The POSA Trial - Positional Therapy for Positional OSA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2023-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep Apnea, Obstructive Positional Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomised, parallel, double-blinded trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Devices are pre-programmed and by the central site by an unblinded researcher. Devices are allocated randomly by an online randomisation schedule. Researchers and participants, and the central Sleep Therapist remain blinded.

Study Groups

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Positional Therapy

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

Sham Positional Therapy

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

Group Type SHAM_COMPARATOR

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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Positional Therapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No