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Orthoapnea NOA® for Obstructive Sleep Apnea
Study Summary
This trial assesses the effectiveness of a new device for treating sleep apnea, and compares it to other similar devices. Additionally, it looks at patient compliance and any side effects from using the device.
- Obstructive Sleep Apnea
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: MAD therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the aggregate figure of individuals partaking in this experiment?
"Affirmative. The information on clinicaltrials.gov attests to the fact that this research is presently recruiting patients; it was first posted in November 15th 2021, and last edited December 1st 2021 . Fifty participants are necessary for admission from a single medical facility."
Are elderly adults aged 55 and above able to participate in this experiment?
"Qualified participants for this study should range in age from 18 to 79. For those younger than 18, there are 48 other clinical trials available and 235 if the patient is older than 65 years of age."
Are there any remaining opportunities for participants in this research project?
"As per clinicaltrials.gov, this medical trial is in the process of enrollment. The initial posting occurred on November 15th 2021 and was recently edited December 1st 2021."
Am I eligible to register for this clinical experiment?
"This medical study is seeking 50 individuals who have apnea and are between 18 to 79 years of age. Additional eligibility criteria include, but are not limited to: no prior use of a mandibular advancement device (MAD), an OSA diagnosis from a sleep physician based on either polysomnography or home sleep apnea test results in the last year with BMI fluctuating by 10% or more, 8 teeth per arch upon clinical examination, and consenting for participation in this trial."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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