In-home evaluation of efficacy and titration of a mandibular advancement device for obstructive sleep apnea

There is increasing evidence that mandibular advancement devices (MADs) can be an effective treatment for some patients with obstructive sleep apnea, a highly prevalent chronic disease. In this study, the objectives were to objectively assess the effectiveness of MAD therapy using a limited channel recorder, and to develop a model for identifying patients who may be appropriate for MAD therapy as the initial treatment option. Thirty patients were prospectively recruited and studied at two independent dentist offices and the participants’ homes. Subjects wore the ARES Unicorder for two nights before insertion of the MAD, and again when the dentist determined that the patient had reached the titration endpoint. Self-reported measures of depression, sleepiness, and quality of life were obtained pre- and posttreatment. The reviewer was blinded to the study status while the physiological signals were being visually inspected. Significant reductions in the apnea/hypopnea index (AHI), hypoxemia measures, and snoring level were observed posttreatment. Twenty-seven of the 30 (90%) patients had a posttreatment AHI (using a 4% desaturation for hypopneas) below a clinical cut-off of 10. All but one patient (97%) exhibited at least a 50% decrease in AHI or had a posttreatment AHI ≤ 10. Significant differences in body mass index, weight, and neck circumference in patients with posttreatment AHIs above and below a clinical cut-off of five were identified. The linear regression used to predict the posttreatment AHI using pretreatment data resulted in an R2 of 0.68. The model correctly predicted two patients who were unable to obtain a posttreatment AHI of 10 or less. This study was designed to demonstrate two models of collaboration between a dental sleep medicine specialist and a sleep medicine physician in the monitoring of a patient treated with a MAD. The outcome data suggest that the limited channel recording system can be used as an alternative to laboratory polysomnography to reduce the cost of MAD treatment, and to improve the quality and consistency of posttreatment patient care

P078 Oral Appliance Fabrication Settings Impact Treatment Efficacy

Abstract Purpose Assess the impact of custom oral appliance (CA) fabrication settings on treatment outcomes. Methods CPAP-intolerant patients completed a two-night home-sleep-apnea study (HSAT); Night1=baseline, Night2=Apnea Guard® trial appliance (AG). The AG vertical-dimension-of-occlusion (VDO) selection was based on tongue-scallop (women=5.5/6.5 mm, men= 6.5/8.0 mm), with a target protrusion of 70% from neutral-maximum while in situ. Study1 CA VDO was dependent on sex (women=2.5 mm, men=5 mm), with protrusion set using a George-Gauge measured 70% from maximum retrusion-protrusion with dentist-directed titration. Study2 CA was fabricated to the AG VDO and target protrusion bite-registration. Efficacy HSATs were conducted after completion of Study1 CA titration with vertical-elastics optional, and at the AG target protrusion with vertical-elastics mandatory in Study2. Statistics included Mann-Whitney, Chi-squared, and Bland-Altman analyses. Results The Study1 (n=84) and Study2 (n=46) distributions were equivalent for tongue-scallop (64/63%) and sex (women=45/41%), however, noted differences in age (53.8±11.9 vs. 58.4±12.2; P=0.052), body-mass-index (29.4±5.7 vs. 27.8±4.0; P=0.128) and pre-treatment AHI severities (24.6±14.4 vs. 29.2±17.4 events/h; P=0.155) were observed. The Bland-Altman biases were significant different (Study1=4.2±7.8 vs. Study2=1.3±7.0 events/h, P=0.035). The significant Study1 differences between the CA vs. AG AHIs (12.3±9.2 vs. 8.2±5.9 events/h, P&amp;lt;0.0002) were not apparent in Study2 (11.7±8.0 vs. 10.4±6.7 events/h, P=0.362), however, the Study2 AG AHI values were higher (P=0.055). Discussion Despite the trend toward greater Study2 pre-treatment and AG AHI severities, CA treatment efficacy was equivalent to the AG once VMO was controlled and fabricated using the AG VDO and protrusion bite-registration. These findings confirmed CA fabrication settings impact treatment outcomes. </jats:sec

P076 Sleep Staging Agreement Between Polysomnography and Sleep Profiler in Isolated REM Sleep Behavior Disorder

Abstract Purpose Evaluate the sleep staging agreement between polysomnography (PSG) and Sleep Profiler (SP) in patients with suspected isolated REM-sleep-behavior-disorder. Methods Twenty-six patients with reported dream-enactment-behavior (Site1=16, Site2=10; 27% women; age 64±13 years) underwent a diagnostic PSG with simultaneously recorded SP. A registered sleep-technologist at each site performed PSG-staging, while SP was auto-staged and technically reviewed/edited. Across technicians, the initial staging was blinded. Site1 then performed unblinded restaging of PSG=N3(N2) vs. SP=N2(N3) epochs, while Site2 conducted a blinded, carefully-targeted restaging of N3. Statistics included Cohen’s kappa and Chi-square analyses. Results Agreement between SP and Site1 vs. Site2 were significantly different for Wake (kappa:Site1=0.816;Site2=0.650;combined=0.736), stage N1 (kappa:Site1=0.149;Site2=0.228;combined=0.188), stage N2 (kappa:Site1=0.632;Site2=0.718;combined=0.659), stage N3 (kappa:Site1=0.715;Site2=0.368;combined=0.525) and REM (kappa:Site1=0.827;Site2=0.719;combined=0.766)(all P&amp;lt;0.001). After restaging of N3, the kappa values improved at Site1 (unblinded:N2=0.659/N3=0.883) and Site2 (blinded:N2=0.775/N3=0.736)(combined:N2=0.735/N3=0.851). The proportion of PSG-epochs restaged from N3 to N2 was 17% at Sites1 and 38% at Site2 (P&amp;lt;0.001), while Site1 had fewer remaining PSG=N3 vs. SP=N2 conflicts (5.6% vs. 20.8%, P&amp;lt;0.001). Compared to Site2, Site1 had a superior: REM kappa due to fewer SP=N2 disagreements (8.5% vs. 16.8%, P&amp;lt;0.001), and Wake kappa resulting from fewer SP=N1 (6.6 vs. 15.6%, P&amp;lt;0.001) and SP=N2 conflicts (5.9 vs. 12.0%, P&amp;lt;0.001). Conversely, the Site1 N1 kappa was inferior due to greater SP=wake disagreement (41.6% vs. 19.8%, P&amp;lt;0.001). Discussion N3 was excessively stage by both PSG technicians before restaging. At Site1, Wake, N3, and REM had almost-perfect-agreement with SP, while N2 had substantial-agreement. At Site2 and across-site, substantial-agreement was observed for Wake, N2, N3, and REM. </jats:sec

P077 Reliability of the Clinical Characterization of Isolated REM Sleep Behavior Disorder

Abstract Purpose Compare agreements between polysomnography-based (PSG) diagnosis of isolated REM-sleep-behavior-disorder (iRBD) and Non-REM-Hypertonia (NRH), a novel biomarker independently associated with synucleinopathy-related neurodegenerative diseases. Methods Sixteen patients with histories of dream-enactment-behavior (DEB)(women=38%; age:64.6±13.0) underwent PSG with simultaneously-recorded Sleep Profiler (SP). Two boarded sleep neurologists independently characterized iRBD. Physician1 combined abnormal qualitative REM-sleep-without-atonia (RSWA) by submental electromyography, with video-confirmation of probably DEB. Physician2 relied solely on qualitative RSWA. SP was auto-staged, technically reviewed, and reprocessed for automated abnormal NRH detection. Kappa scores measured physician and NRH agreements. Results In the 14 records with REM sleep, iRBD was characterized in: Physician1=64%, Physician2=79%, NRH=71% of the records. Across the three methods, unanimous iRBD agreement occurred in 57% of the records (positive=7, negative=1). The between-physician agreement in iRBD classifications was fair (kappa=0.32). The agreement between NRH and Physician1 was moderate (kappa=0.52) versus slight with Physician2 (kappa=0.05). NRH comparisons to consensus physician agreement yielded one false-positive and one false-negative iRBD finding. Physician2 classified: a) iRBD in two cases that were negative by Physician1 and NRH, and b) one negative case that Physician1 and NRH characterized as iRBD. Physician1 identified one negative case that was classified iRBD by Physician2 and NRH. Additionally, NRH was abnormal in one of the two records with no REM sleep. Discussion NRH may assist in iRBD risk assessment, given it agreed with at least one physician in 86% of the cases and the between-physician iRBD agreement was only fair. NRH also characterized iRBD-risk in patients with insufficient REM sleep for RSWA assessment. </jats:sec

Effects of deep sedation on sleep in critically ill medical patients on mechanical ventilation.

Atypical EEG patterns not consistent with standard sleep staging criteria have been observed in medical intensive care unit (ICU) patients. Our aim was to examine the relationship between sleep architecture and sedation in critically ill mechanically ventilated patients pre- and post-extubation. We performed a prospective observational repeated measures study where 50 mechanically ventilated patients with 31 paired analyses were examined at an academic medical centre. The sleep efficiency was 58.3 ± 25.4% for intubated patients and 45.6 ± 25.4% for extubated patients (p = .02). Intubated patients spent 76.33 ± 3.34% of time in non-rapid eye movement (NREM) sleep compared to 64.66 ± 4.06% of time for extubated patients (p = .02). REM sleep constituted 1.36 ± 0.67% of total sleep time in intubated patients and 2.06 ± 1.09% in extubated patients (p = .58). Relative sleep atypia was higher in intubated patients compared to extubated patients (3.38 ± 0.87 versus 2.79 ± 0.42; p \u3c .001). Eleven patients were sedated with propofol only, 18 patients with fentanyl only, 11 patients with fentanyl and propofol, and 10 patients had no sedation. The mean sleep times on propofol , fentanyl , propofol and fentanyl, and no sedation were 6.54 ± 0.64, 4.88 ± 0.75, 6.20 ± 0.75 and 4.02 ± 0.62 hr, respectively. The sigma/alpha values for patients on propofol , fentanyl , propofol and fentanyl and no sedation were 0.69 ± 0.04, 0.54 ± 0.01, 0.62 ± 0.02 and 0.57 ± 0.02, respectively. Sedated patients on mechanical ventilation had higher sleep efficiency and more atypia compared to the same patients following extubation. Propofol was associated with higher sleep duration and less disrupted sleep architecture compared to fentanyl, propofol and fentanyl, or no sedation