Your session is about to expire
← Back to Search
Mandibular Advancement Device
Orthoapnea NOA® for Obstructive Sleep Apnea
N/A
Waitlist Available
Research Sponsored by Isabel Moreno Hay
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 16 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a special mouthpiece called the Orthoapnea NOA® to help people with sleep apnea breathe better at night. It moves the lower jaw forward to keep the airway open. The study will also check how well patients stick to using it and if it causes any jaw problems.
Eligible Conditions
- Obstructive Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
% of Advancement of the Jaw Needed to Achieve Efficacy With the Use of the Mandibular Advancement Device (MAD) Based on the Success Criterion I and II
To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD)
Secondary study objectives
Number of Participants Compliant to the Mandibular Advancement Device (MAD)
Other study objectives
Incidence of Temporomandibular Disorders (TMD) Associated to the Use of the Mandibular Advancement Device (MAD). the Use of the Orthoapnea NOA® Mandibular Advancement Device.
Awards & 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: MAD therapyExperimental Treatment1 Intervention
An NOA® appliance (Orthoapnea S.L., Malaga, Spain) was custom made for each participant at 50% from maximum protrusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Orthoapnea NOA®
2021
N/A
~40
Find a Location
Who is running the clinical trial?
Isabel Moreno HayLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have given informed consent to participate in the study.\nYou have been diagnosed with sleep disorders like trouble sleeping, excessive sleepiness, restless legs, or acting out dreams during sleep.You have a very sensitive gag reflex.You have had an allergic reaction to the material used in the appliance before (Polyamide 12).You have more than 8 teeth in each row of your mouth and your lower jaw can move more than 5 millimeters forwards and backwards.You have been diagnosed with OSA by a sleep physician based on a PSG or HSAT (done >12 months before evaluation date or > 12 months with >10% variation of BMI).You are currently using a combination of therapies, such as PAP therapy or positional therapy, to manage your obstructive sleep apnea (OSA).You have difficulty with coordination or using your hands.You have more than 8 teeth in each row of your mouth, and your lower jaw can move forward and backward more than 5 millimeters.
Research Study Groups:
This trial has the following groups:- Group 1: MAD therapy
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.
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT05139303 — N/A
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger