Faculty/Presenter Disclosure

• Faculty/Presenter: Wilfred J. Alonso • Relationships with commercial interests:

– Grants/Research Support: Not applicable – Speakers Bureau/Honoraria: Paladin Pharmaceuticals, Valeant

Pharmaceuticals – Consulting Fees: Paladin Pharmaceuticals – Other: Not applicable

CFPC COI Template - Slide 1

ACFP 60th ASA Disclosure of Commercial Support • This program has received financial support in the form of sponsorship from:

Alberta Medical Association RHS Canada/The Snore Centre Aspen Pharma Scotiabank Purdue Pharma VitalAire University of Calgary Health Quality Council of Alberta Alberta Health Services eReferral Janssen Eli Lilly

• This program has received in-kind support from The Rimrock Resort Hotel in the form of a contribution to food/beverage at the Thursday Research Poster Presentations and Welcome Reception.

• Potential for conflict(s) of interest:

– Those speakers/faculty who have made COI disclosure are noted in the 60th ASA Program and on the Salon A/B slide scroll.

CFPC COI Template - Slide 2

Mitigating Potential Bias • ACFP:

→ The ACFP’s Sponsorship Guidelines apply to ASA Sponsorship. The ACFP abides by the Canadian Medical Association’s Policy Guidelines for Physicians in Interactions With Industry and the Rx&D Association’s Rx&D Code of Ethical Practices. As a non-profit organization, the ACFP complies with Canada Revenue Agency regulations. When considering acceptance of sponsorship, the ACFP considers and accepts sponsorship only from those whose products, services, policies and values align with the ACFP vision, values, goals and strategies priorities.

• ASA Planning Committee: → Consideration was given by the 60th ASA Planning Committee to identify when

an speaker’s personal or professional interest may compete with or have actual, potential or apparent influence over their presentation.

→ Material/Learning Objectives and/or session description was developed and reviewed by a Planning Committee composed of experts/family physicians responsible for overseeing the program’s needs assessment and subsequent content development to ensure accuracy and fair balance.

→ The 60th ASA Planning Committee reviewed Sponsorship Agreements to identify any actual, potential or apparent influence over the program.

→ Information / recommendations in the program are evidence- and / or guidelines-based, and opinions of the independent speakers will be identified as such

CFPC COI Template - Slide 3

W. JEROME ALONSO, MD, CCFP, DABFM (CERT. SLEEP MEDICINE) MEDICAL DIRECTOR, CANADIAN SLEEP CONSULTANTS BOARD CERTIFIED IN SLEEP MEDICINE – AMERICAN BOARD OF MEDICAL SPECIALTIES FEBRUARY 28, 2015

Tricks and Traps to Silence the Bear: Non-CPAP Therapies for Obstructive

Sleep Apnea

Outline Significance of Obstructive Sleep Apnea Brief Diagnostic Methods for Obstructive Sleep Apnea Conventional PAP therapy Non-PAP based therapies

Mandibular Advancement Devices Surgical Options EPAP devices Non-conventional modalities

Situations where PAP therapy is less appropriate or possible harmful

Obstructive Sleep Apnea

Prevalence =24% men; 9% women (Young 1993); EDS = 9% men and 4% of women.

OR of fatal CV in Severe OSA= 3.17; OR non-fatal = 2.87 (Marin, JM 2005)

Associated fatigue, daytime sleepiness and decreased QOL

Obstructive Sleep Apnea

High-risk populations: 50-80% of obese with OSA (Young 2005) 75% of HTN patients with 3 or more medications 1/3 to 2/3 of geriatric population (Ancoli-Israel 1991) 2.6 fold increase in post-menopausal women (Young

2003); 1 : 1.44 ratio versus 1 : 3.3 (Bixler 2001) 2.3 fold increased likelihood of DM in those with OSA 50% of those with PCOS will have OSA (Vgontas 2001)

Diagnostic modalities

Level 3 – Ambulatory polysomnography Nasal flow, pulse oximetry, +/- effort

channels, +/- microphone Level 1 – In-lab nocturnal

polysomnography EEG, EMG, EOG, nasal flow, microphone,

effort channels, EKG

CPAP Therapy

Highly Effective; Most common method Associated with decreased CV risk as

compared to untreated OSA Typically covered by extended healthcare

plans

Approximately 54% compliance rate after 5 years (Wolkove, N 2008)

Are there other treatment options for our

patients?

Mandibular Advancement Devices

http://www.somnomed.com/Products/SomnoDent.aspx

http://tapintosleep.com/tap-3-elite/

Mandibular Advancement Devices

Improves airway by altering jaw and tongue base position Recommended primarily for mild to moderate obstructive sleep apnea

(Apnea Hypopnea Index of 5-15 events per hour) Has approximately 48% success in reducing AHI to less than 5/hour

(Sutherland, K 2014) 4mm advancement at the level of the base of the tongue. Demonstrated to be effective in reducing objective sleepiness

(Gotsopoulus 2008) Meta-analysis demonstrating equivalent reduction as compared to

CPAP (Lim, J 2009) Up to 70% may have a change in their bite in 5 years Changes in occlusion is negligible in up to half(Almeida FR 2006)

http://www.zephyrsleep.com/Products.aspx

http://www.zephyrsleep.com/Products.aspx

Surgical Management

Surgical procedures as an approach Main appeal:

Potential cure Main Categories:

Soft tissues approaches Oromaxillofacial approaches

Surgical approaches: Stanford phased protocol Surgical categories in isolation

Soft Tissue surgery

Uvulopalopharyngoplasty Surgical procedure that has been present for the past

25 years 40% success rate (Sher, AE 1996) Side effects: Velopharyngeal insufficiency, stenosis, dyphagia

Uvulopalatal flap Similar effectivity to the UPPP (Powell, NB 1996) Demonstrated to decreased pain on VAS scale

Soft Tissue surgery

Other surgeries: Genioglossus advancement Hyoid Suspension Radiofrequency ablation of the tongue Nasal surgeries

LAUP and Surgical Pillar procedures are not considered OSA surgeries by the AASM

Maxillomandibular Advancement Surgery

Long-term success of approximate 90% (Li, KK 2000) Very good patient perception of outcome (Li, KK 2000) Considerations:

Long orthodontic preparation

High cost in Alberta

3 weeks of a liquid diet

3 month before being able to bite into hard foods

Change in appearance

Side effects:

Maxillomandibular advancement

http://www.sleepapneasurgery.com/maxillomandibular_advancement.html

Expiratory Positive Airway Pressure (e.g. Provent, Theravent)

Expiratory Positive Airway Pressure (e.g. Provent, Theravent)

Berry, R et al. Sleep 34(4). 2011

Prospective, multi-centre, sham-controlled, parallel-group, randomize, double-blind, clinical trial

EPAP device (N=127) versus sham EPAP (N=123) for 3 months Inclusion: AHI >10; Age >19 Exclusion: Severe nocturnal arterial oxygen desaturation, previous upper

airway surgery, nasal occlusion, or previous treatment with CPAP or an oral appliance were excluded.

Median baseline AHI: EPAP = 13.8 (5.3, 22.6) ; Sham =11.1 (4.8, 21.8) At week 1, median AHI value was significantly lower with EPAP (5.0

versus 13.8 events/h, P < 0.0001) but not sham (11.6 versus 11.1 events/h, P = NS)

Over 3 months, Epworth Sleepiness Scale decreased (9.9 ± 4.7 to 7.2 ± 4.2, P < 0.0001).

Berry, R et al. Sleep 34(4). 2011

Prospective, multi-centre, sham-controlled, parallel-group, randomize, double-blind, clinical trial

EPAP device (N=127) versus sham EPAP (N=123) for 3 months Inclusion: AHI >10; Age >19 Exclusion: Severe nocturnal arterial oxygen desaturation, previous

upper airway surgery, nasal occlusion, or previous treatment with CPAP or an oral appliance were excluded.

Median baseline AHI: EPAP = 13.8 (5.3, 22.6) ; Sham =11.1 (4.8, 21.8)

Expiratory Positive Airway Pressure (e.g. Provent, Theravent)

Not effective in RCT in patients with Moderate to Severe Obstructive sleep apnea (Rossi, V. Thorax. 2014) RCT 67 Subjects with prior OSA effectively treated on CPAP(Ave RDI in all

arms >30 events/hour)

3 Arms – 1) Automatic CPAP; 2) Provent; and 3) sham Provent

No difference in Provent versus Sham in ODI, AHI or ESS (Sleepiness). Higher in all parameters versus CPAP with recurrence of OSA.

Not effective in RCT in patients with Moderate to Severe Obstructive sleep apnea (Rossi, V. Thorax. 2014) RCT 67 Subjects with prior OSA effectively treated on CPAP(Ave RDI in all

arms >30 events/hour)

3 Arms – 1) Automatic CPAP; 2) Provent; and 3) sham Provent

No difference in Provent versus Sham in ODI, AHI or ESS (Sleepiness). Higher in all parameters versus CPAP with recurrence of OSA.

Not effective in RCT in patients with Moderate to Severe Obstructive sleep apnea (Rossi, V. Thorax. 2014) RCT 67 Subjects with prior OSA effectively treated on CPAP(Ave RDI in all

arms >30 events/hour)

3 Arms – 1) Automatic CPAP; 2) Provent; and 3) sham Provent

No difference in Provent versus Sham in ODI, AHI or ESS (Sleepiness). Higher in all parameters versus CPAP with recurrence of OSA.

Esoteric Treatment Adjuncts

Digeridoo Speech Therapy exercises Positional trainers

Considerations for therapy

Severity of condition Success rate of procedure Cardiovascular risk reduction

Potential side effects of treatment Patient pre-treatment acceptance Clinical symptomology both before and after

treatment

Conclusion

There are a number of treatment modalities available for the treatment of OSA

Informed consent is important because of the low compliance to CPAP in the long-term

A collaborative approach is ideal with physicians still maintaining the role of guiding our patients to an acceptable long-term treatment option