Clinical trial NCT04153240: The POSA Trial - Positional Therapy for Positional OSA
Official title: Positional Therapy for Obstructive Sleep Apnoea: a Randomised Controlled Trial to Assess the Effect on Health and Wellbeing in Older and Younger People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Positional Sleep Apnea
Keywords: Positional Therapy
Quality of Life
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: University of Oxford
First posted: 2019-11-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomised, parallel, double-blinded trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 3 months
Secondary outcomes:
measure: 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
timeFrame: 3 months
measure: 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)
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: 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)
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: Changes in Quality of Life measured by the Short-form 36 (SF-36); Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in SF-36
timeFrame: 3 months
measure: Changes in subjective sleep quality and bed partner's perspective: Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 months
measure: Changes in Healthcare Utilisation measured by a Healthcare Utilisation Questionnaire
timeFrame: 3 months
measure: Comfort and tolerance of the Positional Therapy device
timeFrame: 3 months
measure: Adherence to Positional Therapy measured by the Night Shift device
timeFrame: 3 months
measure: Changes to Sleeping position measured by the Night Shift device on the first (monitoring night) and last night of Therapy
timeFrame: 3 months
measure: Changes in sleep-disordered breathing measured by overnight polygraphy
timeFrame: 3 months
Other outcomes:
measure: Effect of age on treatment effect, and on changes in AHI
timeFrame: 3 months
Locations:
city: Oxford
country: United Kingdom
facility: Churchill Hospital
state: Oxfordshire
city: Liverpool
country: United Kingdom
facility: Aintree Hospital
city: London
country: United Kingdom
facility: The Royal Free Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Newcastle
country: United Kingdom
facility: The Freeman Hospital
Study officials:
References: