N/A
N=2
Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia
Sleep Apnea, Obstructive · Hypotonia · Child, Only
Bottom Line
View on ClinicalTrials.gov: NCT04846400 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Ability to Tolerate Measured by Percent of Participants With Protocol Goal — 50 percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ssNPA (Device)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ability to Tolerate Measured by Percent of Participants With Protocol Goal |
50 | — |
| PRIMARY Comfort as Measured by Percent of Participants With Protocol Objective Score |
100 | — |
| PRIMARY Ease of Use as Indicated by Percent of Participants Whose Parents Responded Favorably to Device Use, With Protocol Goal |
100 | — |
| SECONDARY Snoring |
— | — |
| SECONDARY Change in Daytime Sleepiness as Shown by Number of Participants Who Had a Reduction in Their Epworth Sleepiness Scale Score |
1 | — |
| SECONDARY Sleep Quality, as Measured by Number of Participants With Parent Identified Improved Sleep |
2 | — |
| SECONDARY Insertion Protocol Optimization as Measured by Percent of Participants Who Found Insertion Relatively Easy |
100 | — |
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, such as surgery and positive airway pressure, show limited efficacy and adherence. The multidisciplinary team has developed and now proposes to further test a non-surgical, well-tolerated nasopharyngeal airway device that in initial patients has resolved even extremely severe obstructive sleep apnea, and improved patient and family quality of life.
Eligibility Criteria
Inclusion Criteria
- 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 =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 Criteria
- AHI ≤10 on polysomnogram without hypoxemia or AHI 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
Data sourced from ClinicalTrials.gov (NCT04846400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.