Thorax · 2026
Vibrotactile positional therapy for the treatment of positional obstructive sleep apnoea: a multicentre, randomised controlled trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Kelly Julia L, Turnbull Chris D, Newson Roger, Dobson Melissa, Hedley Emma L, ALQarni Abdullah S, Nevinson Ann, Dawson David, Nickol Annabel, West Sophie, Talbot Nick P, Rahman Najib M, Stradling John, Morrell Mary J, POSA trial investigators
Аннотация
BACKGROUND: New generation positional therapy devices provide vibrotactile feedback to patients with positional obstructive sleep apnoea (POSA), reducing supine sleep time and sleep apnoea severity. Longer-term effects on POSA severity, sleepiness and quality of life (QoL) are unclear.
METHODS: A randomised, parallel, double-blinded trial compared neck-worn positional therapy with sham-positional therapy over 3 months (ClinicalTrials.gov: NCT04153240).Adult patients with POSA (apnoea/hypopnoea index (AHI) >5 events/hour, 2:1 when supine vs non-supine) were randomised (1:1).The primary endpoint was AHI at 3 months, positional versus sham. Secondary analyses: interaction between the treatment effect and age; QoL, including Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI).
RESULTS: Between October 2019 and August 2022, 120 patients with median baseline AHI of 12.8 events/hour (IQR 9.2-18.5) were randomised; 59 to positional therapy and 61 to sham; 92 (77%) completed the trial. Positional therapy significantly reduced the AHI by -4.41 events/hour (95% CI -7.77 to -1.06; p=0.011) compared with sham, a 34% improvement. There was a significant improvement in PSQI: -1.0 (95% CI -2.1 to 0.0; p=0.04), but not ESS: -0.6 (95% CI -1.8 to 0.6; p=0.3), with positional therapy compared with sham (baseline ESS 8.8). Similar results were seen in younger (18-64) and older (≥65) age groups. Patients' bed partners reported improvements in snoring and sleep quality for the patient and themselves. Over half of participants using the active device opted to continue.
CONCLUSION: Neck-worn positional therapy reduced the severity of OSA and improved sleep quality but not sleepiness, over 3 months. Bed partner's reported improvements in snoring and sleep quality.
TRIAL REGISTRATION NUMBER: NCT04153240.
METHODS: A randomised, parallel, double-blinded trial compared neck-worn positional therapy with sham-positional therapy over 3 months (ClinicalTrials.gov: NCT04153240).Adult patients with POSA (apnoea/hypopnoea index (AHI) >5 events/hour, 2:1 when supine vs non-supine) were randomised (1:1).The primary endpoint was AHI at 3 months, positional versus sham. Secondary analyses: interaction between the treatment effect and age; QoL, including Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI).
RESULTS: Between October 2019 and August 2022, 120 patients with median baseline AHI of 12.8 events/hour (IQR 9.2-18.5) were randomised; 59 to positional therapy and 61 to sham; 92 (77%) completed the trial. Positional therapy significantly reduced the AHI by -4.41 events/hour (95% CI -7.77 to -1.06; p=0.011) compared with sham, a 34% improvement. There was a significant improvement in PSQI: -1.0 (95% CI -2.1 to 0.0; p=0.04), but not ESS: -0.6 (95% CI -1.8 to 0.6; p=0.3), with positional therapy compared with sham (baseline ESS 8.8). Similar results were seen in younger (18-64) and older (≥65) age groups. Patients' bed partners reported improvements in snoring and sleep quality for the patient and themselves. Over half of participants using the active device opted to continue.
CONCLUSION: Neck-worn positional therapy reduced the severity of OSA and improved sleep quality but not sleepiness, over 3 months. Bed partner's reported improvements in snoring and sleep quality.
TRIAL REGISTRATION NUMBER: NCT04153240.