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Distributions of OSA Therapy Outcomes Based on a Trial Oral Appliance and/or Supine Avoidance

Authors:

Abstract

The study characterizes treatment outcome responder phenotypes using oral appliance therapy and/or supine avoidance.
2019 Clinical Research Award recipient of the American Academy of Dental Sleep Medicine, San Antonio, Tx
Distributions of OSA Therapy Outcomes Based on a Trial Oral Appliance and/or Supine Avoidance
Daniel Levendowski MBA1, Dominic Munafo MD2, Samuel J Clark MD2, Bretton Hevener RPSGT2,
Dorian Cruz Arista CDA2, Todd Morgan DMD3
1Advanced Brain Monitoring, Carlsbad, CA, 2Sleep Data, San Diego, CA, 3Sleep Alliance, San Diego, CA
Introduction: A previous cross-over study design reported that the combination of oral appliance (OA) and position
therapies was more effective than either therapy used individually.1 This study assessed the distributions of potential
outcomes from oral appliance (OA) therapy and/or supine avoidance using a two-night home sleep apnea test (HSAT)
and a Trial OA.
Methods: One-hundred and fifty-two adult patients with a diagnostic AHI >5, 54+12.8 years, and 40% female
were included in this retrospective analysis. All patients were fitted with a Trial OA (Apnea Guard®, Advanced
Brain Monitoring, Carlsbad, CA) to assess the likelihood of response to OA therapy. The Trial OA was advanced
to 70% of the distance from neutral bite to maximum protrusion, with females delivered either 5.5 or 6.5 mm
vertical dimension of occlusion (VDO) and males fitted with a 6.5 or 8 mm VDO depending on tongue scalloping.2
A two-night HSAT (NightOne, Philips Healthcare, Monroeville PA) was performed at Baseline on night one and with the
Trial OA on night two. Response to the Trial OA required an AHI reduction >30% for those with a pre-treatment AHI
<20, and >40% reduction in those with a pre-treatment AHI >20. Positional OSA (POSA) was characterized when the
overall AHI/non-supine AHI > 1.4 and >20 minutes in both supine and non-supine positions.3 Patients who slept <20
minutes non-supine were characterized as supine dominant. Two-tailed Chi-squared and t-test analyses were used to
identify group differences.
Results: Sixty-six percent of the patients were identified as responders with the Trial OA (100/152). Prior to OA
treatment, the prevalence of POSA (when it could be determined) was 70% of those who subsequently responded to
the Trial OA and 48% in non-OA responders (p<0.02). The odds of a patient with POSA being an OA responder was 2.5
(p<0.02, 95% CI range 1.2-5.4).
Patients were then stratified into one of four phenotypes based on response to OA and/or having POSA, resulting in
the following distributions by group:
OA Responder with: Proportion Non- OA Responder with: Proportion
1. No residual POSA
41%
3. Positional OSA
14%
2. Residual POSA
25%
4. Non-positional OSA
20%
Forty-one percent of the patients responded to the Trial OA with no residual POSA (Type 1)(62/152); 20% achieved an
efficacy equivalent to CPAP (i.e., AHI <5 events/h) and 32% of the cohort had an AHI < 10 events/h (Fig. 1).
Twenty-five percent of those who exhibited a response to the Trial OA either had residual POSA or were Supine
Dominant (Type 2). Based on the non-supine AHI, if the Trial OA was combined with supine avoidance, 16% of the
cohort could achieve an additional 60+21% reduction in overall AHI (Fig. 2.a.), with 14% having an non-supine AHI <5
events/h. OA responders who were supine dominant and would likely benefit from supine avoidance occurred in 9%
of the cases (Fig. 2.b.).
Fig. 1
Apnea Guard
2019 Clinical Research Award recipient of the American Academy of Dental Sleep Medicine, San Antonio, Tx
In the patients who did not respond to the Trial OA (Type 3), the Baseline HSAT identified POSA in 11% of the cases
(Fig. 3.a.). If supine avoidance was provided as an alternative to a Custom OA in this group, a mean reduction in
overall AHI of 66 + 20% could be achieved; eight patients would have an AHI < 5. Four OA non-responders were non-
POSA at baseline but converted to POSA after introduction of OA therapy (Fig. 3.b.). The combination of OA plus
supine avoidance in this sub-group could have reduced the overall AHI by 65 + 24%.
Only 20% of the patients would likely not be effectively treated with either an OA and/or supine avoidance (Type 4)
(Fig. 4). Patients who did not respond to the Trial OA and were non-POSA (Type 4) had significantly greater body fat as
compared to those who responded to OA with no residual POSA (Type 1)( p < 0.003, 28.7+5.1 vs. 32.9+8.0) (Fig. 5).
Conclusions: The combination of oral appliance and/or supine avoidance therapies could effectively treat 80% of the
patients (all but Type 4) with 39% potentially achieving an outcome equivalent to CPAP (i.e., AHI <5). Based on the
Trial OA, approximately 66% of patients would benefit from OA therapy (Types 1 & 2) and 39% could benefit from
supine avoidance (Types 2 and 3). Patients with POSA are more likely to respond to OA therapy, a finding consistent
with a previous report.4
Fig. 2.b.
Fig. 2.a.
Fig. 3.a.
Fig. 4
Fig. 3.b.
Fig. 5
References:
1. A randomized, controlled trial of positional therapy versus oral appliance therapy for position-dependent sleep apnea. Benoist L, de Ruiter M, de Lange et al. Sleep
Med 2017; 34: 109-117
2. Initial evaluation of a titration appliance for temporary treatment of obstructive sleep apnea. Levendowski D, Morgan T, Westbrook P, J Sleep Disord Ther 2012; 1(1)
3. A systematic comparison of factors that could impact treatment recommendations for patients with Positional Obstructive Sleep Apnea (POSA). Levendowski D,
Oksenberg A, Vicini C et al. Sleep Med 2018; 50: 145-151
4. Patients with positional versus nonpositional obstructive sleep apnea: a retrospective study of risk factors associated with apnea-hypopnea severity. CHung J,
Enciso R, Levendowski D, et al. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2010; 110: 605-610.
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