New forehead device in positional obstructive sleep apnoea: a randomised clinical trial.

RATIONALE: Approximately 60% of the patients with obstructive sleep apnoea suffer from a positional effect, and approximately 25% of these patients present events only in the supine position. OBJECTIVE: To validate a new positional vibrating device and evaluate its efficacy in reducing the Apnoea-Hypopnoea Index and the total sleep time in the supine position without disturbing sleep. METHODS: A total of 128 patients were recruited for this multicentre, prospective, parallel, randomised controlled trial and were distributed in three arms (general recommendations, inactive and active device). Full overnight polysomnography was performed at baseline and at 12 weeks. Anthropometric variables and sleep and quality of life questionnaires were collected at 4, 8 and 12 weeks. RESULTS: The Apnoea-Hypopnoea Index decreased from 30.6 per hour to 20.4 per hour (p<0.001) in the active device (AD) group. In this group the reduction was 2.3-fold and 3.3-fold than the ones in the general recommendations (GR) and inactive device (ID) groups, respectively (p=0.014). Sleep time in supine position decreased 17.7%±26.3% in GR group (p<0.001), 13.0%±22.4% with ID group (p<0.001) and 21.0%±25.6% in the AD group (p<0.001). Furthermore, total sleep time increased significantly only in the AD group (22.1±57.5 min, p=0.016), with an increased percentage of time in the N3 (deep sleep) and N3+REM (rapid eye movement) stages, without sleep fragmentation. CONCLUSION: The device was effective in reducing the Apnoea-Hypopnoea Index and time spent in the supine position also in improving sleep architecture. Therefore, the device could be a good option for the management of patients with positional obstructive sleep apnoea. TRIAL REGISTRATION DETAILS: The trial was registered at www.clinicaltrials.gov (NCT03336515).

Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial.

BACKGROUND: The influence of body position in obstructive sleep apnoea patients is well known. A positional therapy device placed at the forehead has proven to be effective in reducing the severity of positional obstructive sleep apnoea (POSA) symptoms. The aim of the study was to evaluate patients' therapy compliance and satisfaction in the short term and mid-term. METHODS: A post hoc analysis of a randomised controlled trial was conducted using an inactive device (ID) or an active device (AD) for 3 months. The primary outcomes were device usage and the percentage of patients with good compliance (defined as device use for more than 4 hours per night and more than 70% of nights per week). Secondary outcomes included time spent with head in the supine position, patient satisfaction and side effects. RESULTS: The median duration of using the device was 6.9 hours in the ID group and 6.7 hours in the AD group (p=0.309), and the durations were similar throughout the follow-up period and from the first day of use. The percentage of patients with good compliance was similar and greater than 60% in both groups. The median time spent with head in the supine position was significantly lower in the AD group (2.9%) than in the ID group (12.4%) since the first day of treatment. Both groups showed satisfaction scores values above 8.5 (out of 10) in all items, while side effects were scarcely reported. CONCLUSION: High device compliance was achieved in POSA patients, both in terms of device usage time and percentage of days used. Patients were highly satisfied, and the device effectively reduced the time spent with the head in the supine position from the first day of use.

A new postural device for the treatment of positional obstructive sleep apnea. A pilot study.

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: Twelve patients had complete data. The device reduced time spent in the supine position (from 51.5 ±â€¯14.8% to 25.2 ±â€¯21.0%, p = 0.005), median AHI (from 30.7 (23.2-38.2) at baseline to 21.5 (12.4-24.3) at the fourth week, p = 0.002). Also an improvement in the minimum SaO2 (from 82.2 ±â€¯7.5 to 87.2 ±â€¯3.6 at the 4th week) was also observed. No variations in sleep quality or quantity were identified. All patients evaluated the device positively. 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.

Correction to: Updated clinical guidelines experience major reporting limitations.

After publication of the original article [1] it was brought to our attention that author Laura Hidalgo Armas was incorrectly included as Laura Hildago Armas.

Updated clinical guidelines experience major reporting limitations.

BACKGROUND: The Checklist for the Reporting of Updated Guidelines (CheckUp) was recently developed. However, so far, no systematic assessment of the reporting of updated clinical guidelines (CGs) exists. We aimed to examine (1) the completeness of reporting the updating process in CGs and (2) the inter-observer reliability of CheckUp. METHODS: We conducted a systematic assessment of the reporting of the updating process in a sample of updated CGs using CheckUp. We performed a systematic search to identify updated CGs published in 2015, developed by a professional society, reporting a systematic review of the evidence, and containing at least one recommendation. Three reviewers independently assessed the CGs with CheckUp (16 items). We calculated the median score per item, per domain, and overall, converting scores to a 10-point scale. Multiple linear regression analyses were used to identify differences according to country, type of organisation, scope, and health topic of updated CGs. We calculated the intraclass coefficient (ICC) and 95% confidence interval (95% CI) for domains and overall score. RESULTS: We included in total 60 updated CGs. The median domain score on a 10-point scale for presentation was 5.8 (range 1.7 to 10), for editorial independence 8.3 (range 3.3 to 10), and for methodology 5.7 (range 0 to 10). The median overall score on a 10-point scale was 6.3 (range 3.1 to 10). Presentation and justification items at recommendation level (respectively reported by 27 and 38% of the CGs) and the methods used for the external review and implementing changes in practice were particularly poorly reported (both reported by 38% of the CGs). CGs developed by a European or international institution obtained a statistically significant higher overall score compared to North American or Asian institutions (p = 0.014). Finally, the agreement among the reviewers on the overall score was excellent (ICC 0.88, 95% CI 0.75 to 0.95). CONCLUSIONS: The reporting of updated CGs varies considerably with significant room for improvement. We recommend using CheckUp to assess the updating process in updated CGs and as a blueprint to inform methods and reporting strategies in updating.