Evaluation of a Novel Nasal Conformer in Pediatric Patients
NCT ID: NCT06885801
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2025-06-01
2030-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DEVICE_FEASIBILITY
SINGLE
Study Groups
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Standard first, anatomic second
Patients are started with the standard nasal conformer for the first 3 months and then switched to the anatomic conformer for the second 3 months
use of an anatomically designed nasal conformer
this study will evaluate the use of a nasal conformer that has been designed to match the internal airway anatomy of the anterior nose rather than the standard hollow, conical conformer currently available on the market
Anatomic first, standard second
Patients are started with the anatomic nasal conformer for the first 3 months and then switched to the standard conformer for the second 3 months
use of an anatomically designed nasal conformer
this study will evaluate the use of a nasal conformer that has been designed to match the internal airway anatomy of the anterior nose rather than the standard hollow, conical conformer currently available on the market
Interventions
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use of an anatomically designed nasal conformer
this study will evaluate the use of a nasal conformer that has been designed to match the internal airway anatomy of the anterior nose rather than the standard hollow, conical conformer currently available on the market
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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East Tennessee Children's Hospital
OTHER
Responsible Party
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Justin Daggett
Principal Investigator
Central Contacts
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Other Identifiers
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IRB-2025-069
Identifier Type: -
Identifier Source: org_study_id
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