The POSA Trial - Positional Therapy for Positional OSA

Royal Brompton & Harefield NHS Foundation Trust

Status: Completed

Conditions: Sleep Apnea, Obstructive; Positional Sleep Apnea

Treatments: Device: The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04153240

252494

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged ≥18
• Ability and willingness to provide informed consent
• AHI >5 events/hour (AASM 2012 scoring criteria) with events occurring at a frequency of 2:1 when supine, compared to non-supine; total % supine sleep >20, <90% of total sleep; central apnoeas <20% total apnoeas; recording of ≥4 hours of analysable signals
• Ability to fit and tolerate wearing the device around the neck during treatment demonstration and initiation

Exclusion criteria

• Unstable cardiac disease
• Cardiac arrhythmia corrected with an artificial pacemaker
• Supplemental oxygen
• Secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, Obesity Hypoventilation Syndrome; or shift workers
• Concerns about sleepy driving or any other potentially dangerous symptom from physician
• BMI ≥40 Kilogram/m2
• Inability to sleep in a non-supine position
• Skin sensitivity or an open wound around neck
• Neck circumference <12inches (30cm) or > 22inches (55cm)
• Tics or tremors of the head
• Sleep with head in upright position
• A female of child-bearing potential that is pregnant or intends to become pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Positional Therapy

Experimental group

Description:

The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA) - set in 'THERAPY' mode (ie. vibration feedback will be given in response to supine position)

Treatment:

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

Sham Positional Therapy

Sham Comparator group

Description:

The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA) - set in 'MONITOR' mode (ie. no vibration feedback will be given)

Treatment:

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