SLEEP APNEA AVOIDANCE PILLOW EFFECTS ON OBSTRUCTIVE SLEEP APNEA SYNDROME AND SNORING

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1 ABSTRACT SLEEP APNEA AVOIDANCE PILLOW EFFECTS ON OBSTRUCTIVE SLEEP APNEA SYNDROME AND SNORING NAJEEB A. ZUBERI, M.D. KAMEL REKAB PhD HAL V. NGUYEN, B.S., RPSGT. The study was performed to determine the ability of a new inclined pillow to treat snoring and obstructive sleep apnea syndrome. The SONA pillow is a triangular pillow with space to place your arm under the head while sleeping on the side. Twenty two patients with NPSG proven OSAS were included in this study, this group included eleven mild, eight moderate and three severe sleep apnea patients. All these patients had a second attended nocturnal polysomnogram performed while utilizing this specific inclined pillow. The pillow was found to be an effective and easily employable treatment for mild ( 5-19) and moderate ( 20-40) obstructive sleep apnea and snoring. In this group ranged from 5.1 to 35.2 and decreased on the average from 17 events per hour to less than 5 events per hour while utilizing the inclined pillow, which is statistically significant with a P- value of Also a statistical significant difference was noted in REM decrement in all patients with mild to moderate sleep apnea with a P-value of.001 and the increase in SAO2 was significant with a P-value of Snoring was found to be affectively decreased or eliminated by this method P-value in all patients. Conclusion: The SONA inclined pillow is an effective treatment for obstructive sleep apnea syndrome in patients with mild to moderate obstructive sleep apnea. Utilizing this pillow stops snoring. Key words: apnea treatment, snoring, pillow, obstructive sleep apnea syndrome 1

2 INTRODUCTION The SONA inclined cervical pillow is designed to treat snoring and obstructive sleep apnea. Position related sleep apnea is a well-known fact but up until now we were not able to overcome the effects of gravity in a manner so as to be able to treat sleep apnea and snoring. Obstructive sleep apnea syndrome is characterized by snoring, pauses in breathing and excessive daytime somnolence. This diagnosis is made by performing a nocturnal polysomnogram in a sleep lab, if respiratory distress index () is > 5/hr then further treatment is warranted. Obstructive sleep apnea syndrome (OSAS) has been shown to have significant morbidity and increased incidence of hypertension, stroke, CHF, MI, cardiac arrhythmias and sleep related accidents and dysthymia. The vast majority of patient s with sleep apnea snore and occasionally also have pauses in their snoring. Detrimental positional effect on obstructive sleep apnea and snoring is well documented. In many patients the is much greater in the supine position compared to the lateral position during sleep (ref #1, 2, 3, 4). In a study performed in outer space (ref #5) Elliot A.R. et al showed that gravity played a dominant role in the generation of apneas, hypopneas and snoring and there was a significant decrease in the microgravity environment in space in all parameters including, snoring and sleep efficiency. Penzel et al (ref #6) performed flow studies during sleep and showed that collapsibility of upper airways is not mediated by sleep stages but is strongly influenced by sleep position and is worse in the supine position. Similarly Oksenberg et al (ref #7) showed that even Cheyne-Stokes respiration which is a central type of breathing abnormality is worse in the supine position. 2

3 Treatment modalities utilizing positional therapy have been attempted, including the ball method to promote sleeping in the lateral recumbent position, may benefit a small percentage of patients with positional dependent snoring and sleep apnea. Mandibular advancing devices avoid retro positioning of the jaw and are effective, but not a well tolerated means of treating obstructive sleep apnea syndrome. Other pillows utilized for ameliorating sleep apnea have used hyperextension of the neck, this was found by Kushida et al (ref #8 and 9) to reduce mild obstructive sleep apnea in patients with mild decrement of and to a lesser degree in moderate sleep apnea but had no effect on snoring and/or sleep efficiency. The SONA pillow is a double incline pillow (per Figure 1), which has about a 45-degree incline on both sides and a flat base. There is an arm positioning recess built on both sides in the base under the incline and also a training arm sling is under the arm positioning recess, which is to be utilized in the initial stages of the acclimatization period with this pillow. The subjects lie in the lateral recumbent position with their head on either inclined sides and have the lower arm extended in the recess under their head. This position is easily acclimatized to and the subjects can turn on either side of the pillow. Supine position is not possible on this pillow as the sides are inclined in a triangular fashion and make sleeping supine impossible, thus promoting persistent lateral positioning with the jaw positioned downward and this counteracts the gravitational effect of supine position. This maintains the oropharynx open by avoiding retro positioning of the jaw and thus treating sleep apnea and snoring. The patients were encouraged to utilize a regular pillow to hug while sleeping on their side, which helps in maintaining this position better. 3

4 METHODS Twenty two subjects were recruited to take part in the study after informed consent and Institutional Review Board approval. These subjects were outpatient clinic patients more than eighteen years of age, with varied medical problems and the selection criterion which was used included a previously abnormal nocturnal polysomnogram showing an of > 5 events per hour and complains of symptoms of OSAS including but not limited to snoring, pauses in breathing excessive daytime somnolence, non refreshing sleep, and bruxism. All studies were performed at the outpatient sleep lab attended and scored by registered polysomnographic technologist and reviewed by Board Certified Neurologist and Sleep Specialist. The only exclusion criteria were patients who could not maintain lateral recumbent position or hold their arm up against their head. Also three subjects were excluded from the study because they could not maintain the lateral position for various reasons. The subjects were established patients of the outpatient facility and had a full neurological examination by the Sleep Specialist prior to the studies. The first night was an attended nocturnal polysomnogram utilizing their regular pillow which they were told to bring from home. These patients slept in the sleep lab in their normal nightly position and were not forced to sleep supine or in any other predetermined position. The second night was performed utilizing the SONA pillow (Figure 1). The time lapse between the first and the second night study was no more than around twelve months. The data was recorded on Nihon Kohden computerized acquisition system utilizing Polysmith acquisition and scoring software. The recorded parameters were nasal-oral airflow, EOG, EMG, EEG, chest wall movement, abdominal movement, heart rate, body position, snoring and O2 saturation. All patients were also digitally video recorded during the studies. All data was manually scored and reviewed. All changes in body position, sleep stages and respiratory events were 4

5 calculated during both nights. All subjects filled out sleep questionnaire prior and after each study. All subjects also had body mass index calculated prior to their study. No prior acclimatization to the SONA pillow was allowed to the patients, so each patient had a novice device with which they were presented at the time of the sleep study. The first group of patients is ones with mild to moderate obstructive sleep apnea (OSAS) with between These are 19 patients in total. Since the sample size is small then there are two appropriate statistical techniques that can be used, the Sign test and the Wilcoxon s signed-rank test. Due to the fact that the amount of skewness for all statistical comparisons were very small, the most powerful nonparametric technique that we used is the Wilcoxon s signed-rank test. In fact, the amount of skewness for the difference between baseline and the Sona pillow (referred as pillow ) is 0.799, which is very small. The amount of skewness for the difference between the baseline REM and the pillow REM is also small, and the amount of skewness for the difference between the lowest baseline SAO2 and the lowest pillow SAO2 is 0.042, which is also very small. The second group of patients is the ones with severe OSAS (>40). There are three patients in total. Since the sample size is very small then a nonparametric technique is used. The amount of skewness for the difference between the baseline and the pillow is 1.732, which is very small. The amount of skewness for the difference between the REM and the pillow REM is and the amount of skewness difference between the lowest baseline SAO2 and the lowest pillow SAO2 is which is also very small. The statistical package that we used in our analysis is SPSS. 5

6 RESULTS A total of twenty two subjects participated in the study. The age range was years and there were 8 men and 14 women in this study. Body mass index was in the range of The baseline in the two groups ranged from 5.1 to 85.8 events per hour. The results are summarized in Table 4 and are discussed further below. There are eleven mild cases with an in the range of events per hour, there are eight moderate obstructive sleep apnea patients with an in the range of and there are three severe sleep apnea patients with an of The baseline study is the diagnostic study with the patient s regular pillow from home and the second night study is the experimental study with the patients sleeping in the lateral position while utilizing the Sona inclined pillow. The analysis was done with grouping of the mild and moderate sleep apnea patients together (group 1) and the severe sleep apnea patients as the second group (group 2). In the first group of the nineteen patients with mild to moderate obstructive sleep apnea syndrome (table 4), the on initial baseline study ranged from 5.1 to 35.2 events per hour. The second night inclined pillow study showed a significant decrease of obstructive sleep apnea syndrome by 68% in these patients, with the obstructive sleep apnea being controlled from an initial baseline overall average of 17 events per hour to an of less than 5 events per hour while utilizing the inclined pillow. Table 1 show that the baseline is very significantly greater than the pillow, in fact the P-value is Similarly in the first group, the ones with mild to moderate sleep apnea the REM was also decreased by 74% from an average at baseline of 41 events per hour (see Table 1) to less than 10 events per hour while utilizing the SONA pillow. The statistical analysis showed that the baseline REM is also very significantly greater than the pillow REM, with P-value of only

7 Overall O2 saturations were also significantly higher during the second night experimental study. As table 1 shows the lowest baseline SAO2 compared to the lowest pillow SAO2 is significantly less, with a P-value of In the second group of patients with severe OSAS there were three patients. The second night study utilizing the inclined pillow showed a significant decrease in and REM by 20% and 76% respectively, see data 2 tables. In severe apnea group as Table 2 shows the baseline is significantly greater than the pillow. In fact the P-value is Also the baseline REM was significantly greater than the pillow REM and the P-value is It also shows that the lowest baseline SAO2 is significantly less than the pillow SAO2 with a P-value of While utilizing the inclined pillow on the second night therapeutic trial snoring was treated in most patients as shown in Table 3 overall. The P-value was very statistically significant being This calculation included all the patients in the study with mild, moderate and severe sleep apnea patients. There was also, as expected a more dramatic affect in non obese patients with a BMI of less than 30, only a single patient with BMI less than thirty continued snoring while utilizing this pillow and he has a history of Bells palsy. Most subjects felt that they slept better and had more consolidated sleep during the second night while utilizing the SONA pillow. The patients with the most amount of benefit were those who could maintain the lateral position on the inclined pillow while keeping their hand extended under their head. 7

8 DISCLOSURE Dr. Kemal Rekab was reimbursed for the support provided for biostatistical analysis and Dr. Zuberi is the inventor of the Sona pillow. DISCUSSION Utilizing the SONA inclined pillow, adequately treats snoring and mild to moderate obstructive sleep apneas of less than 40 events per sleep hour. The patients with severe obstructive sleep apnea with an average of more than 40, could not be considered treated but did show a decrement to a statistically significant degree in their overall and to a significant degree in their REM and all of these patients maintained their oxygen saturation above 90% during the second study. Snoring was decreased and or completely stopped in most patients using the specified pillow. We recognize the limited number of patients in this study, but the dramatic results are encouraging. Further studies would be beneficial comparing the effectiveness of this inclined pillow to CPAP treatment and evaluating compliance and comparative benefits on daily activities. The ideal treatment of sleep apnea is not just attempting to decrease and increase SAO2 alone but attempt is made to find the best method of a more undisturbed sleep, and as during CPAP titration we do not linger on attempting to continuously increase the pressure so as to attempt decreasing the but we strive for a pressure which treats most symptoms without disrupting sleep. Just as in during CPAP titration we do not have a set number which we consider as perfect and occasionally patients still have a above the diagnostic level of 5 events per hour, we will still consider them adequately titrated. The results of this study should be judged in the same manner as CPAP titration and merit consideration as adequate treatment of mild and moderate sleep apnea and snoring. 8

9 As preexisting medical conditions were not used as exclusion criteria, some of the patients had persistent low O2 sats and may be a function of their underlying cardiopulmonary status. Also some of the patients did not maintain the perfect lateral position all through out the inclined pillow night so some desats occurred while they were on their backs and not in the inclined position, and this got reported as part of the second night study. Thus it should be realistically expected to have even better results with adequate acclimatization of the inclined pillow. Another interesting point is the patient s ages, with the average age of fifty eight and oldest patient being seventy three, these patients had multiple premorbid existing conditions. A second phase of this study should be done with direct comparison to CPAP titration in these patients. In conclusion, this inclined pillow works by opening the oropharynx by counteracting the effects of gravity on the mandible and avoiding the retro positioning of the jaw and thus maintaining an open airway. This is an effective treatment for mild and moderate sleep apnea and is beneficial in the treatment of obstructive sleep apnea syndrome and snoring. We propose that this pillow may be utilized by all patients with mild to moderate obstructive sleep apnea syndrome as a part of their treatment as a first line treatment instead of continuous positive airway pressure (CPAP) and mandibular advancing devices and/or other cumbersome surgical procedures. After acclimatization a second night study may be done with this pillow to prove tolerance and effectiveness. 9

10 REFERENCES 1-Cartwright RD. Effect of sleep position on sleep apnea severity, Sleep. 1984;7: Cartwright RD, Lloyd S, Lillie J, et al. Sleep position training as treatment for sleep apnea syndrome: a preliminary study. Sleep. 1985;8: Chaudhary BA, Chaudhary TK, Kolbeck RC, et al. Therapeutic effect of posture in sleep apnea. South Med J. 1986;79: Phillips BA, Okeson J, Paesani D, et al. Effect of sleep position on sleep apnea and Para functional activity. Chest. 1986;90: Elliott AR; Shea SA; Dijk DJ; Wyatt JK; Riel E; Neri DF; Czeisler CA; West JB; Prisk GK, Micro gravity reduces sleep-disordered breathing in humans. Am J Respir Crit Care Med 2001 Aug 1;164(3): Penzel T; Moller M; Becker HF; Knaack L; Peter JH. Effect of sleep position and sleep stage on collapsibility of upper airways in patients with sleep apnea. Sleep 2001 Feb 1;24(1): Oksenberg A; Arons E; Snir D; Radwan H; Soroker N. Cheyne-Stokes respiration during sleep: a possible effect of body position. Med Sci Monit 2002 Jul;8(7):CS Kushida CA; Sherrill CM; Hong SC; Palombini L; Hyde P; Dement WC. Cervical positioning for reduction of sleep disorder breathing in mild to moderate obstructive sleep apnea syndrome. Sleep Breath 2001 Jun;5(2): Clete A. Kushida, Sripad Rao, Christian Guilleminault, Sylvie Giraudo, Janie Hsieh, Pamela Hyde and William C. Dement. Cervical Positional Effects on Snoring and Apneas. Sleep res. Online 2(1):7-10,

11 TABLE 1. COMPARISONS BETWEEN THE SONA PILLOW AND BASELINE FOR, REM AND SAO2, IN PATIENTS WITH MILD TO MODERATE OSAS, GROUP 1 DESCRIPTIVE STATISTICS N MEAN STD. DEVIATION MINIMUM MAXIMUM BASELINE BASELINE REM BASELINE LOWEST SAO % 5.10% 73% 92% PILLOW PILLOW REM PILLOW LOWEST SAO % 3.83% 83% 95% WILCOXON SIGNED RANKS TEST TEST STATISTICS (c) Z ASYMP. SIG. PILLOW - BASELINE PILLOW REM - BASELINE REM LOWEST PILLOW SAO2 - LOWEST BASELINE SAO (a) (a) (b) (2 TAILED) a. BASED ON POSITIVE RANKS b. BASED ON NEGATIVE RANKS c. WILCOXON SIGNED RANKS TEST 11

12 TABLE 2. COMPARISONS BETWEEN PILLOW AND BASELINE FOR, REM, AND SAO2 IN PATIENTS WITH SEVERE OSAS, (GROUP 2) DESCRIPTIVE STATISTICS N MEAN STD. DEVIATION MINIMUM MAXIMUM BASELINE BASELINE REM LOWEST BASELINE SAO % 25.58% 43% 90% PILLOW PILLOW REM LOWEST PILLOW SAO % 1.53% 90% 93% WILCOXON SIGNED RANKS TEST TEST STATISTICS (c) Z PILLOW - BASELINE PILLOW REM - BASELINE REM LOWEST PILLOW SAO2 - LOWEST BASELINE SAO (a) (a) (b) ASYMP. SIG. ( 1 TAILED) a. BASED ON POSITIVE RANKS b. BASED ON NEGATIVE RANKS c. WILCOXON SIGNED RANKS TEST 12

13 TABLE 3. PROPORTION OF DECREASED SNORING FOR ALL SUBJECTS BINOMIAL TEST CATEGORY N OBSERVED PROP. TEST PROPORTION EXACT SIG. (2-TAILED) SNORING DECREASED SNORING UNCHANGED I TOTAL

14 TABLE 4. PILLOW STUDY DATA * AGE SEX BMI BASELINE PILLOW BASELINE REM PILLOW REM LOWEST BASELINE SAO2 LOWEST PILLOW SAO2 SNORING DECREASED PATIENTS WITH MILD TO MODERATE APNEA A 49 F % 85% YES B 45 F % 83% YES C 50 F % 88% YES D 40 F % 87% YES E 60 M % 83% YES F 73 F % 92% YES G 70 F % 88% YES H 71 F % 89% YES I 40 M % 90% NO J 56 F % 87% YES K 69 M % 83% NO L 70 F % 94% YES M 67 M % 89% YES N 44 F % 89% NO O 69 M % 84% YES P 56 F % 85% YES Q 67 M % 85% NO R 69 F % 96% YES S 57 F % 89% YES PATIENTS WITH SEVERE APNEA 60 F % 91% YES 50 F % 90% NO 55 M % 93% YES 14

15 FIGURE 1: SONA PILLOW 15