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Behavioural Intervention
Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
Phase 2
Waitlist Available
Led By Bradley A Edwards, 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
Study 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in apnea hypopnea index (AHI), percent of baseline.
Secondary outcome measures
Change in frequency of arousals, percent of baseline.
Morning minus evening diastolic blood pressure
Morning minus evening systolic blood pressure
+1 moreTrial 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
Oxygen
2013
Completed Phase 4
~12430
Oral appliance
2015
N/A
~30
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,835 Previous Clinical Trials
47,310,630 Total Patients Enrolled
Monash UniversityOTHER
187 Previous Clinical Trials
10,486,551 Total Patients Enrolled
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,790 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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