NCT04153240

The POSA Trial - Positional Therapy for Positional OSA

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Royal Brompton & Harefield NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea, Obstructive
• Positional Sleep Apnea

Interventions

Type	Name	Description
DEVICE	The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA)	The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA) has been developed for adult patients with positional OSA, and snorers. Worn on the back of the neck, it begins to vibrate when the patient starts to sleep in the supine position and increases in intensity until the patient changes.

Timeline

• Start date: 2019-10-30
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2019-11-06
• Last updated: 2023-03-30

Locations

5 sites across 1 country: United Kingdom