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New treatment option for Obstructive Sleep Apnea
Official title Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
ClinicalTrials.gov ID: NCT05527652
What this study is testing
- What it's testing
- The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 21
You may be able to join if
- Children with Hypotonic Upper Airway Obstruction (HUAO): This includes those who newly diagnosed with obstructive sleep apnea (OSA). These children...
- All people require the presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or...
- Post adenotonsillectomy or those with contraindications to tonsillectomy.
- Tonsil size 2+ or smaller.
- Parent/caregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate.
You likely can't join if
- AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI\<5 with hypoxemia.
- Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable
- Active Coronavirus (COVID) 19 infections
- End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values \>60 mmHg for \>10% of sleep time on PSG
- Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8...
- Presence of supraglottic airway collapse or more distal airway stenosis or collapse (for example glottic, subglottic stenosis, or concern for distal...
See the full eligibility criteria
- Children with Hypotonic Upper Airway Obstruction (HUAO): This includes those who newly diagnosed with obstructive sleep apnea (OSA). These children will undergo overnight polysomnography to determine the presence of OSA...
- All people require the presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors)
- Post adenotonsillectomy or those with contraindications to tonsillectomy.
- Tonsil size 2+ or smaller.
- Parent/caregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate.
- AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI\<5 with hypoxemia.
- Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable
- Active Coronavirus (COVID) 19 infections
- End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values \>60 mmHg for \>10% of sleep time on PSG
- Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible. Some psychiatric conditions may be provoked or...
- Presence of supraglottic airway collapse or more distal airway stenosis or collapse (for example glottic, subglottic stenosis, or concern for distal airway stenosis or malacia)
- Moderate/severe tracheobronchomalacia
- Need for anticoagulative therapy
- Bleeding disorder
- Restrictive thoracic disorders
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.