Efficacy and Safety

2021 ◽  
pp. 123-138
Author(s):  
Vaibhav H. Ramprasad ◽  
Ryan J. Soose
Keyword(s):  
Reconstructive Surgical Procedures ◽  
Upper Airway ◽  
Science Research ◽  
The United States ◽  
Phase Iii ◽  
Apnea Hypopnea Index ◽  
Clinical Criteria ◽  
Obstructive Sleep ◽  
Patient Reported ◽  
Event Rates

Electrical stimulation of the hypoglossal nerve through implantable neuromodulation systems (UAS) has been demonstrated to be both safe and effective in the management of obstructive sleep apnea (OSA) in a subset of patients meeting specific clinical criteria. After decades of animal and human basic science research confirmed the feasibility and safety of UAS, multiple prospective studies, including the phase III multicenter Stimulation Therapy for Apnea Reduction (STAR) trial, demonstrated the efficacy of UAS in improving both polysomnographic (apnea–hypopnea index, oxygen desaturation index) and patient-reported (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, Snoring Visual Analog Scale) outcome measures. Even with the widespread dissemination into routine clinical practice and commercial availability of the therapy across the United States and Europe, these studies also consistently report very low procedure-related or therapy-related serious adverse event rates. Recent comparison studies with upper airway reconstructive surgical procedures suggest that UAS provides treatment that is at least as effective but with reduced postoperative pain and risk, and with preservation of the upper airway anatomy.

scholarly journals 0676 Long-term Effects Of Upper Airway Stimulation For Treatment Of Obstructive Sleep Apnea On Measurements Of Central And Mixed Apneas

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A258-A258
Author(s):  
S A Myers ◽  
K M Sundar ◽  
P J Strollo
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Upper Airway ◽  
Phase Iii ◽  
Apnea Hypopnea Index ◽  
Medical Systems ◽  
Long Term Effects ◽  
Upper Airway Stimulation ◽  
Obstructive Sleep

Abstract Introduction Upper airway stimulation (UAS) of the hypoglossal nerve for obstructive sleep apnea (OSA) is well-tolerated and results in sustained reduction in the apnea-hypopnea index (AHI). Treatment-emergent CSA is reported to occur in 3.5-19.8% of OSA patients treated with CPAP. We aimed to examine the occurrence or emergence of central and mixed apneas in a cohort of participants that received UAS and were followed for 5 years post implantation. Methods The Stimulation Trial for Apnea Reduction (STAR) was a Phase III trial evaluating the safety and efficacy of UAS for CPAP-intolerant OSA. Major inclusion criteria were CPAP intolerance, AHI between 20-50, less than 25% central and mixed apneas and BMI <= 32. Polysomnography was performed at baseline, 12, 18, 36 and 60-month follow-up. Data were scored by a core lab and was then retrospectively analyzed via the STAR PSG database to measure the evolution of central and mixed apneas on UAS therapy. Results Baseline age was 54.5 ± 10.2 years, BMI was 28.4 ± 2.6 kg/m2 and 83% male (n=126). AHI data were non-normally distributed. Median AHI was 29.3/hr at baseline, that was reduced to 9/hr at 12-months and 6/hr at 60-months. Median central apnea index (CAI) was 0.8/hr at baseline, 0.4/hr at 12-months, and 0.2/hr at 60-months. Median mixed apnea index (MAI) was 0.2/hr at baseline, 0.7/hr at 12-months and 0.4/hr at 60-months. The 12- and 60-month CAI was significantly lower than baseline (p<0.05), but MAI was not. The percentage of central and mixed events remained stable throughout follow-up, approximately at 5% of the total AHI. Conclusion UAS reduced the overall AHI and results in a small but significant decrease in CAI. Given that OSA and CSA frequently co-exist, the role of UAS on reducing CSA in patients with combined OSA and CSA deserves further investigation. Support STAR study was sponsored by Inspire Medical Systems

Aerodynamics Analysis of the Impact of Nasal Surgery on Patients with Obstructive Sleep Apnea and Nasal Obstruction

ORL ◽  
2021 ◽  
pp. 1-8
Author(s):  
Lifeng Li ◽  
Demin Han ◽  
Hongrui Zang ◽  
Nyall R. London
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Nasal Obstruction ◽  
Upper Airway ◽  
Apnea Hypopnea Index ◽  
Nasal Surgery ◽  
Subjective Sleep Quality ◽  
Obstructive Sleep ◽  
Significant Difference ◽  
The Impact

<b><i>Objective:</i></b> The purpose of this study was to evaluate the effects of nasal surgery on airflow characteristics in patients with obstructive sleep apnea (OSA) by comparing the alterations of airflow characteristics within the nasal and palatopharyngeal cavities. <b><i>Methods:</i></b> Thirty patients with OSA and nasal obstruction who underwent nasal surgery were enrolled. A pre- and postoperative 3-dimensional model was constructed, and alterations of airflow characteristics were assessed using the method of computational fluid dynamics. The other subjective and objective clinical indices were also assessed. <b><i>Results:</i></b> By comparison with the preoperative value, all postoperative subjective symptoms statistically improved (<i>p</i> &#x3c; 0.05), while the Apnea-Hypopnea Index (AHI) changed little (<i>p</i> = 0.492); the postoperative airflow velocity and pressure in both nasal and palatopharyngeal cavities, nasal and palatopharyngeal pressure differences, and total upper airway resistance statistically decreased (all <i>p</i> &#x3c; 0.01). A significant difference was derived for correlation between the alteration of simulation metrics with subjective improvements (<i>p</i> &#x3c; 0.05), except with the AHI (<i>p</i> &#x3e; 0.05). <b><i>Conclusion:</i></b> Nasal surgery can decrease the total resistance of the upper airway and increase the nasal airflow volume and subjective sleep quality in patients with OSA and nasal obstruction. The altered airflow characteristics might contribute to the postoperative reduction of pharyngeal collapse in a subset of OSA patients.

818 A Ghost from the Past: Unmasked Insomnia Affecting Hypoglossal Nerve Stimulation Therapy Adherence

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A319-A320
Author(s):  
Elena Stuewe ◽  
Aarti Grover ◽  
Peter Ostrow ◽  
Greg Schumaker ◽  
Joel Oster ◽  
...  
Keyword(s):  
Nerve Stimulation ◽  
Hypoglossal Nerve ◽  
Sleep Onset ◽  
Chronic Insomnia ◽  
Apnea Hypopnea Index ◽  
Therapy Adherence ◽  
Hypoglossal Nerve Stimulation ◽  
Obstructive Sleep ◽  
Patient Reported ◽  
History Of

Abstract Introduction Hypoglossal nerve stimulation (HNS) is an efficacious option for treating moderate to severe obstructive sleep apnea (OSA). However, there is sparse evidence regarding tolerance and adherence to HNS therapy in patients with a diagnosis of insomnia. Report of case(s) A 57-year-old man with well-controlled depression presented for evaluation for HNS therapy. He had been diagnosed with moderate OSA with an apnea-hypopnea index of 22/hour, intolerant of continuous positive airway pressure and mandibular advancement device. He underwent uvulopalatopharyngoplasty without significant improvement. At the time of initial evaluation, he denied history of insomnia and prior sleep aid use. He subsequently underwent successful HNS device implantation and activation. One week after HNS initiation, the patient reported new symptoms of significant difficulty with sleep onset and inability to fall back asleep, which was worse than his untreated OSA symptoms. Device interrogation did not reveal any hardware problems. Adjustments to start delay, pause time and device configuration with awake endoscopy did not improve tolerance. Subsequently, the patient disclosed a remote history of insomnia, which was treated with multiple hypnotics in addition to cognitive-behavioral therapy for insomnia (CBTi) and had resolved. He was diagnosed with recurrent chronic insomnia, for which eszopiclone was initiated without significant improvement. He eventually agreed to CBTi, with partial improvement in device tolerance and improvement in insomnia symptoms. Conclusion This case highlights that HNS therapy adherence can be affected by prior history of, or a current diagnosis of insomnia. Our patient had a predisposition for insomnia that was well controlled prior to HNS therapy initiation. The onset of recurrent insomnia with HNS activation suggests that HNS was a precipitating factor for his now chronic insomnia. Although there is insufficient evidence to suggest whether history of insomnia should affect the decision to initiate HNS therapy, this case illustrates the importance of screening for insomnia at pre-implant evaluation. Our center is now routinely screening for a history of insomnia to identify patients who may benefit from treatment prior to HNS implantation. Larger studies are needed to explore a possible relationship between insomnia and HNS adherence. Support (if any):

Predicting critical closing pressure in children with obstructive sleep apnea using fluid structure interaction simulations

2021 ◽  
Author(s):  
Goutham Mylavarapu ◽  
Ephraim Gutmark ◽  
Sally Shott ◽  
Robert J. Fleck ◽  
Mohamed Mahmoud ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Upper Airway ◽  
Dynamic Mri ◽  
Patient Specific ◽  
Apnea Hypopnea Index ◽  
Structure Interaction ◽  
Obstructive Sleep ◽  
Mri Scans ◽  
Closing Pressure

Surgical treatment of obstructive sleep apnea (OSA) in children requires knowledge of upper airway dynamics, including the closing pressure (Pcrit), a measure of airway collapsibility. We applied a Flow-Structure Interaction (FSI) computational model to estimate Pcrit in patient-specific upper airway models obtained from magnetic resonance imaging (MRI) scans. We sought to examine the agreement between measured and estimated Pcrit from FSI models in children with Down syndrome. We hypothesized that the estimated Pcrit would accurately reflect measured Pcrit during sleep and therefore reflect the severity of OSA as measured by the obstructive apnea hypopnea index (AHI). All participants (n=41) underwent polysomnography and sedated sleep MRI scans. We used Bland Altman Plots to examine the agreement between measured and estimated Pcrit. We determined associations between estimated Pcrit and OSA severity, as measured by AHI, using regression models. The agreement between passive and estimated Pcrit showed a fixed bias of -1.31 (CI=-2.78, 0.15) and a non-significant proportional bias. A weaker agreement with active Pcrit was observed. A model including AHI, gender, an interaction term for AHI and gender and neck circumference explained the largest variation (R2 = 0.61) in the relationship between AHI and estimated Pcrit. (P <0.0001). Overlap between the areas of the airway with lowest stiffness, and areas of collapse on dynamic MRI, was 77.4%±30% for the nasopharyngeal region and 78.6%±33% for the retroglossal region. The agreement between measured and estimated Pcrit and the significant association with AHI supports the validity of Pcrit estimates from the FSI model.

433 Insomnia and Restless Legs Syndrome in Patients with Upper Airway Stimulation Therapy

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A171-A172
Author(s):  
Mohammed Jomha ◽  
Shalini Manchanda ◽  
Stephanie Stahl ◽  
Noah Parker
Keyword(s):  
Restless Legs Syndrome ◽  
Statistical Significance ◽  
Upper Airway ◽  
Post Treatment ◽  
Apnea Hypopnea Index ◽  
Upper Airway Stimulation ◽  
Therapy Adherence ◽  
Restless Legs ◽  
Obstructive Sleep ◽  
Pre Treatment

Abstract Introduction Insomnia and restless legs syndrome (RLS) are common sleep disorders that may impact obstructive sleep apnea (OSA) treatment. To our knowledge, no studies have investigated whether these comorbidities affect upper airway stimulation (UAS) therapy adherence and outcomes. This study aims to explore possible effects of insomnia and RLS in patients using UAS therapy. Methods All patients who underwent UAS system implantation for treatment of OSA at our facility were retrospectively studied. Pre- and post-implant histories and data, including diagnostic sleep testing, otolaryngology evaluation, activation results, and treatment evaluation, were analyzed. Patients with no insomnia or RLS were compared to patients with insomnia, RLS, or both. Apnea-hypopnea index (AHI), Epworth Sleepiness Scale (ESS), and adherence were compared pre- and post-treatment for each group. Results Sixty-four patients who have undergone UAS implantation at our center have completed post-treatment in-lab titration and evaluation of their UAS system. Insomnia was present in 47%, RLS in 28%, and both insomnia and RLS in 14%. In all groups, the overall AHI during in-lab titration was &gt;50% lower than the pre-treatment AHI (16.1+/-14.3/h vs 32.5+/-13.1/h, p&lt;0.001). While the trend in AHI reductions suggested a lower AHI in those without insomnia or RLS, the reduction did not reach statistical significance (no insomnia or RLS 15.7+/-12.9/h, insomnia 16.9+/-16.7/h, RLS 19.0+/-15.5/h, both insomnia and RLS 23.4+/-18.4/h). UAS therapy usage was reduced in patients with RLS (3.9+/-2.6 h/night, p=0.029) and in patients with both insomnia and RLS (3.9+/-1.3 h/night, p=0.046) compared to patients with neither comorbidity (5.9+/-1.9 h/night). Mean reduction in ESS was similar across groups, averaging from 11+/-5 pre-treatment to 7+/-5 post-treatment (p&lt;0.001). Conclusion Insomnia and RLS are common in patients using UAS therapy for OSA. Pre- and post-treatment residual AHI and ESS significantly improved in all patient groups assessed. A decrease in UAS usage was present in patients with RLS and both RLS and insomnia. Our study suggests that identification and treatment of RLS and insomnia may play an important role for UAS therapy adherence and efficacy, thus, optimizing care. Support (if any):

857 Too sleepy: A pediatric case of Prader Willi Syndrome and Narcolepsy

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A333-A333
Author(s):  
Elizabeth Lam ◽  
Sonal Malhotra ◽  
Daniel Glaze
Keyword(s):  
Daytime Sleepiness ◽  
Sleep Latency ◽  
Chromosome Region ◽  
Genetic Disorder ◽  
Sleep Onset ◽  
Apnea Hypopnea Index ◽  
Prader Willi Syndrome ◽  
Obstructive Sleep ◽  
Patient Reported

Abstract Introduction Prader Willi syndrome (PWS) is a genetic disorder due to deletion of the paternal copies of genes within the chromosome region 15q11-q13. Individuals with PWS are commonly seen with obesity, sleep disordered breathing, and excessive daytime sleepiness (EDS). While the exact cause of EDS in individuals with PWS is not fully understood, there have been reports of PWS with narcolepsy-like syndrome. We report a case of a patient with PWS with findings suggesting the diagnosis of Narcolepsy Type 2. Report of case(s) Our patient is a 12-year-old male with PWS and 2nd degree heart block who was evaluated in our pediatric sleep center. He has a previous diagnosis of mild obstructive sleep apnea (OSA) with an apnea hypopnea index (oAHI) of 3.2. At 12 years of age, mother and patient reported that he had increased snoring, weight gain, EDS with a Pediatric Daytime Sleepiness Score (PDSS) of 10 and frequent refreshing naps during the daytime. Patient denied cataplexy during that visit. Subsequently, 2-week actigrapghy was performed which demonstrated an average total night sleep of 8 hours and 8 minutes. Overnight PSG with Multiple Sleep Latency Test (MSLT) demonstrated an oAHI of 4.8, total sleep time of 6.88 hours. During the MSLT, the mean sleep latency was 6.2 minutes and 5 sleep onset REM periods were observed over 5 nap opportunities. At his follow-up visit, methylphenidate was initiated after clearance by his cardiologist. Patient and mother opted for medical management of his mild OSA with Fluticisone and Montelukast. At his follow-up appointment, the patient had improvement in daytime sleepiness with a PDSS of 2 despite taking his Methylphenidate at night. Patient was instructed to switch to morning Methylphenidate dosing to optimize treatment of his EDS. Conclusion EDS is a common complaint seen in patients with PWS, however the etiology of it is not entirely understood. It is thought to be centrally mediated with components of hypersomnia and narcolepsy like-symptoms. More research is needed to better understand, diagnose and adequately treat patients with PWS and EDS. Support (if any):

Upper Airway Effective Compliance during Wakefulness and Sleep in Obese Adolescents Studied via 2-Dimensional Dynamic MRI and Semi-automated Image Segmentation

2021 ◽  
Author(s):  
Kok Ren Choy ◽  
Sanghun Sin ◽  
Yubing Tong ◽  
Jayaram K. Udupa ◽  
Dirk M. Luchtenburg ◽  
...  
Keyword(s):  
Upper Airway ◽  
Dynamic Mri ◽  
Cross Sectional Area ◽  
Apnea Hypopnea Index ◽  
Morphological Operations ◽  
Sectional Area ◽  
Cross Sectional ◽  
Automated Method ◽  
Obstructive Sleep ◽  
Effective Compliance

Novel biomarkers of upper airway biomechanics may improve diagnosis of Obstructive Sleep Apnea Syndrome (OSAS). Upper airway effective compliance (EC), the slope of cross-sectional area versus pressure estimated using computational fluid dynamics (CFD), correlates with apnea-hypopnea index (AHI) and critical closing pressure (Pcrit). The study objectives are to develop a fast, simplified method for estimating EC using dynamic MRI and physiological measurements, and to explore the hypothesis that OSAS severity correlates with mechanical compliance during wakefulness and sleep. Five obese children with OSAS and five obese control subjects age 12-17 underwent anterior rhinomanometry, polysomnography and dynamic MRI with synchronized airflow measurement during wakefulness and sleep. Airway cross-section in retropalatal and retroglossal section images was segmented using a novel semi-automated method that uses optimized singular-value decomposition (SVD) image filtering and k-means clustering combined with morphological operations. Pressure was estimated using rhinomanometry Rohrer coefficients and flow rate, and EC calculated from the area-pressure slope during five normal breaths. Correlations between apnea-hypopnea index (AHI), EC, and cross-sectional area (CSA) change were calculated using Spearman rank correlation. The semi-automated method efficiently segmented the airway with average Dice Coefficient above 89% compared to expert manual segmentation. AHI correlated positively with EC at the retroglossal site during sleep (rs=0.74, p=0.014), and with change of EC from wake to sleep at the retroglossal site (rs=0.77, p=0.01). CSA change alone did not correlate significantly with AHI. EC, a mechanical biomarker which includes both CSA change and pressure variation, is a potential diagnostic biomarker for studying and managing OSAS.

851 Self-Medication with Caffeine for 31 Years: A Case of Undiagnosed Childhood Narcolepsy Type II

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A331-A331
Author(s):  
Moustapha Doulaye Seydou ◽  
Christian Karime ◽  
Brenda Wyrick ◽  
Amir Khan
Keyword(s):  
Sleep Latency ◽  
Treatment Plan ◽  
Sleep Onset ◽  
Panic Attacks ◽  
Apnea Hypopnea Index ◽  
Type Ii ◽  
Obstructive Sleep ◽  
Sleep Benefit ◽  
Patient Reported ◽  
Multiple Episodes

Abstract Introduction Narcolepsy represents a relatively rare chronic neurological sleep disorder. While peak incidence occurs in adolescence and early-adulthood, reports indicate a substantial number of children under 10 remain undiagnosed or are misdiagnosed. The present case describes a female with undiagnosed narcolepsy type II self-medicating with caffeinated beverages from the age of 7. Report of case(s) A 40-year-old female presented at our clinic with excessive daytime fatigue and hypersomnolence despite adequate sleep (Epworth sleepiness scale= 16/24). The patient denied snoring, sleep paralysis, catalepsy, and hypnagogic/hypnopompic hallucinations. Symptoms began at the age of 7 and steadily worsened, with teachers reporting significant concentration difficulties and multiple episodes of unintentional sleep onset in the classroom. The patient reported heavily relying on caffeinated beverages from the age of 7 to remain awake and focused on classroom activities. Starting at the age of 7, the patient consumed on average a caffeine-equivalent of 1 espresso shot/day (64mg caffeine/day). This increased to 4–6 espresso shots/day (256-384mg caffeine/day) by the age of 12 and 5–9 espresso shots/day (320-576mg caffeine/day) by the age of 18. At the age of 25, the patient developed severe anxiety with panic attacks and episodes of suicidal ideation. With multiple episodes of sleep onset while operating a motor vehicle, a near-accident prompted medical evaluation. Diagnosed with general anxiety disorder and idiopathic hypersomnolence, escitalopram and armodafinil were started with limited effect. The patient continued self-medicating with caffeinated beverages until age 38 when she was diagnosed with narcolepsy type II. Sodium oxybate was subsequently added to her treatment plan with initial sleep benefit and caffeine reduction. A repeat mean sleep latency test confirmed narcolepsy type II (mean sleep latency= 3 minutes, mean rapid eye movement [REM] sleep latency= 3 minutes). Polysomnography was later performed due to non-resolving symptoms, revealing mild obstructive sleep apnea (REM apnea-hypopnea index= 13.5/hour). Continuous positive airway pressure was added to the treatment regime with significant sleep benefit. Conclusion We describe a case of undiagnosed childhood narcolepsy type II necessitating significant caffeine consumptions in order to maintain classroom performance. With known anxiety-provoking effects of caffeine, the case highlights the importance of addressing childhood narcolepsy. Support (if any):

scholarly journals An assessment of a simple clinical technique to estimate pharyngeal collapsibility in people with obstructive sleep apnea

SLEEP ◽  
2020 ◽  
Vol 43 (10) ◽  
Author(s):  
Amal M Osman ◽  
Benjamin K Tong ◽  
Shane A Landry ◽  
Bradley A Edwards ◽  
Simon A Joosten ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Characteristic Curve ◽  
Upper Airway ◽  
Clinical Intervention ◽  
Apnea Hypopnea Index ◽  
Cpap Titration ◽  
Obstructive Sleep ◽  
Airway Collapsibility ◽  
Upper Airway Collapsibility

Abstract Study Objectives Quantification of upper airway collapsibility in obstructive sleep apnea (OSA) could help inform targeted therapy decisions. However, current techniques are clinically impractical. The primary aim of this study was to assess if a simple, novel technique could be implemented as part of a continuous positive airway pressure (CPAP) titration study to assess pharyngeal collapsibility. Methods A total of 35 participants (15 female) with OSA (mean ± SD apnea–hypopnea index = 35 ± 19 events/h) were studied. Participants first completed a simple clinical intervention during a routine CPAP titration, where CPAP was transiently turned off from the therapeutic pressure for ≤5 breaths/efforts on ≥5 occasions during stable non-rapid eye movement (non-REM) sleep for quantitative assessment of airflow responses (%peak inspiratory flow [PIF] from preceding 5 breaths). Participants then underwent an overnight physiology study to determine the pharyngeal critical closing pressure (Pcrit) and repeat transient drops to zero CPAP to assess airflow response reproducibility. Results Mean PIF of breaths 3–5 during zero CPAP on the simple clinical intervention versus the physiology night were similar (34 ± 29% vs. 28 ± 30% on therapeutic CPAP, p = 0.2; range 0%–90% vs. 0%–95%). Pcrit was −1.0 ± 2.5 cmH2O (range −6 to 5 cmH2O). Mean PIF during zero CPAP on the simple clinical intervention and the physiology night correlated with Pcrit (r = −0.7 and −0.9, respectively, p &lt; 0.0001). Receiver operating characteristic curve analysis indicated significant diagnostic utility for the simple intervention to predict Pcrit &lt; −2 and &lt; 0 cmH2O (AUC = 0.81 and 0.92), respectively. Conclusions A simple CPAP intervention can successfully discriminate between patients with and without mild to moderately collapsible pharyngeal airways. This scalable approach may help select individuals most likely to respond to non-CPAP therapies.

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