Smart Anti-snore Pillow in the Management of Obstructive Sleep Apnea & Snoring

1. Smart Anti-snore Pillow in the Management of Obstructive Sleep Apnea & Snoring Chang Bing Show-Chwan Memorial Hospital 1. Cheng-Yu Wei*, 2. Ming-Chou Ku, 3. Tsung-Te Chung, 4. Chian-Fang Chung, 4. Ya-Ling Ko 1. Neurology Dep. 2. Orthology Dep. 3. Otolaryngology Dep. 4. Sleep Center

2. Abstract-1 Background: Obstructive sleep apnea (OSA) syndrome is risk factor for hypertension, coronary artery disease and stroke. In Taiwan, many of these individuals who are diagnosed, often refuse surgical treatment or exhibit poor compliance with nightly use of continuous positive airway pressure (CPAP). We assess the role of a special pillow in the treatment of OSA using polysomnography (PSG) data. Methods: Thirty adult patients (15 men, 59.30±12.93 years of age, body mass index 27.35±3.62 kg/m2) of OSA with snoring identified on a baseline PSG were studied. Patients were assigned to a night with Smart Anti-snore Pillow (Hong Jian Technology Co. Ltd., Taichung, Taiwan, Republic of China) under the assessment of secondary PSG.

3. Abstract-2 • Results: The apnea-hypopnea index (AHI) decreased from 21.76±15.69 events per hour to 16.47±17.84 events (p < 0.001). The snore index decreased from 501.50±235.07 events per hour to 360.90±218.10 events (p <0.01). The mean oxygen saturation increased from 90.95±17.31% to 94.15±2.32% (p=0.32). The desaturation index decreased from 15.82±16.34 events per hour to 7.84±2.50 events (p < 0.01). Sleep efficiency and spontaneous arousal index were unchanged before and after therapies. • Conclusion: Smart Anti-snore Pillow therapy has the effects on AHI and snore. It may be a choice of treatment for the patients with OSA and snoring.

4. Introduction-1 Many studies have produced convincing evidence that OSA is associated with an increased risk of cardiovascular morbidity and mortality. OSA may be independently associated with an increased risk for ischemic heart disease, stroke, arrhythmias and mortality. The treatments for adult OSA include positive airway pressure, surgery, oral appliances, weight loss, medications and other conservative treatment. CPAP is the standard form of therapy for treating OSA. Common difficulties associated with CPAP therapy include sense of dryness in the mouth, rhinorrhea, nasal congestion and dryness, mask discomfort, claustrophobia, irritation from device noise, aerophagia, chest discomfort and partner's intolerance. In Taiwan, many patients denied operation or are unable to comply with the use of CPAP. Searching a comfortable method for treating OSA is important subject.

5. Introduction-2 We hypothesize that a Smart Anti-snore Pillow may relieve the symptoms for the patients of OSA with snore. We design a protocol to asses the effect of the special pillow in treating OSA and snore.

6. Treatment for adult OSA Positive airway pressure CPAP Auto-CPAP Bilevel nasal ventilation Surgery Tracheotomy Uvulopalatopharyngoplasty Nasal/sinus surgery Genioglossal advancement/hyoid myotomy Maxillomandibular advancement Oral appliances Weight loss Medications Conservative treatment Positional therapy Treatment of nasal/allergic condition

7. Subjects and Method-1 The protocol of the study was approved by the Show-Chwan Memorial Hospital Research Ethics Review Committee (SCHM_IRB No:991107). All patients provided informed consent before participation.

8. Subjects and Method-2 Patients Thirty OSA patients (15 male, 15 female), aged 59.30±12.93 years who took part in the research were randomly assigned from the Sleep Center in Chang Bing Show-Chwan Memorial Hospital. All patients had an initial baseline PSG study that identified the presence of OSA with snore in three months. The inclusion criteria were as follows: (1) did not receive any management for OSA; (2) age 20 years and (3) provided informed consent. A second PSG study performed during using special pillow therapy for each patient.

9. Subjects and Method-3 Measurement of sleep quality Sleep quality in this study was measured by three sleep questionnaires (translated into Chinese) including Pittsburgh sleep quality index (PSQI), Athens insomnia scale (AIS) and Epworth sleepiness scale (ESS).

10. Subjects and Method-4 Smart Anti-snore Pillow Device The special pillow includes a base and a mobile seat (Hong Jian Technology Co. Ltd., Taichung, Taiwan, Republic of China ) (Figure 1). A shift control assembly shifts the mobile seat between positions and includes a motor, gear set and drive assembly. The head position happens through different positioning of the mobile seat after detecting continuous four snore (Figure 2).

11. Finger 1

12. Finger 2

13. Subjects and Method-5-1 PSG PSG were performed while the patients were breathing room air and consisted of a recording of rib cage and abdominal motion, with air flow measured using a pressure transducer. Snoring was monitored using a snore microphone. The patients wore a position sensor on their chests. Synchronized digital video recordings were also obtained on all patients and reviewed during the scoring process to confirm body position. Other recordings included pulse oximetry, electrocardiogram, electrooculogram, digastric electromyogram, and electroencephalogram. All variables were continuously recorded and stored in a computerized system.

14. Subjects and Method-5-2 Sleep was staged, and arousals were defined using established criteria. Obstructive apneas were defined by the lack of airflow for more than 10 seconds, associated with the presence of ribcage and abdominal movement. Obstructive hypopneas were defined by a 30% decrease in airflow for more than 10 seconds, associated with the presence of ribcage and abdominal movement, and accompanied by an oxygen desaturation of at least 4% or a 50% decrease in airflow associated with a 3% or greater decrease in oxygen saturation or an arousal. Apneas were defined as central if there was a lack of respiratory effort during the period of absent airflow. The AHI was calculated as the number of apneic and hypopneic events per hour of sleep.

15. Subjects and Method-5-3 An arousal was defined as an abrupt shift of electroencephalographic frequency, including alpha, theta, or frequencies greater than 16 Hz (but not spindles) that lasted at least 3 seconds, with at least 10 seconds of stable sleep preceding the change. Other calculated variables included total sleep time, sleep efficiency (total sleep time divided by time in bed), arousal index, desaturation index, AHI, and the percentage of total sleep time with an arterial oxygen saturation (SaO2) of less than 90%. All of the PSG studies were initially scored by a single senior technologist.

16. Subjects and Method-6 Statistical analysis Continuous data were expressed as the mean ± standard deviation; categorical data were expressed as numbers with percentages. Categorical data were compared by using the Fisher's exact test in two independent groups. T or Wilcoxon test for paired samples was used to assess changes in the variables over time within each group. The relationship of mean differences between groups ( AHI and snore index improved or not ) were analyzed with wilcoxon rank sum test. A two tailed p value < 0.05 was considered statistically significant. All data were analyzed using the statistical package SAS for Windows, version 9.2 (SAS Institute Inc., Cary, NC, USA).

17. Results-1 Table 1. Sociodemographic and clinical characteristics of the OSA patients

18. Results-2 Table 2 Comparison of PSG study between baseline and pillow therapy in all patients a: paired_t test

19. Fig. 3. Comparison of PSG parameter between baseline and pillow therapy in all patients

20. Conclusion Our findings have important clinical applications. Smart Anti-snore Pillow therapy has the effects which decrease AHI and snore. It may be a choice of treatment for the patients with OSA and snoring. Future studies will be directed towards understanding the mechanism of Smart Anti-snore Pillow how to effect the respiratory tract in OSA patients.