K, Int J Prosthodont 2006)

Outperformed surgery in the only head-to-head trial.

Preferred to CPAP in head-to-head trials.

Caveats About OA’s

• They may not work as well for non-

position-depending sleep apnea (Lee

CH Arch Otolarngol Head Neck Surg

2012).

• Non-adjustable, “boil and bite” OA’s

do not work as well as custom-made

ones (Ahrens A, Eur J Orthodon,

2011)

Expiratory Positive Airway Pressure (EPAP) Mean BMI 32-34; mild to

moderate AHI

– EPAP reduced AHI from

13.8 to 5 at one week, and

from 14.4 to 5.6 at 3

months.

– Oxygenation also improved

– “Severe” subset : AHI fell

from 48 to 19

– Reported adherence 88%

– Note:1013 refused to

participate

--Berry, RB Sleep 2012

Oral Pressure Therapy (ApniCure)

Oral Pressure Therapy (WINX) Malhotra A et al, ATS 2012 ABSTRACT, n=60

Upper Airway Stimulation for OSA

Results, n=126 (Means/Medians, all significant)

Outcome Baseline 12 months

AHI 32/29.3 15/9.0

ODI 28.9/25.4 13.9/7.4

% time with Sa02<90% 8.7/5.4 5.9/0.9

FOSQ 14.3/14.6 17.3/18.2

Epworth 11.6/11.0 7.0/6.0

• Withdrawal

phase (n=46)

• Device turned off

for 5 days in 23

patients

• Means+SD, all

significant

Non-CPAP Treatment of Sleep

Apnea: What are the Options?

• Behavioral Changes

• Devices

• Surgery

• Oxygen and Drugs

Rationale for Surgical Treatment of Sleep Apnea

• Sleep apnea is prevalent (~5%, Young,

2002)

• Sleep apnea kills (needs treatment !)

• CPAP compliance is problematic

• Some individuals have physical

obstruction contributing to or causing the

sleep-disordered breathing (2% of adult

OSA patients, Sher)

Surgical Approaches to SDB • -nasal septal surgery

• -turbinate reduction surgery

• -Somnoplasty turbinate reduction

• -Uvulopalatopharyngoplasty

• -partial uvulectomy/ Pillar Procedure

• - CO2 laser palatoplasty (LAUP)

• -uvulopalatal flap

• -Woodson Procedure (transpalatal palatopharyngoplasty)

• -Somnoplasty - turbinate reduction - tongue base reduction - soft palate for snoring

• -adenoidectomy

• -Tonsillectomy (total/ partial)

• -lingual tonsillectomy

• -tongue base reduction

• -epiglottectomy

• -epiglottoplasty

• -glossectomy (anterior vs. posterior)

• -linguoplasty (CO2)

• -tongue-base suspension sutures (Repose procedure)

• -hyoid suspension and advancement to mandible

• -hyoid myotomy and suspension to thyroid cartilage

• Expansion hyoidplasty

• -geniotubercle/genioglossus skeletal advancement (with multiple variants)

• -jaw advancement (telegnathic) surgery (LeFort I, Bilateral Sagittal split Advancement Osteotomies)- ? Distraction Osteogenesis

• -maxillary transverse expansion

• -tracheostomy

• -hyoepiglottoplasty

• -Genioglossus electrical pacing (hypoglossal nerve stimulation)

Surgery and OSA: The History

“There is an urgent need for high quality randomised controlled trials to

be carried out in the field of surgery for obstructive sleep apnoea.” –

Cochrane, 2000

“ The studies assembled in the review do not provide evidence to support

the use of surgery in sleep apnoea/hypopnea syndrome, as overall

significant benefit has not been demonstrated…” –Cochrane, 2005

“The published literature is comprised primarily of case series, with few

controlled trials and varying approaches to preoperative evaluation

and post-operative follow-up…Further research is needed to better

clarify patient selection, as well as efficacy and safety of upper airway

surgery in those with OSA.”—Caples, Sleep 2010

“Surgical treatments are associated with risks and harms. Current

evidence evaluating surgery was limited and insufficient to show the

benefits of surgery as an approach to treat OSA; therefore, surgery

should not be used as an initial treatment of OSA.” -- ACP

CPG:Management of OSA in Adults, Ann Int Med 2013

Tracheostomy • The surgical “gold standard” for OSA

• Success 100% (Thatcher, 2003, n=79)

• Early cure in 83% – residual central apneas resolve over time

• Significant endpoints: – Sleepiness resolves in 82-100%

• 3 studies with 98 patients

– Hypertension improves or resolves

– Hypercapnia, cor pulmonale, and cardiac arrhythmias resolve

• Morbid procedure (Conway W, Jama 1981)

– Psychosocial problems,local granulation,recurrent bronchitis

Question 3 Which of the following is most correct

regarding UPPP treatment for sleep apnea? A. The success rate (reduce AHI by 50%) is over 75%.

B. The relapse rate (recurrence of OSA) is about 15%.

C. AutoPAP is preferred for patients failing UPPP.

D. Patients are less likely to accept PAP after UPPP

failure.

UPPP OUTCOMES SHORT TERM:

Mean decrease AI 55%; RDI 38%

Success: 60-67% (reduce AHI by 50%)

Complications: velopharyngeal insufficiency, post-op

bleeding, voice change, death

LONG TERM:

Success rate after > 4 years 44-50%

50% relapse rate (often related to weight gain)

Limited long term studies; limited comprehensive reports

of adverse events.

Maxillomandibular Advancement (MMA)

• Success rates >90%

– Carefully selected

patients

– Best outcomes in

patients with “birdlike”

facies (i.e. mandibular

deficiency

• Prinsell 2002

CPAP After Surgery: Long Term

Follow up • Compliance/acceptance are lower than non-

surgerical patients (Han F Sleep Breath 2006).

• Lower pressures may be required than pre-operatively.

• Higher pressures may be required.

• A chin strap or full face style masks may be required to prevent air leak.

• Autotitrating CPAP is contraindicated.

Non-CPAP Treatment of Sleep

Apnea: What are the Options?

• Behavioral Changes

• Devices

• Surgery

• Oxygen and Drugs

Oxygen Compared to CPAP

for OSA • Improves Sa02, but not sleep quality Loredo JS, Sleep 2006

• Improves Sa02, but does not lower blood

pressure Norman D, Hypertension 2006

• Improves Sa02 and neuropsychological

tests, but does not improve MSLT

Phillips B, Chest, 1988

Drugs for OSA

“There is insufficient evidence to recommend the use of drug therapy in the treatment of OSA. For fluticasone, mirtazipine, physostigmine and nasal lubricant, studies of longer duration are required to establish whether this has an impact on daytime symptoms. It is likely that better matching of drugs to patients according to the dominant mechanism of their OSA will lead to better results and this also needs further study.”—Cochran 2006

Practice Parameters for Medical

Therapy of OSA (Morganthaler T Sleep 2006)

• SSRI’s, protriptyline, xanthines, estrogen are not recommended.

• Modafinil is recommended for Rx of residual daytime sleepiness in OSA patients who have sleepiness despite effective PAP Rx and who are lacking any other identifiable cause for their sleepiness.

• Oxygen supplementation is NOT recommended as a primary treatment for OSA.

• Topical nasal steroids may improve AHI in those with rhinitis.

Non-PAP Treatment for OSA: Bottom Line

• Even modest weight loss helps. Bariatric surgery

provides most evidence for weight loss effects on

OSA.

• Oral appliances are now vetted as reasonably

effective second-line Rx.

• Stay tuned on newer devices and treatments.

• MMA may be effective in very carefully selected

patients.

• Oxygen improves oxygenation, but not much else.

• Drugs are not appropriate as monotherapy.