The POSA Trial - Positional Therapy for Positional OSA — POSA  

Sleep Apnea, Obstructive Clinical Trial

Official title: Positional Therapy for Obstructive Sleep Apnoea: a Randomised Controlled Trial to Assess the Effect on Health and Wellbeing in Older and Younger People

Status Completed

Clinical Trial Summary

Vibro-tactile feedback may be beneficial for some patients, who have positional obstructive sleep apnoea (OSA).

Aim: to determine whether Positional Therapy, applied by a discrete neck-worn vibro-tactile feedback device, is an effective treatment for positional OSA, in reducing the disease severity and associated symptoms, compared to Sham-Positional Therapy. The interaction between treatment and age will also be assessed, since pathophysiology, symptoms and treatment tolerance varies with age.

Methods: A prospective randomised, parallel, double-blinded trial comparing Positional Therapy (Night Shift™; Advanced Brain Monitoring, USA) with Sham-Positional Therapy, performed in older (>65 years) and younger patients with positional OSA (apnoea/hypopnea index (AHI)>5 events/hour, 2:1 when supine). The primary endpoint, AHI at 3 months, will be measured by a repeat study with the device in situ, and compared between Positional Therapy and Sham-Positional Therapy. Patients' subjective symptoms, wellbeing and quality of life, will be assessed by questionnaires at baseline and 3 months. Adherence to therapy will be measured.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Apnea
• Positional Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

• NCT number: NCT04153240
• Study type: Interventional
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Completion date: March 1, 2023