Long-term Evaluation of Nasopharyngeal Airway in Hypotonia

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06614582
Status
Enrolling By Invitation

Conditions

  • Hypotonia, Muscle
  • Nasal Airway Obstruction
  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
3 Years - 23 Years
Healthy Volunteers
Not accepted

Interventions

  • Self-Supporting Nasopharyngeal Airway (ssNPA) — DEVICE
    The ssNPA device is a flexible, medical-grade silicone, nasal tube that is self-inserted into the airway through one nostril and worn during the night. It can also be used during the day. The device works by supporting collapsed airway muscles and keeping the airway open. In addition to wearing the device, study team members will call monthly and collect certain data, and medical information and participants will be asked to have a sleep study at the 12-month visit.

Study Details

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.

Key Dates

Start date
Oct 23, 2024
Status verified
Dec 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Self-Supporting Nasopharyngeal Airway (ssNPA)
    Participants will use the device up to 24 months.

Primary Outcome Measure

Obstructive sleep apnea (OSA) severity measured by the apnea/hypopnea index (AHI) assessed by overnight polysomnography [ Time Frame: Approximately 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109-

Find similar trials in Ann Arbor, MI

By research site
University of Michigan· Ann Arbor, MI

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