Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Registration Number
- NCT03189173
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- Diagnosed OSA or suspected OSA based on snoring
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Combo, Mad, Sham, Oxygen Oral appliance Order of interventions: Combo, Mad, Sham, Oxygen Combo, Mad, Sham, Oxygen Oxygen Order of interventions: Combo, Mad, Sham, Oxygen Oxygen, Combo, Sham, MAD Oral appliance plus oxygen Order of interventions: Oxygen, Combo, Sham, MAD Oxygen, Combo, Sham, MAD No treatment Order of interventions: Oxygen, Combo, Sham, MAD Combo, Mad, Sham, Oxygen Oral appliance plus oxygen Order of interventions: Combo, Mad, Sham, Oxygen Combo, Mad, Sham, Oxygen No treatment Order of interventions: Combo, Mad, Sham, Oxygen Combo, Oxygen, Mad, Sham Oral appliance Order of interventions: Combo, Oxygen, Mad, Sham Combo, Oxygen, Mad, Sham Oxygen Order of interventions: Combo, Oxygen, Mad, Sham Combo, Oxygen, Mad, Sham Oral appliance plus oxygen Order of interventions: Combo, Oxygen, Mad, Sham Combo, Oxygen, Mad, Sham No treatment Order of interventions: Combo, Oxygen, Mad, Sham Combo, Oxygen, Sham, MAD Oral appliance Order of interventions: Combo, Oxygen, Sham, MAD Combo, Oxygen, Sham, MAD Oxygen Order of interventions: Combo, Oxygen, Sham, MAD Combo, Oxygen, Sham, MAD Oral appliance plus oxygen Order of interventions: Combo, Oxygen, Sham, MAD Combo, Oxygen, Sham, MAD No treatment Order of interventions: Combo, Oxygen, Sham, MAD Combo, Sham, Mad, Oxygen Oral appliance Order of interventions: Combo, Sham, Mad, Oxygen Combo, Sham, Mad, Oxygen Oxygen Order of interventions: Combo, Sham, Mad, Oxygen Combo, Sham, Mad, Oxygen Oral appliance plus oxygen Order of interventions: Combo, Sham, Mad, Oxygen Combo, Sham, Mad, Oxygen No treatment Order of interventions: Combo, Sham, Mad, Oxygen Combo, Sham, Oxygen, MAD Oral appliance Order of interventions: Combo, Sham, Oxygen, MAD Combo, Sham, Oxygen, MAD Oxygen Order of interventions: Combo, Sham, Oxygen, MAD Combo, Sham, Oxygen, MAD Oral appliance plus oxygen Order of interventions: Combo, Sham, Oxygen, MAD Combo, Sham, Oxygen, MAD No treatment Order of interventions: Combo, Sham, Oxygen, MAD MAD, Combo, Oxygen, Sham Oral appliance Order of interventions: MAD, Combo, Oxygen, Sham MAD, Combo, Oxygen, Sham Oxygen Order of interventions: MAD, Combo, Oxygen, Sham MAD, Combo, Oxygen, Sham Oral appliance plus oxygen Order of interventions: MAD, Combo, Oxygen, Sham MAD, Combo, Oxygen, Sham No treatment Order of interventions: MAD, Combo, Oxygen, Sham MAD, Combo, Sham, Oxygen Oral appliance Order of interventions: MAD, Combo, Sham, Oxygen MAD, Combo, Sham, Oxygen Oxygen Order of interventions: MAD, Combo, Sham, Oxygen MAD, Combo, Sham, Oxygen Oral appliance plus oxygen Order of interventions: MAD, Combo, Sham, Oxygen MAD, Combo, Sham, Oxygen No treatment Order of interventions: MAD, Combo, Sham, Oxygen MAD, Oxygen, Combo, Sham Oral appliance Order of interventions: MAD, Oxygen, Combo, Sham MAD, Oxygen, Combo, Sham Oxygen Order of interventions: MAD, Oxygen, Combo, Sham MAD, Oxygen, Combo, Sham Oral appliance plus oxygen Order of interventions: MAD, Oxygen, Combo, Sham MAD, Oxygen, Combo, Sham No treatment Order of interventions: MAD, Oxygen, Combo, Sham MAD, Oxygen, Sham, Combo Oral appliance Order of interventions: MAD, Oxygen, Sham, Combo MAD, Oxygen, Sham, Combo Oxygen Order of interventions: MAD, Oxygen, Sham, Combo MAD, Oxygen, Sham, Combo Oral appliance plus oxygen Order of interventions: MAD, Oxygen, Sham, Combo MAD, Oxygen, Sham, Combo No treatment Order of interventions: MAD, Oxygen, Sham, Combo MAD, Sham, Combo, Oxygen Oral appliance Order of interventions: MAD, Sham, Combo, Oxygen MAD, Sham, Combo, Oxygen Oxygen Order of interventions: MAD, Sham, Combo, Oxygen MAD, Sham, Combo, Oxygen Oral appliance plus oxygen Order of interventions: MAD, Sham, Combo, Oxygen MAD, Sham, Combo, Oxygen No treatment Order of interventions: MAD, Sham, Combo, Oxygen MAD, Sham, Oxygen, Combo Oral appliance Order of interventions: MAD, Sham, Oxygen, Combo MAD, Sham, Oxygen, Combo Oxygen Order of interventions: MAD, Sham, Oxygen, Combo MAD, Sham, Oxygen, Combo Oral appliance plus oxygen Order of interventions: MAD, Sham, Oxygen, Combo MAD, Sham, Oxygen, Combo No treatment Order of interventions: MAD, Sham, Oxygen, Combo Oxygen, Combo, Sham, MAD Oral appliance Order of interventions: Oxygen, Combo, Sham, MAD Oxygen, Combo, Sham, MAD Oxygen Order of interventions: Oxygen, Combo, Sham, MAD Oxygen, MAD, Sham, Combo Oral appliance Order of interventions: Oxygen, MAD, Sham, Combo Oxygen, MAD, Sham, Combo Oxygen Order of interventions: Oxygen, MAD, Sham, Combo Oxygen, MAD, Sham, Combo Oral appliance plus oxygen Order of interventions: Oxygen, MAD, Sham, Combo Oxygen, MAD, Sham, Combo No treatment Order of interventions: Oxygen, MAD, Sham, Combo Oxygen, Sham, Combo, MAD Oral appliance Order of interventions: Oxygen, Sham, Combo, MAD Oxygen, Sham, Combo, MAD Oxygen Order of interventions: Oxygen, Sham, Combo, MAD Oxygen, Sham, Combo, MAD Oral appliance plus oxygen Order of interventions: Oxygen, Sham, Combo, MAD Oxygen, Sham, Combo, MAD No treatment Order of interventions: Oxygen, Sham, Combo, MAD Oxygen, Sham, MAD, Combo Oral appliance Order of interventions: Oxygen, Sham, MAD, Combo Oxygen, Sham, MAD, Combo Oxygen Order of interventions: Oxygen, Sham, MAD, Combo Oxygen, Sham, MAD, Combo Oral appliance plus oxygen Order of interventions: Oxygen, Sham, MAD, Combo Oxygen, Sham, MAD, Combo No treatment Order of interventions: Oxygen, Sham, MAD, Combo Sham, Combo, MAD, Oxygen Oral appliance Order of interventions: Sham, Combo, MAD, Oxygen Sham, Combo, MAD, Oxygen Oxygen Order of interventions: Sham, Combo, MAD, Oxygen Sham, Combo, MAD, Oxygen Oral appliance plus oxygen Order of interventions: Sham, Combo, MAD, Oxygen Sham, Combo, MAD, Oxygen No treatment Order of interventions: Sham, Combo, MAD, Oxygen Sham, MAD, Combo, Oxygen Oral appliance Order of interventions: Sham, MAD, Combo, Oxygen Sham, MAD, Combo, Oxygen Oral appliance plus oxygen Order of interventions: Sham, MAD, Combo, Oxygen Sham, MAD, Combo, Oxygen No treatment Order of interventions: Sham, MAD, Combo, Oxygen Sham, MAD, Combo, Oxygen Oxygen Order of interventions: Sham, MAD, Combo, Oxygen Sham, MAD, Oxygen, Combo Oral appliance Order of interventions: Sham, MAD, Oxygen, Combo Sham, MAD, Oxygen, Combo Oxygen Order of interventions: Sham, MAD, Oxygen, Combo Sham, MAD, Oxygen, Combo Oral appliance plus oxygen Order of interventions: Sham, MAD, Oxygen, Combo Sham, MAD, Oxygen, Combo No treatment Order of interventions: Sham, MAD, Oxygen, Combo Sham, Oxygen, Combo, MAD Oral appliance Order of interventions: Sham, Oxygen, Combo, MAD Sham, Oxygen, Combo, MAD Oxygen Order of interventions: Sham, Oxygen, Combo, MAD Sham, Oxygen, Combo, MAD Oral appliance plus oxygen Order of interventions: Sham, Oxygen, Combo, MAD Sham, Oxygen, Combo, MAD No treatment Order of interventions: Sham, Oxygen, Combo, MAD Sham, Oxygen, MAD, Combo Oral appliance Order of interventions: Sham, Oxygen, MAD, Combo Sham, Oxygen, MAD, Combo Oxygen Order of interventions: Sham, Oxygen, MAD, Combo Sham, Oxygen, MAD, Combo Oral appliance plus oxygen Order of interventions: Sham, Oxygen, MAD, Combo Sham, Oxygen, MAD, Combo No treatment Order of interventions: Sham, Oxygen, MAD, Combo
- Primary Outcome Measures
Name Time Method Change in apnea hypopnea index (AHI), percent of baseline. Single night Primary test is difference between combination therapy and oral appliance
- Secondary Outcome Measures
Name Time Method Change in frequency of arousals, percent of baseline. Single night Primary test is difference between combination therapy and oral appliance
Patient reported sleep quality (visual analog scale) Single night Primary test is difference between combination therapy and oral appliance
Morning minus evening systolic blood pressure Single night Primary test is difference between combination therapy and oral appliance
Morning minus evening diastolic blood pressure Single night Primary test is difference between combination therapy and oral appliance
Trial Locations
- Locations (2)
Sleep and Circadian Medicine Laboratory, BASE Facility, Monash University
🇦🇺Notting Hill, Victoria, Australia
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States