Clinical trial NCT06614582: Long-term Evaluation of Nasopharyngeal Airway in Hypotonia
Official title: Long-term Evaluation of Nasopharyngeal Airway in Hypotonia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hypotonia, Muscle
Obstructive Sleep Apnea
Nasal Airway Obstruction
Keywords: Self-Supporting Nasopharyngeal Airway (ssNPA)
Sleep study
Difficulty breathing
Obstructive Sleep Apnea
Cerebral Palsy
Down syndrome
Trisomy 21
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group intervention for participants who have completed NCT05527652 (Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia)
Primary purpose: TREATMENT

Brief summary: This research is studying the long term use of a nasal airway device (self-supporting nasopharyngeal airway; "ssNPA") in children with hypotonic upper airway obstruction to learn about its effectiveness and tolerability as a treatment for obstructive sleep apnea.


Eligibility criteria: Inclusion Criteria:

* Children with Hypotonic Upper Airway Obstruction (HUAO) that took part in the original study (HUM00189669/NCT04846400 or HUM00220966/NCT05527652 trials)
* Willingness to continue device usage.
* Confirmed diagnosis of OSA (apnea/hypopnea index; AHI \&gt; 10 or AHI \&gt;5 with lowest oxygen level ≤75%)
* At least one symptom of OSA (such as frequent snoring, daytime sleepiness, or hyperactive/inattentive behaviors)
* Previous adenotonsillectomy (unless tonsillectomy not possible)
* Tonsil size 2+ or smaller

Exclusion Criteria:

* Participants that were non-compliant with the Self-Supporting Nasopharyngeal Airway (ssNPA) device during participation in the parent study listed above
* Any medical reason why ssNPA therapy may not be suitable
* Active COVID 19 infections Moderate/severe tracheobronchomalacia
* Need for anticoagulative therapy
* Bleeding disorder
* Restrictive thoracic disorders

Primary outcomes:
measure: Obstructive sleep apnea (OSA) severity measured by the apnea/hypopnea index (AHI) assessed by overnight polysomnography
timeFrame: Approximately 1 year
measure: Long term device tolerability assessed by self-report from caregivers
timeFrame: 2 years
Secondary outcomes:
measure: Long-term impact on sleep quality will be assessed by the mean score on the parent report of sleep quality
timeFrame: 1-2 years
measure: Long-term impact on daytime sleepiness will be assessed by the mean score on the children's Epworth Sleepiness Scale (ESS)
timeFrame: 1-2 years
measure: Long-term impact on quality of life will be assessed with the OSA-18
timeFrame: 1-2 years
measure: Family Impact Questionnaire (FIQ)
timeFrame: 1-2 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University Michigan
name: Louise M O&#39;Brien, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Powell AR, Srinivasan S, Helman JL, Li AD, O'Brien LM, Shih A, Plott JS, Zopf DA. Novel treatment for hypotonic airway obstruction and severe obstructive sleep apnea using a nasopharyngeal airway device with 3D printing innovation. J Clin Sleep Med. 2022 Oct 1;18(10):2497-2502. doi: 10.5664/jcsm.10202.