We are proud to announce the publication of our Somnibel pilot study in the Respiratory Medicine journal. You can access the complete publication online: https://www.resmedjournal.com/article/S0954-6111(19)30041-1/abstract
A new postural device for the treatment of positional obstructive sleep apnea. A pilot study
Laura Hidalgo Armasa,1, Cecilia Turinob,1, José Cordero-Guevarac, Jose Luis Manjónd,e, Joaquín Durán-Carrod,e, Ferrán Barbéb,f, Rafaela Vacab, Joaquín Durán-Cantollac,d,e,f,g,∗, on behalf of the Spanish Sleep Network (Jorge Ullatei,j, Juan Carrilloi,j, Manuel Sanchez-de-la-Torreh,k, Sandra Inglési,j, Carlos Egeai,k,l)
a Unidad de Ensayos Clínicos, Instituto de Investigación Bioaraba, OSI Araba Hospital Universitario, Vitoria, Spain
b Translational Research in Respiratory Medicine, IRBlleida, Lleida, Spain
c Unidad de Metodología y Estadística, Instituto de Investigación Bioaraba, OSI Araba Hospital Universitario, Vitoria, Spain
d Unidad de Trastornos del Sueño, Hospital OSI Araba Hospital Universitario, Vitoria, Spain
e Servicio de Investigación, Instituto de Investigación Bioaraba, OSI Araba Hospital Universitario, Vitoria, Spain
f CIBER de Enfermedades Respiratorias (CibeRes), ISCIII, Madrid, Spain
g Facultad de Medicina, Departamento de Medicina, Universidad del País Vasco, UPV/EHU, País Vasco, Spain
h Translational Research in Respiratory Medicine, IRBlleida, Lleida, Spain
i Unidad de Trastornos del Sueño, Hospital OSI Araba Hospital Universitario, Vitoria, Spain
j Servicio de Investigación, Instituto de Investigación Bioaraba, OSI Araba Hospital Universitario, Vitoria, Spain
k CIBER de Enfermedades Respiratorias (CibeRes), ISCIII, Madrid, Spain
l Facultad de Medicina, Departamento de Medicina, Universidad del País Vasco, UPV/EHU, País Vasco, Spain
Background: Approximately 60% of obstructive sleep apnea (OSA) diagnoses are position-dependent, and avoidance of the supine position could represent an effective treatment. Nevertheless, the majority of the available anti-supine treatments result in discomfort and low adherence. This study evaluated the effectiveness of a new vibrating supine avoidance device in reducing time spent in the supine position and the apnea-hypopnea index (AHI) without affecting sleep structure. Furthermore, the tolerability and satisfaction were also scored.
Methods: Observational prospective study of patients suffering from positional OSA. They were treated with a vibrating device and followed up at the first and fourth weeks after starting the treatment, and further polysomnographic studies were conducted while patients’ wore the device. The comparison of the results was carried out through non-parametric tests. Significance level was 5%.
Results: The main baseline PSG characteristics of the 12 patients with complete data are shown in Table 1. The mean age was 46.5 ± 9.5 years (75% men), and the mean BMI was 25.7 ± 3.3 kg/m2. The mean systolic and diastolic blood pressure was 124. 7 ± 9.4 mmHg and 78.0 ± 5.8 mmHg, respectively, and four patients were diagnosed with systemic hypertension. Four patients were smokers, and two were habitual alcohol consumers. The mean ESS value was 6.7 ± 3.7. No differences in clinical characteristics after 4 weeks of follow-up were registered. The percentage of TST spent in the supine position was significantly reduced from 51.5 ± 14.8% at baseline to 16.4 ± 16.0% at the first week (p=0.002) to 25.2 ± 21.0% at the fourth week, (p=0.005). (Fig. 2).
Accordingly, a significant reduction in the median AHI was registered during the study, from 30.7 (23.2–38.2)/h at baseline, to 21.0 (13.7–28.7)/h at the first week (p=0.004) to 21.5 (12.4–24.3)/h four weeks (p=0.002) after starting treatment (Fig. 3). Additionally, AHI in the supine position was collected, from 42.1 (36.1–55.0)/h at baseline, to 4.5 (0.13–20.2)/h at the 1st week (p=0.002) to 13.0 (0.25–17.2)/h at the 4th week (p=0.003) (Fig. 4).
Overall, 9.2 points of absolute reduction in the median AHI value (baseline vs 4 weeks) was registered (Fig. 3), reaching a 29.1 point reduction in the AIH in supine position (Fig. 4), and a relative reduction of 69.1%. A global reduction of the AHI was observed in all patients, with a global reduction of 30% at the fourth week. Similarly, an improvement in the minimum SaO2 (from 82.7 ± 7.5 to 88.1 ± 3.7 and 87.2 ± 3.6) and in the percentage of time spent with SaO2 < 90% (from 7.6 (0–23.7) to 0.50 (0–1.8) and 0.95 (0.03–7.8)) were achieved after one and four weeks of treatment, respectively (Table 1). No variations in sleep quality or quantity or increased sleep fragmentation were observed while using the device; conversely, a reduction in the arousal index was registered (Table 1). A visual-analogue scale (Appendix A) ranging from 0 to 10 (0=the worst evaluation, 10=the best evaluation) was used to score the tolerability of the positional device and patient satisfaction (Fig. 5). The results were quite homogeneous, with little variability across patients, and all the items received scores greater than 7.3 ± 1.8, with 10 being the best score.
Conclusion: Our device was effective in reducing the time spent in the supine position and improving AHI, SaO2 variables and sleep architecture. The device was well tolerated by the patients.
To our knowledge, this is the first device designed to be positioned on the patient’s forehead. In addition, this innovative body position could increase comfort, leaving patients’ thorax, back and neck free from unpleasant devices that limit their movements. Additionally, the device’s absence of cables or belts, very light weight (14 gr) and small size make it comfortable, easy to use, and easy to transport. Also, the ease of assembly and wear and the automatic activation of the device could improve patients’ motivation to use it. All of these characteristics could contribute to ensuring effectiveness without discouraging device use, as already suggested by the patients’ good tolerability of the device. In conclusion, this study suggests that this new elaborated device shows the effectiveness of positional therapy in reducing OSA and the supine position without disturbing patients’ quality of sleep. Moreover, the device has good compliance and is comfortable for use among patients with positional OSA. This type of device could be very useful for patients with positional OSA. Further studies should confirm that the device on the forehead is as effective as a device on the chest or neck.