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ssNPA Device for Upper Airway Obstruction
Study Summary
This trial is testing whether a new device can help kids with a breathing condition during sleep.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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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- I experience symptoms like snoring, daytime sleepiness, or hyperactivity.I have a lung condition that restricts my breathing.My child has severe sleep apnea or breathing issues at night confirmed by a sleep study.I have a medical condition that makes using a nasal airway support unsuitable.You have a medical or social situation that could make it hard for you to follow the study plan or attend follow-up appointments. Some psychiatric conditions, like ADHD or conduct disorder, won't be excluded, but severe autism will be excluded.Your carbon dioxide levels during sleep are consistently too high.I have a blockage or narrowing in my upper airway.I have a bleeding disorder.I have had my tonsils removed or cannot have them removed due to health reasons.I have a moderate to severe weakness of the windpipe.You have a sleep test result that shows you have a low number of breathing pauses during sleep without low oxygen levels, or very few breathing pauses with low oxygen levels.I currently have an active COVID-19 infection.My tonsils are not very large.I need medication to prevent blood clots.
- Group 1: Self-Supporting Nasopharyngeal Airway (ssNPA)
- Group 2: Standard of Care
- 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
Are there presently any open opportunities for enrollment in this trial?
"As evidenced by clinicaltrials.gov, this study is open for patient enrollment. It was initially opened on November 4th 2022 and its most recent update occurred six days later."
What is the sample size for this clinical research endeavor?
"Affirmative. The records housed on clinicaltrials.gov affirm that this medical research, which was inaugurated on November 4th 2022, is still open for recruitment purposes. 40 participants are sought from a single centre of care."
What are the primary goals that this clinical experiment is aiming to achieve?
"The primary outcome of this medical trial, measured for a period of up to 16 weeks, is tolerance towards the Self-Supporting Nasopharyngeal Airway (ssNPA). Secondary objectives include sleep quality as calculated by parent report on a scale from 0 to 5 with higher scores indicating improved sleep quality; daytime sleepiness assessed through the Children's Epworth Sleepiness Scale that can range between 0 and 24 points where lower values point at better outcomes; and finally Quality of Life employing dimensions such as Physical Functioning, Emotional Functioning, Social Functioning and School Functioning. The Psychosocial Health Summary Score is derived from"
Are individuals over 20 years old eligible for enrollment in this research project?
"Participants who wish to enroll in this experiment must be between the ages of 3 and 21. For context, there are 68 clinical trials available for minors while 260 exist for senior citizens."
Are there any particular criteria that make someone an ideal subject for this research?
"Patients with hypertonia and muscle issues that fall in the 3-21 year age bracket can sign up for this trial. 40 participants are being recruited alltogether."
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