Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT05527652
Status
Recruiting
Apply to this trial

Conditions

  • Down Syndrome
  • Hypertonia, Muscle
  • Nasal Airway Obstruction
  • Obstructive Sleep Apnea
  • Tolerance
  • Trisomy 21

Eligibility Criteria

Sex
ALL
Age
3 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Self-Supporting Nasopharyngeal Airway (ssNPA) — DEVICE
    The ssNPA device is made of a single piece of flexible, medical-grade silicone. It is inserted through one nostril and extends to the anatomic position bypassing the upper airway obstruction above the epiglottis.

Study Details

The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).

Key Dates

Start date
Nov 16, 2022
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Self-Supporting Nasopharyngeal Airway (ssNPA)
  • No Intervention: Standard of Care
    Waitlist control group: While waiting, participants will continue to receive the treatment they would have had before which will likely include being placed on the waiting list for positive airway pressure (PAP). After a period of being on the waitlist (8 weeks) there is an option to cross-over to the device arm.

Primary Outcome Measure

Apnea-hypopnea index (AHI) [ Time Frame: Up to 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of MichiganAnn ArborMichigan48109
Louise M O'Brien, PhD
[email protected]
734-647-9064
David Zopf, MD (PRINCIPAL_INVESTIGATOR)
Louise O'Brien, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By research site
The University of Michigan· Ann Arbor, MI

Related Studies