Short term effects of a vibrotactile neck-based treatment device for positional obstructive sleep apnea: a longitudinal efficacy and tolerability study. Scarlata Simone, MD; Rossi Bartoli Isaura, MD; Santangelo Simona, Giannunzio Gilda, MD; Antonelli Incalzi Raffaele, MD. Chair of Geriatrics, Unit of Respiratory Pathophysiology, Campus Bio Medico University and Teaching Hospital, Rome - Italy Background: Positional obstructive sleep apnea syndrome (POSAS) occurs in approximately 56% of patients with obstructive sleep apnea syndrome (OSAS) [Chest. 1997;112:629–39] and its components characterize a subgroup of both obese and, to a lesser amount, non obese patients suffering from OSAS [Chest. 2005; 128:2130-7]. Quantifying the relevance of position on OSAS is noteworthy since over 70 % of subjects with mild to moderate OSAS are twice as severe supine than non-supine [Eur Arch Otohinolaryngol. 2013; 271(1):189–94]. Avoiding the supine sleeping position, via positional therapy (PT), in whichever form, have a substantial influence on OSAS severity [Eur Respir J. 2011; 37: ]. Several devices designed to limit supine position have been recently developed, but definitive evidence of their efficacy and safety are not conclusive. Few data exist related to a neck-worn vibrating device (Night shift™ Advanced Brain Monitoring, Carlsbad, CA, USA) intended to induce positional change in patients with positional OSA. We therefore evaluated the efficacy of a neck-worn device to induce supine avoidance positional feedback over a short term three days adaptation trial in a population of obstructive sleep apnea patients and its impact on sleep quality and polysomnographyc indexes of disease severity. Materials and Methods : Twenty patients with a high prevalence of positional apneas/hypopneas (86.3% of the total number of apneas; SD 5.8) were prospectively studied. Baseline characteristics of daytime somnolence and risk of sleep apnea were screened by administrating the Epworth Sleepiness Scale and the STOP-BANG questionnaires. The efficacy of a 3 days trial of supine-avoidance therapy by vibrotactile neck worn device was assessed by reporting the self-perceived change in quality of sleep and performing cardio-respiratory polysomnography. Comparison between baseline and treatment results was performed. All patients accepted to participate the study after having received a comprehensive description of the research design and signed an informed consent form. Description of neck-device We tested a positional neck-worn device (Night ShiftTM, Advanced Brain Monitoring, Carlsbad, CA, USA) fastened on the back of the neck with an adjustable rubber strap secured by a magnetic clasp. The device measures snoring with a snore algorithm quantifying each snore based on shape and peak amplitude. The percentage of time snoring is determined by actigraphy. Neck positions are also reported. When used for positional therapy, vibrotactile feedback starts 10-min after the device is turned on, to allow the user to fall asleep. The neck-device can record and provide vibrotactile feedback for three nights in a row before re-charging is needed. Further technical details have been described elsewhere [J Clin Sleep Med. 2014;10: doi: /jcsm.3956]. Sleep evaluation The suspected diagnosis of OSAS was tested through in-hospital cardio-respiratory polysomnography according to current international guidelines [8] by using a 12 channels dedicated device (Somnomedics; GmbH, Randersacker, Germany). Were included those subjects suffering from positional OSAS not deserving, or poorly compliant, to continuous positive airway pressure (CPAP) therapy. The self-perceived change in the quality of sleep after PT was assessed by a questionnaire in which the patients had to score from 1 to 5 his sleep quality as improved (score 4 and 5), unchanged (score 3), or worsened (score 1 and 2). Analytical approach All data are expressed as means (± standard deviations, SD) for continuous variables, or as percentages for categorical variables. The Student’s T test was used to detect differences within the groups. Mann-Whitney test was used to compare the changes in functional values between baseline and during positional therapy. CONCLUSIONS: a comfortable positional device could be considered as a therapeutic option in mild to moderate OSAS and in patients insufficiently treated with CPAP. However, larger studies assessing the effect of this type of treatment on objective sleepiness and cardiovascular comorbidities, as well as defining the impact of vibrotactile stimulation on sleep quality and architecture are needed before positional treatment can be considered as a long term valid and safe first line treatment for patients with OSAS. Correspondence: Results Age (mean; SD)64.8 (9.5) Males (n°; %)15 (75.0) BMI (mean; SD)28.9 (4.0) AHI at baseline (mean, SD)16.8 (9.5) % Prevalence of positional apneas/hypopneas (mean; SD ) 86.3 (5.8) ESS score at baseline (mean; SD)6.8 (4.1) STOP-BANG score at baseline (mean; SD)4.8 (1.3) Baseline PSG values Mean (SD) Positional Therapy PSG values Mean (SD) p-value AHI events/h16.8 (9.5)4.4 (5.5)<0.001 ODI events/h13.7 (7.5)3.8 (5.2)<0.001 RDI events/h20.0 (9.5)5.2 (5.6)<0.001 % time spent supine 62.1 (22.7)33.7 (23.9)<0.001 Impact on the perceived quality of sleep Only 7 out of 20 (28.6%) of patients reported a clear subjective improvement. Five (25%) reported no significant changes and another seven (28.6%) found their sleep quality to be somehow worsened.