NCT04153240: POSA

The POSA Trial - Positional Therapy for Positional OSA

Completed NA Last updated 30 March 2023

What this trial tests

NA trial testing The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA) in Sleep Apnea, Obstructive in 120 participants. Completed in 1 March 2023.

Timeline

30 October 2019

Primary endpoint
1 March 2023

1 March 2023

Quick facts

Lead sponsor	Royal Brompton & Harefield NHS Foundation Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	30 October 2019
Primary completion	1 March 2023
Estimated completion	1 March 2023
Sites	5 locations across United Kingdom

Drugs / interventions tested

• The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA)

Conditions studied

• Sleep Apnea, Obstructive — all drugs for Sleep Apnea, Obstructive →
• Positional Sleep Apnea — all drugs for Positional Sleep Apnea →

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Who can join

18 and older, any sex, with Sleep Apnea, Obstructive or Positional Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of vibrotactile positional therapy devices on patients with positional obstructive sleep apnoea: a systematic review and meta-analysis.
   ALQarni AS, Turnbull CD, Morrell MJ, Kelly JL. · · 2023 · cited 9× · PMID 37344178 · DOI 10.1136/thorax-2021-218402
2. Vibrotactile positional therapy for the treatment of positional obstructive sleep apnoea: a multicentre, randomised controlled trial.
   Kelly JL, Turnbull CD, Newson R, Dobson M, et al · · 2026 · PMID 40992934 · DOI 10.1136/thorax-2024-222681