The POSA Trial - Positional Therapy for Positional OSA

NCT04153240 | Completed

• 1 other identifier: 252494
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Positional Therapy; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in OSA severity defined by Apnoea-Hypopnoea Index (AHI): Final AHI after 3 months (adjusted for baseline AHI) of patients treated with Positional Therapy, compared to Sham-Positional Therapy(events/hour)

  Apnoea-hypopnea Index (AHI) (events/hour) measured by overnight polygraphy; 0 to \<5 events/hour is no OSA, \>=5 to \<15 events/hour is mild OSA, \>=15to \<30 events/hour is moderate OSA, \>=30 events/hour is severe OSA; Lower AHI is an improvement in disease

  3 months

Secondary Outcomes (12)

• Change in AHI (events/hr) in younger (18-<65yrs) compared to older (>=65years) patients: Final AHI after 3 months (adjusted for baseline AHI) of patients treated with Positional Therapy, compared to Sham-Positional Therapy, in older compared to younger

  3 months

• Changes in Subjective sleepiness: Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in Epworth Sleepiness Scale (ESS)

  3 months

• Changes in Quality of Life - measured by Functional Outcomes of Sleep Questionnaire (FOSQ); Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in FOSQ

  3 months

• Changes in Anxiety and Depression: Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in the Hospital Anxiety and Depression Scale (HADS)

  3 months

• Changes in Independent Functioning: Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in Townsend Disability Scale

  3 months

Other Outcomes (1)

• Effect of age on treatment effect, and on changes in AHI

  3 months

Study Arms (2)

Positional Therapy

EXPERIMENTAL

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

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

Sham Positional Therapy

SHAM COMPARATOR

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

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

Interventions

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

Also known as: Positional Therapy

Positional Therapy; Sham Positional Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• University of Oxford: collaborator

Study Sites (5)

Churchill Hospital

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Aintree Hospital

Liverpool, United Kingdom

Location

The Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

The Freeman Hospital

Newcastle, United Kingdom

Location

Related Publications (1)

• Kelly JL, Turnbull CD, Newson R, Dobson M, Hedley EL, ALQarni AS, Nevinson A, Dawson D, Nickol A, West S, Talbot NP, Rahman NM, Stradling J, Morrell MJ; POSA trial investigators. Vibrotactile positional therapy for the treatment of positional obstructive sleep apnoea: a multicentre, randomised controlled trial. Thorax. 2025 Sep 24:thorax-2024-222681. doi: 10.1136/thorax-2024-222681. Online ahead of print.

  PMID: 40992934 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomised, parallel, double-blinded trial

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: November 6, 2019
• Study Start: October 30, 2019
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)