Positional Therapy for Obstructive Sleep Apnoea: a Randomised Controlled Trial to Assess the Effect on Health and Wellbeing in Older and Younger People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: 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)
干预措施: The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA) (Device)
结局指标
主要结局
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)
时间窗: 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
次要结局
- 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)