Status:
COMPLETED
Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep Apnea, Obstructive
Hypotonia
Eligibility:
All Genders
3-21 years
Phase:
NA
Brief Summary
Children with hypotonic upper airway obstruction have a high prevalence of severe obstructive sleep apnea, which if not treated has significant clinical consequence. Available treatment approaches, su...
Detailed Description
There is a critical need for safe and effective treatment options for persistent obstructive sleep apnea (OSA) in patients with Hypotonic Upper Airway Obstruction (HUAO). HUAO encompass conditions suc...
Eligibility Criteria
Inclusion
- Children with HUAO: This includes those who newly diagnosed with OSA. These children will undergo overnight polysomnography to determine the presence of OSA (AHI\>10 or AHI\>5 with nocturnal hypoxemia defined as SpO2 nadir \<=75%).
- Obstructive sleep apnea on polysomnogram with AHI\>=10
- Presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors)
- Post adeonotonsillectomy or those with contraindications to tonsillectomy.
- obstructive sleep apnea on polysomnogram with AHI\>=10
- Tonsil size 2+ or smaller
- Parent/caregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate.
Exclusion
- AHI ≤10 on polysomnogram without hypoxemia or AHI\<5 with hypoxemia - any reason why ssNPA may not be suitable
- Any medical reason why ssNPA therapy may not be suitable
- Active COVID 19 infections
- ETCO2 or 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 exacerbated by OSA, and those most commonly implicated - Attention Deficit/Hyperactivity Disorder, Conduct Disorder, and Oppositional Defiant Disorder - will not be exclusions. However, more pervasive conditions such as severe autism will be excluded
- 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 tracheobroncomalacia
- Need for anticoagulative therapy
- Bleeding disorder
- Restrictive thoracic disorders
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04846400
Start Date
September 1 2021
End Date
August 30 2022
Last Update
December 28 2023
Active Locations (1)
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1
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109