Positional Therapy for Obstructive Sleep Apnoea: a Randomised Controlled Trial to Assess the Effect on Health and Wellbeing in Older and Younger People
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 5
- Primary Endpoint
- 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)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
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)
Intervention: The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA) (Device)
Sham Positional Therapy
The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA) - set in 'MONITOR' mode (ie. no vibration feedback will be given)
Intervention: The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA) (Device)
Outcomes
Primary Outcomes
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)
Time Frame: 3 months
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
Secondary Outcomes
- Changes to Sleeping position measured by the Night Shift device on the first (monitoring night) and last night of Therapy(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 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)
- Comfort and tolerance of the Positional Therapy device(3 months)
- Adherence to Positional Therapy measured by the Night Shift device(3 months)
- Changes in sleep-disordered breathing measured by overnight polygraphy(3 months)
- 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 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 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)(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 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(3 months)
- Changes in Healthcare Utilisation measured by a Healthcare Utilisation Questionnaire(3 months)