Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in apnea hypopnea index (AHI), percent of baseline.
研究概览
简要总结
The current study combines two treatments for obstructive sleep apnea (OSA), oral appliances and supplemental inspired oxygen. The following aims will be tested:
Aim 1. To determine whether supplemental inspired oxygen further reduces OSA severity (apnea-hypopnea index) in patients using an oral appliance.
Aim 2. To determine whether baseline OSA phenotypes can predict the efficacy of oral appliances versus supplemental oxygen versus both treatments in combination. We will test whether responders to oral appliances have distinct pathophysiological characteristics compared with oxygen responders.
详细描述
Pre-specified primary analysis for Aim 1 is the change in AHI with combination treatment versus oral appliance alone (%reduction versus placebo; including hypopnea events without desaturation/arousals).
Aim 2 seeks to identify subgroups of patients that have the greatest reduction in AHI (responders) with each treatment (post-hoc). We will use baseline physiological measures of the four traits causing OSA (collapsibility, responsiveness, loop gain, arousal threshold) to determine which characteristics predict responses to each intervention (leave-one-out support vector machine modeling). Clinical measures of the same traits will be estimated from the placebo night to confirm that responses can be predicted with clinically-available data. We will also test whether responders to oral appliances have a greater response to oxygen than oral appliance non-responders (and vice-versa), to address whether responders to both treatments are similar or different.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Supplemental oxygen versus air assignment nights will be blinded to participants, but will be known by the investigator. Oral appliances will be "open label".
入排标准
- 年龄范围
- 21 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed OSA or suspected OSA based on snoring
排除标准
- •Severe co-morbidities (cardiovascular, renal, lung disease, neurological), including:
- •Congestive heart failure, Neurological conditions that may affect sleep or breathing (e.g. neuromuscular diseases e.g. myasthenia gravis; neurodegenerative diseases e.g. Alzheimer's/Parkinson's)
- •Medications that will substantially affect respiration, including opioids, barbiturates, theophylline, doxapram, acetazolamide, pseudoephedrine
- •Claustrophobia
- •Insomnia and other non-respiratory sleep disorders
- •Inability to sleep supine
- •Contraindications to oral appliances, including insufficient teeth to support the device, periodontal problems inducing tooth mobility, active temporomandibular joint disorder
- •Allergy to lidocaine or oxymetazoline HCl
研究组 & 干预措施
Combo, Oxygen, Mad, Sham
Order of interventions: Combo, Oxygen, Mad, Sham
干预措施: No treatment (Other)
Combo, Mad, Sham, Oxygen
Order of interventions: Combo, Mad, Sham, Oxygen
干预措施: Oral appliance (Device)
Combo, Mad, Sham, Oxygen
Order of interventions: Combo, Mad, Sham, Oxygen
干预措施: Oxygen (Drug)
Combo, Mad, Sham, Oxygen
Order of interventions: Combo, Mad, Sham, Oxygen
干预措施: Oral appliance plus oxygen (Other)
Combo, Mad, Sham, Oxygen
Order of interventions: Combo, Mad, Sham, Oxygen
干预措施: No treatment (Other)
Combo, Oxygen, Mad, Sham
Order of interventions: Combo, Oxygen, Mad, Sham
干预措施: Oral appliance (Device)
Combo, Oxygen, Mad, Sham
Order of interventions: Combo, Oxygen, Mad, Sham
干预措施: Oxygen (Drug)
Combo, Oxygen, Mad, Sham
Order of interventions: Combo, Oxygen, Mad, Sham
干预措施: Oral appliance plus oxygen (Other)
Combo, Oxygen, Sham, MAD
Order of interventions: Combo, Oxygen, Sham, MAD
干预措施: Oral appliance (Device)
Combo, Oxygen, Sham, MAD
Order of interventions: Combo, Oxygen, Sham, MAD
干预措施: Oxygen (Drug)
Combo, Oxygen, Sham, MAD
Order of interventions: Combo, Oxygen, Sham, MAD
干预措施: Oral appliance plus oxygen (Other)
Combo, Oxygen, Sham, MAD
Order of interventions: Combo, Oxygen, Sham, MAD
干预措施: No treatment (Other)
Combo, Sham, Mad, Oxygen
Order of interventions: Combo, Sham, Mad, Oxygen
干预措施: Oral appliance (Device)
Combo, Sham, Mad, Oxygen
Order of interventions: Combo, Sham, Mad, Oxygen
干预措施: Oxygen (Drug)
Combo, Sham, Mad, Oxygen
Order of interventions: Combo, Sham, Mad, Oxygen
干预措施: Oral appliance plus oxygen (Other)
Combo, Sham, Mad, Oxygen
Order of interventions: Combo, Sham, Mad, Oxygen
干预措施: No treatment (Other)
Combo, Sham, Oxygen, MAD
Order of interventions: Combo, Sham, Oxygen, MAD
干预措施: Oral appliance (Device)
Combo, Sham, Oxygen, MAD
Order of interventions: Combo, Sham, Oxygen, MAD
干预措施: Oxygen (Drug)
Combo, Sham, Oxygen, MAD
Order of interventions: Combo, Sham, Oxygen, MAD
干预措施: Oral appliance plus oxygen (Other)
Combo, Sham, Oxygen, MAD
Order of interventions: Combo, Sham, Oxygen, MAD
干预措施: No treatment (Other)
MAD, Combo, Oxygen, Sham
Order of interventions: MAD, Combo, Oxygen, Sham
干预措施: Oral appliance (Device)
MAD, Combo, Oxygen, Sham
Order of interventions: MAD, Combo, Oxygen, Sham
干预措施: Oxygen (Drug)
MAD, Combo, Oxygen, Sham
Order of interventions: MAD, Combo, Oxygen, Sham
干预措施: Oral appliance plus oxygen (Other)
MAD, Combo, Oxygen, Sham
Order of interventions: MAD, Combo, Oxygen, Sham
干预措施: No treatment (Other)
MAD, Combo, Sham, Oxygen
Order of interventions: MAD, Combo, Sham, Oxygen
干预措施: Oral appliance (Device)
MAD, Combo, Sham, Oxygen
Order of interventions: MAD, Combo, Sham, Oxygen
干预措施: Oxygen (Drug)
MAD, Combo, Sham, Oxygen
Order of interventions: MAD, Combo, Sham, Oxygen
干预措施: Oral appliance plus oxygen (Other)
MAD, Combo, Sham, Oxygen
Order of interventions: MAD, Combo, Sham, Oxygen
干预措施: No treatment (Other)
MAD, Oxygen, Combo, Sham
Order of interventions: MAD, Oxygen, Combo, Sham
干预措施: Oral appliance (Device)
MAD, Oxygen, Combo, Sham
Order of interventions: MAD, Oxygen, Combo, Sham
干预措施: Oxygen (Drug)
MAD, Oxygen, Combo, Sham
Order of interventions: MAD, Oxygen, Combo, Sham
干预措施: Oral appliance plus oxygen (Other)
MAD, Oxygen, Combo, Sham
Order of interventions: MAD, Oxygen, Combo, Sham
干预措施: No treatment (Other)
MAD, Oxygen, Sham, Combo
Order of interventions: MAD, Oxygen, Sham, Combo
干预措施: Oral appliance (Device)
MAD, Oxygen, Sham, Combo
Order of interventions: MAD, Oxygen, Sham, Combo
干预措施: Oxygen (Drug)
MAD, Oxygen, Sham, Combo
Order of interventions: MAD, Oxygen, Sham, Combo
干预措施: Oral appliance plus oxygen (Other)
MAD, Oxygen, Sham, Combo
Order of interventions: MAD, Oxygen, Sham, Combo
干预措施: No treatment (Other)
MAD, Sham, Combo, Oxygen
Order of interventions: MAD, Sham, Combo, Oxygen
干预措施: Oral appliance (Device)
MAD, Sham, Combo, Oxygen
Order of interventions: MAD, Sham, Combo, Oxygen
干预措施: Oxygen (Drug)
MAD, Sham, Combo, Oxygen
Order of interventions: MAD, Sham, Combo, Oxygen
干预措施: Oral appliance plus oxygen (Other)
MAD, Sham, Combo, Oxygen
Order of interventions: MAD, Sham, Combo, Oxygen
干预措施: No treatment (Other)
MAD, Sham, Oxygen, Combo
Order of interventions: MAD, Sham, Oxygen, Combo
干预措施: Oral appliance (Device)
MAD, Sham, Oxygen, Combo
Order of interventions: MAD, Sham, Oxygen, Combo
干预措施: Oxygen (Drug)
MAD, Sham, Oxygen, Combo
Order of interventions: MAD, Sham, Oxygen, Combo
干预措施: Oral appliance plus oxygen (Other)
MAD, Sham, Oxygen, Combo
Order of interventions: MAD, Sham, Oxygen, Combo
干预措施: No treatment (Other)
Oxygen, Combo, Sham, MAD
Order of interventions: Oxygen, Combo, Sham, MAD
干预措施: Oral appliance (Device)
Oxygen, Combo, Sham, MAD
Order of interventions: Oxygen, Combo, Sham, MAD
干预措施: Oxygen (Drug)
Oxygen, Combo, Sham, MAD
Order of interventions: Oxygen, Combo, Sham, MAD
干预措施: Oral appliance plus oxygen (Other)
Oxygen, Combo, Sham, MAD
Order of interventions: Oxygen, Combo, Sham, MAD
干预措施: No treatment (Other)
Oxygen, MAD, Sham, Combo
Order of interventions: Oxygen, MAD, Sham, Combo
干预措施: Oral appliance (Device)
Oxygen, MAD, Sham, Combo
Order of interventions: Oxygen, MAD, Sham, Combo
干预措施: Oxygen (Drug)
Oxygen, MAD, Sham, Combo
Order of interventions: Oxygen, MAD, Sham, Combo
干预措施: Oral appliance plus oxygen (Other)
Oxygen, MAD, Sham, Combo
Order of interventions: Oxygen, MAD, Sham, Combo
干预措施: No treatment (Other)
Oxygen, Sham, Combo, MAD
Order of interventions: Oxygen, Sham, Combo, MAD
干预措施: Oral appliance (Device)
Oxygen, Sham, Combo, MAD
Order of interventions: Oxygen, Sham, Combo, MAD
干预措施: Oxygen (Drug)
Oxygen, Sham, Combo, MAD
Order of interventions: Oxygen, Sham, Combo, MAD
干预措施: Oral appliance plus oxygen (Other)
Oxygen, Sham, Combo, MAD
Order of interventions: Oxygen, Sham, Combo, MAD
干预措施: No treatment (Other)
Oxygen, Sham, MAD, Combo
Order of interventions: Oxygen, Sham, MAD, Combo
干预措施: Oral appliance (Device)
Oxygen, Sham, MAD, Combo
Order of interventions: Oxygen, Sham, MAD, Combo
干预措施: Oxygen (Drug)
Oxygen, Sham, MAD, Combo
Order of interventions: Oxygen, Sham, MAD, Combo
干预措施: Oral appliance plus oxygen (Other)
Oxygen, Sham, MAD, Combo
Order of interventions: Oxygen, Sham, MAD, Combo
干预措施: No treatment (Other)
Sham, Combo, MAD, Oxygen
Order of interventions: Sham, Combo, MAD, Oxygen
干预措施: Oral appliance (Device)
Sham, Combo, MAD, Oxygen
Order of interventions: Sham, Combo, MAD, Oxygen
干预措施: Oxygen (Drug)
Sham, Combo, MAD, Oxygen
Order of interventions: Sham, Combo, MAD, Oxygen
干预措施: Oral appliance plus oxygen (Other)
Sham, Combo, MAD, Oxygen
Order of interventions: Sham, Combo, MAD, Oxygen
干预措施: No treatment (Other)
Sham, MAD, Combo, Oxygen
Order of interventions: Sham, MAD, Combo, Oxygen
干预措施: Oral appliance (Device)
Sham, MAD, Combo, Oxygen
Order of interventions: Sham, MAD, Combo, Oxygen
干预措施: Oxygen (Drug)
Sham, MAD, Combo, Oxygen
Order of interventions: Sham, MAD, Combo, Oxygen
干预措施: Oral appliance plus oxygen (Other)
Sham, MAD, Combo, Oxygen
Order of interventions: Sham, MAD, Combo, Oxygen
干预措施: No treatment (Other)
Sham, MAD, Oxygen, Combo
Order of interventions: Sham, MAD, Oxygen, Combo
干预措施: Oral appliance (Device)
Sham, MAD, Oxygen, Combo
Order of interventions: Sham, MAD, Oxygen, Combo
干预措施: Oxygen (Drug)
Sham, MAD, Oxygen, Combo
Order of interventions: Sham, MAD, Oxygen, Combo
干预措施: Oral appliance plus oxygen (Other)
Sham, MAD, Oxygen, Combo
Order of interventions: Sham, MAD, Oxygen, Combo
干预措施: No treatment (Other)
Sham, Oxygen, Combo, MAD
Order of interventions: Sham, Oxygen, Combo, MAD
干预措施: Oral appliance (Device)
Sham, Oxygen, Combo, MAD
Order of interventions: Sham, Oxygen, Combo, MAD
干预措施: Oxygen (Drug)
Sham, Oxygen, Combo, MAD
Order of interventions: Sham, Oxygen, Combo, MAD
干预措施: Oral appliance plus oxygen (Other)
Sham, Oxygen, Combo, MAD
Order of interventions: Sham, Oxygen, Combo, MAD
干预措施: No treatment (Other)
Sham, Oxygen, MAD, Combo
Order of interventions: Sham, Oxygen, MAD, Combo
干预措施: Oral appliance (Device)
Sham, Oxygen, MAD, Combo
Order of interventions: Sham, Oxygen, MAD, Combo
干预措施: Oxygen (Drug)
Sham, Oxygen, MAD, Combo
Order of interventions: Sham, Oxygen, MAD, Combo
干预措施: Oral appliance plus oxygen (Other)
Sham, Oxygen, MAD, Combo
Order of interventions: Sham, Oxygen, MAD, Combo
干预措施: No treatment (Other)
结局指标
主要结局
Change in apnea hypopnea index (AHI), percent of baseline.
时间窗: Single night
Primary test is difference between combination therapy and oral appliance
次要结局
- Change in frequency of arousals, percent of baseline.(Single night)
- Patient reported sleep quality (visual analog scale)(Single night)
- Morning minus evening systolic blood pressure(Single night)
- Morning minus evening diastolic blood pressure(Single night)
研究者
Scott Aaron Sands
Associate Physiologist / Instructor in Medicine
Brigham and Women's Hospital