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Behavioural Intervention
Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
Phase 2
Waitlist Available
Led By Scott A Sands, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up single night
Awards & highlights
No Placebo-Only Group
Summary
This trial will help determine if supplemental oxygen can help those with sleep apnea who use oral appliances, and if different types of sleep apnea respond differently to the two treatments.
Eligible Conditions
- Obstructive Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ single night
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~single night
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in apnea hypopnea index (AHI), percent of baseline.
Secondary study objectives
Change in frequency of arousals, percent of baseline.
Morning minus evening diastolic blood pressure
Morning minus evening systolic blood pressure
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: All patientsExperimental Treatment4 Interventions
Patients will receive all four interventions in randomized order.
Note: Data will not be analyzed separately for the 16 cross-over combinations of intervention order:
Interventions: Oral appliance \| Oral appliance plus oxygen \| Oxygen \| No treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral appliance
2015
N/A
~30
Oxygen
2013
Completed Phase 4
~12210
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,922 Previous Clinical Trials
47,760,698 Total Patients Enrolled
Monash UniversityOTHER
197 Previous Clinical Trials
10,589,948 Total Patients Enrolled
American Heart AssociationOTHER
344 Previous Clinical Trials
4,971,365 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have congestive heart failure.You have a neurological condition that may affect your ability to sleep or breathe, such as myasthenia gravis, Alzheimer's, or Parkinson's.You have serious health problems related to your heart, kidneys, lungs, or nerves.You have trouble sleeping or other sleep problems not related to breathing.You cannot sleep on your back.You are afraid of being in small or enclosed spaces.You have been diagnosed with sleep apnea or it is suspected because of your snoring.You are taking certain medications that can seriously affect your breathing.You have dental issues that make it hard for you to use the oral appliance, or you have problems with your jaw joint.You are allergic to lidocaine or oxymetazoline HCl.
Research Study Groups:
This trial has the following groups:- Group 1: All patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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