TABLE VIII.D. 1.
Study | Year | LOE | Study design | Study groups | Clinical endpoint | Conclusion | |||
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Eijsvogel et al.1396 | 2015 | 2b | RCT | 55 patients with positional OSA (defined as supine AHI ≥ 2 times nonsupine AHI and non-supine AHI < 10) with chest worn device (n = 29, SPT, NightBalance) vs. tennis ball technique (n = 26) | AHI, compliance (use ≥4 h/day and ≥5 days/week) | Equal reduction AHI (SPT: 11.4 vs. 3.9, TBT: 13.1 vs. 5.8), better compliance in SPT arm (SPT: 75.9% vs. TBT: 42.3%, p = 0.01). | |||
Laub et al.1397 | 2017 | 1b | RCT | 101 patients with positional OSA (defined as supine AHI ≥2 times nonsupine AHI, supine AHI > 10 and non-supine AHI < 10) with chest worn device (n = 52, SPT, NightBalance) vs. no treatment (n = 49) | AHI, % supine sleep, sleepiness, compliance (SPT use >4 h/night all week) | At 2 months, AHI improved in the SPT group (from 18.1 to 10.4 on per-protocol analysis, p = 0.008) and remained unchanged in the control group (p = 0.2). Percentage of time supine improved in both groups and ESS did not change in either group. Compliance with SPT was 75.5%. | |||
Benoist et al.1392 | 2017 | 2b | RCT | 99 patients with positional OSA (defined as supine AHI ≥ 2 times nonsupine AHI) with chest worn device (n = 48, SPT, NightBalance) vs. oral appliance therapy (n = 51) | AHI, compliance | SPT and oral appliance equally effective. At 3 months, AHI decreased in both groups (SPT: 13.9–8.7, oral appliance: 13.2–8.1, p < 0.001 for both). Only SPT decreased percentage of time in supine sleep (42.4–14.2, p < 0.001). | |||
de Ruiter et al.1395 | 2017 | 1a | RCT | 58 patients with positional OSA (defined as supine AHI ≥ 2 times nonsupine AHI) with chest worn device (n = 29, SPT, NightBalance) vs. oral appliance therapy (n = 29) | AHI, compliance | SPT and oral appliance equally effective. At 12 months, AHI decreased in both groups (SPT: 13.2–7.1, oral appliance: 13.4–5.0, p < 0.001 for both). Only SPT decreased percentage of time in supine sleep (41.6–12.7, p < 0.001). | |||
Berry et al.1393 | 2019 | 1b | Non-inferiority RCT, cross over | 117 patients with positional OSA (defined as AHI ≥15 or AHI 10–15 with ESS > 10 and supine AHI ≥ 2 times nonsupine AHI) with CPAP vs. chest worn device (SPT, NightBalance) followed by crossover | Adherence, AHI, PROMs | SPT non-inferior to CPAP with improved AHI in both groups (SPT: 21.5–7.3, CPAP: 21.5–3.7). SPT had greater nightly adherence than CPAP (345.3 vs. 286.98 min, p < 0.0001). | |||
Mok et al.1403 | 2020 | 2b | Non-inferiority RCT, crossover | 40 patients with ESS 10–16, positional OSA (defined as supine AHI ≥ 2 times nonsupine AHI, supine AHI > 10 and non-supine AHI < 10) with CPAP vs. neck worn device (Night Shift) | AHI, ESS | With regard to decrease in AHI, PT inferior to CPAP (PT: 23.4–13.0, CPAP: 23.4–4.0, p < 0.001). With regard improvement in ESS, PT noninferior to CPAP. |
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Srijithesh et al.1405 | 2019 | SR, Cochrane | 323 patients with OSA treated with positional therapy vs. CPAP (n = 72) or positional therapy vs. inactive control (n = 251) | AHI, ESS | Positional therapy was less effective than CPAP for reducing AHI (6.4 fewer events per hour with CPAP, 95% CI 3.00–9.79; low-certainty evidence) but compliance may be higher. Positional therapy was more effective than inactive control in reducing AHI and ESS. | ||||
van Maanen et al.1401 | 2013 | 2b | Single arm | 36 patients with positional OSA (defined as supine AHI > 2 times nonsupine AHI) with chest worn device (Sleep Position Trainer [SPT]NightBalance) | AHI, sleep efficiency, ESS, FOSQ, compliance | At 1 month, the median percentage of supine sleeping time decreased from 49.9% to 0.0% (p < 0.001) and median AHI decreased from 16.4 to 5.2 (p < 0.001). | |||
van Maanen et al.1402 | 2012 | 2b | Single arm | 36 patients with positional OSA (defined as supine AHI > 2 times nonsupine AHI) with simple neck worn device | AHI, sleep quality | Mean AHI decreased from 27.7 to 12.8 (p < 0.01) and mean percentage of supine sleeping time decreased from 40% to 19% with use of the device. | |||
van Maanen et al.1400 | 2014 | 2b | Single arm | A total of patients with positional OSA (defined as supine AHI > 2 times nonsupine AHI) and data from chest worn device (SPT, NightBalance) | Sleep efficiency, ESS, FOSQ, compliance | Long-term reduction of percentage of supine sleep from 21% to 3% (p < 0.001) at 6 months and improvement of ESS and QOL. | |||
Levendowsky et al.1398 | 2014 | 1b | Single arm | 30 patients with positional OSA (defined as supine AHI ≥ 1.5 times nonsupine AHI) with neck worn device (NightShift) | AHI, SO2, depression score, sleep architecture | Improvement of mean AHI from 24.7 to 7.5 (p < 0.00001), decrease in percentage of time O2 sat <90% (from 4.2 to 1.2, p < 0.01), and improved sleep architecture. | |||
Beyers et al.1394 | 2019 | 1b | Single arm | 58 patients with positional OSA (defined as supine AHI ≥ 2 times nonsupine AHI) with chest worn device (SPT, NightBalance) | Long-term AHI, % supine sleep, sleep quality, compliance | At 1 year, 85% of patients were still using the device and 75% reported subjective improvement in sleep quality. Mean AHI improved from 16.4 to 6.2 (p < 0.001), percentage of time in supine sleep was reduced from 37.1% to 1.4% (p < 0.001). | |||
Dieltjens et al.1404 | 2015 | 1b | RCT | 20 patients with residual positional OSA after mandibular advancement device use (defined as supine AHI ≥ 2 times nonsupine AHI, supine AHI>10 and non-supine AHI<10) with chest worn device (SPT, NightBalance) vs. combination of chest worn device and mandibular advancement device | AHI, compliance | SPT and MAD equally effective at reducing AHI and ODI, combination more effective with decrease in AHI from 20.9 to 5.5, p < 0.008). |