Faculty Bibliography

Consumer sleep technologies (CSTs) are widespread applications and devices that purport to measure and even improve sleep. Sleep clinicians may frequently encounter CST in practice and, despite lack of validation against gold standard polysomnography, familiarity with these devices has become a patient expectation. This American Academy of Sleep Medicine position statement details the disadvantages and potential benefits of CSTs and provides guidance when approaching patient-generated health data from CSTs in a clinical setting. Given the lack of validation and United States Food and Drug Administration (FDA) clearance, CSTs cannot be utilized for the diagnosis and/or treatment of sleep disorders at this time. However, CSTs may be utilized to enhance the patient-clinician interaction when presented in the context of an appropriate clinical evaluation. The ubiquitous nature of CSTs may further sleep research and practice. However, future validation, access to raw data and algorithms, and FDA oversight are needed.

Introduction: We evaluate the effectiveness of a single-session Cognitive Behavioral Therapy-Insomnia (CBT-I) program performed in a large group setting, structured to effectively address the high prevalence of disease. Methods: Kaiser Permanente (Fontana) conducts a CBT-I (Sleep Eazzzy) consisting of one 2.5 hour session in groups of 20 taught by a physician assistant. Program addresses: sleep hygiene, sleep beliefs, relaxation techniques, sleep restriction, and sleep position optimization. Individual telephone follow-up is repeated until signiicant improvement or patient declines further follow-up (program completed). Subjective responses from inal telephone follow-up were compared to baseline. Number of healthcare encounters and prescription ills 1 year prior to CBT and 1 year after program completion were compared to objectively assess. Results: 363 patients referred over 12 months completed CBT-I (average 1.3 telephone calls.) 321 (88%) reported improvement (31% reported resolution of insomnia). Statistically signiicant improvement was seen comparing mean pre/post program sleep parameters: sleep latency (57 vs 26 minutes), awakenings (3.0 vs 1.4), total sleep time (5.0 vs 6.5 hours). The 134 patients on sleep medications decreased their use (6.1 vs 4.0 nights/week), and 41 (30%) discontinued sleep medications. Improvements were similar for all groups: men (133), women (233), obstructive sleep apnea (117), use anti-depressants (68), ibromyalgia (30), shiftworkers (20), restless leg syndrome (20). There was decrease in # primary care ofice visits 1 year after program completion compared to 1 year prior to CBT (4.5 vs 3.7; p<0.01). Prescription ills of sleep and antidepressant medications showed no pre/post change; however, pattern of ills reveal crescendo of use prior to CBT and decrescendo after program completion. These differences were not evident in the control group. Conclusion: A single-session CBT program in a large group setting may effectively treat insomnia based on subjective impr!

Introduction: We report real-world experience with nEPAP (PROVENT Sleep Apnea Therapy, Venus Medical, Inc), including assessment of treatment eficacy, predictors of response, and extended adherence to therapy. Methods: OSA patients eligible for a nEPAP trial underwent: clinic orientation, in-home acclimation period, and polysomnography (primarily portable monitoring) to evaluate effectiveness (nEPAP "post-test"). Treatment response was deined as >50% AHI4% improvement and AHI4%<15. Baseline characteristics of Responders and Non-responders were compared. Prescription for nEPAP therapy (an out-of-pocket expense at Kaiser Permanente) was offered to responders. Those accepting nEPAP prescriptions were followed-up by telephone. Results: 214 OSA patients underwent nEPAP orientation; 195 (91%) proceeded with home acclimation; 119 (61%) returned for nEPAP posttest. Among this group, OSA improved (AHI4% 27.5 vs 11.0; p<0.01). 78 (66%) patients met response criteria with a mean nEPAP AHI4% of 4.5 median AHI improvement of 85%. Response rate was similar for mild, moderate, severe OSA. Lower therapeutic CPAP pressures were seen in responders (10 vs 11cmH20; P=0.04). Lower Apnea-Hypopnea Ratio (AHR) on baseline PSG resulted in greater response rate (80% when AHR <0.1; 33% when AHR>5.) 65 of 78 (83%) of responders accepted nEPAP prescriptions. Additional 14 prescriptions were given for patients showing improvement but technically non-responders 7 with positional therapy, and 11 snorers (Total of 97 prescriptions.) 84 (87%) were contacted for follow-up. At time of follow-up (mean 525+336 days after prescription date), 45 (54%) were still using nEPAP with 31 (69%) reporting use at least 4 nights a week. Reasons for discontinuing nEPAP varied (lack of symptomatic improvement, discomfort, cost). Most that discontinued therapy did so within the irst ye.ar Conclusion: We report high rates of eficacy, initial acceptance, and continued adherence with nEPAP therapy. Utility of therapeutic CPAP pressure and AHR as pre!

Introduction: We instituted a respiratory therapist-based CPAP followup program (F/U Pathway) and compared CPAP adherence (3 months and 1 year) to patients without additional structured follow-up (Traditional Pathway) and assessed impact on 1 year healthcare utilization. Methods: Patients undergoing ambulatory polysomnography were randomized to Traditional or F/U Pathway and CPAP was ordered, if indicated, after 1 week autoCPAP titration. Traditional Pathway: CPAP was purchased without structured follow-up. Follow-up Pathway: CPAP rented up to 3 months with monthly compliance checks. At each month, CPAP was converted to purchase without additional follow-up if compliant; if non-compliant, patients underwent troubleshooting with additional month trial. Patients in both pathways were called to return for 3 month and 1 year follow-up. Effect on co-morbidities (blood pressure, HgbA1C) and healthcare utilization were compared at 1 year. Results: 158 were started on CPAP (82 Traditional; 76 Follow-up). F/U Pathway cumulative compliance rates at months 1, 2, and 3 were: 25% (19/76), 62% (47/76), and 70% (53/76). All patients in F/U Pathway versus 54% in Traditional Pathway returned for 3 month follow-up, resulting in compliance (intention-to-treat) of 40.8% versus 20.7% (p=0.006). At 1 year, few patients in either pathway returned (21 F/U Pathway with 33% compliant; 13 Traditional Pathway with 38% compliant). When reviewing DME CPAP utilization (rate of reordering CPAP supplies) as a surrogate for CPAP usage, we estimated F/U Pathway and Traditional Pathway CPAP adherence to be 56% versus 29% (p=0.004). Patients with at least 60% nights with >4 hours usage on 1 week autoCPAP titration was associated with greater 3 month compliance (58% vs 26%; p=0.001) and 1 year adherence (41% vs 28%; p=0.11). There were no signiicant differences in blood pressure, HgbA1C, nor healthcare encounters between CPAP users versus non-users. Conclusion: Respiratory Therapist-based CPAP follow-up program may improve long-ter!

Introduction: Presence of sleep apnea (OSA) may impact postoperative outcomes. We retrospectively assess clinical outcomes and healthcare utilization in patients who underwent total hip and knee arthroplasty (THA and TKA) that were pre-operatively screened for OSA. Methods: Kaiser Permanente (Fontana) identiies patients at high risk for OSA with planned THA and TKA using STOP-BANG questionnaire, and those with score >3 subsequently receive single-channel airlow- based portable monitor (RU Sleeping, Philips) to stratify severity. They are also subsequently referred for formal polysomnography but not necessarily performed prior to surgery. We retrospectively evaluated post-operative complication rates, hospital length of stay (LOS), and post-discharge clinic utilization and utilization of emergency services based on OSA presence and severity. Results: Chart review was performed for 27 patients (17 male, 10 females; age 68.7+8.3; 8 THA, 19 TKA). 8 post-operative complications were seen but only 2 cardiopulmonary related complications (1 cardiac arrest, 1 mental status change requiring Naloxone) both in patients with no OSA. Post-operative hospital LOS showed no statistically signiicant differences in patients with "No OSA" AHI<5 or RU sleeping <10 (n=6, LOS 4+4.1) versus "Mild OSA" AHI 5-19 or RU Sleeping 10-29 (n=4, LOS 2.5+0.6) versus "Severe OSA" AHI >20 or RU Sleeping >30 (n=17, LOS 2.0+0.8). Post-discharge use of emergency services was highest in "Severe OSA" group with 5 ER visits compared to "No OSA" (2 visits) and "Mild OSA" (0 visits), but not statistically signiicant. In the 3 patients on post-operative CPAP use (1 Severe, 2 Mild), none experienced post-operative complications. Conclusion: There was no clear relationship between OSA presence/ severity and rates of post-operative complications nor did OSA signiicantly impact hospital and emergency service utilization. This may be related to insuficient study power, and inclusion of additional patients is pending

Introduction: The effectiveness of oral appliance therapy (OA) for OSA is variable, but ability to predict response based on baseline characteristics is limited. This is a feasibility pilot evaluating the use of a pre-fabricated titratable mandibular advancement device or PFMAD (ApneaRX, Apnea Sciences). If successfully used in a clinical setting, we anticipate evaluating its utility as a possible predictive mechanism. Methods: PFMAD used is a "one size its all" boil-and-bite device with ability to incrementally adjust mandibular position (3mm is neutral position and able to advance to 10mm). Appropriate candidates for OA therapy at Kaiser Permanente Sleep Center (Fontana) were created a PFMAD by a respiratory therapist. Patients were instructed to start at 4mm and advanced nightly by 1mm as tolerated. At maximum tolerable advancement, repeat polysomnography (post-PSG with portable monitor) was performed. We assessed device it, maximum tolerable advancement, eficacy, and acceptance of therapy. Results: 15 patients (7 men, 8 women) were it for PFMAD. 6 returned for post PSG, 4 declined further PFMAD trial (3 preferred CPAP/ Provent, 1 woman unable to wear due to device's large size and was directly referred for custom OA ), and 5 are currently pending follow-up. Of the 6 that returned for post-test PSG, AHI4% improved (17.7+7.8 vs 10.9+7.8; p=0.11) with 2 improving at least 50%. 4 advanced to 6mm, 1 advanced to 8mm (no AHI improvement), and 1 advanced to 5mm (AHI 29.6 improved to 16.4). Overall, 3 wanted OA therapy and were referred for customized OA with further follow-up pending. Conclusion: PFMAD can be feasibly created by non-dental sleep center providers, able to be worn by most patients, and able to be titrated by patients at home (although, optimal titration protocol still requires further investigating). We anticipate studying its utility in predicting eficacy and acceptance of customized OA

Rationale: Oral appliance (OA) therapy is the main alternative to CPAP treatment in patients with obstructive sleep apnea (OSA). There are clear effects from OA when compared to placebo, but a larger variability in outcomes compared to CPAP have been documented. These results are grounded on less than 20 randomized controlled trials. In addition, an important variability regarding study design and methodology has been observed in these studies that have been published over the past 15 years. Therefore a need for more knowledge in larger studies with standardized data to better understand the role and effectiveness of OA in patients with OSA. Objectives: Sixteen academic researchers from nine countries have founded a network focused on OA outcomes. The primary aim of this network called ORANGE (ORal Appliance Network on Global Effectiveness) is to evaluate the long-term effectiveness of OA therapy in OSA patients. Exploratory aims includes: determinate of predictors of treatment outcomes; assess objective compliance and tolerance; evaluate of side-effects; understand the impact of OA on quality of life and mood indices; explore health care costs of this type of therapy in different countries; search indications for combination (at the same time) and alternative (on different days) of oral appliance and CPAP; compare differences between OA types and titration methods; evaluate the incidence of OA contra-indications and assess long-term health outcomes of OA therapy related to cardiovascular disease. Methods: In March 2012, researchers attended the first strategic meeting, funded by the American Academy of Dental Sleep Medicine (AADSM) in Chicago. During the meeting, objectives and feasibility of the registry were discussed. Subcommittees were created to decide on data collection priorities, which were divided into anthropometrics, medical history, sleep test data, questionnaires, dental variables, side-effects, compliance and titration. All participating sites will standardize the data to be collected. Consecutive patients who consent to participate will be included and the data will be entered in a web-based registry called REDCap (Research Electronic Data Capture). The finalized data to be included in the registry were discussed and determined in June 2012, Boston. The network will meet in Paris (AADSM funded) in April 2013, to finalize patient data entry needs, charts and ethical board requirements. Conclusion: ORANGE is a multicentre patient registry with unique research opportunities in the exploration of OA therapy for patients with OSA that plans to start data collection in June 2013