Clinical trial 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 study wants to see if a special nasal tube can help children with low muscle tone breathe better while sleeping.
- Who it's for
- This study is looking for children with Down syndrome who have weak muscles and block their airway when they sleep.
- What's involved
- Participants will use a self-supporting nasal tube to keep their airway open during sleep.
- Time commitment
- The source text does not specify the duration or visit schedule for this study.
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).
- 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).
- 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.
- 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 is enrolling
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Ann Arbor, Michigan, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.