NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About this trial

This pilot study is being done to determine if the nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device can be used in the treatment of OSA in adults. The researchers think that the NPA-OSA device will reduce the number of apneas.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Capacity and willingness to sign consent

Patient willingness to commit to and complete study over a 30-day time period

Confirmed diagnosis of moderate to severe OSA (AHI >= 15)

OSA caused by upper airway obstruction

Disqualifiers

Within 3 months of initiating CPAP use, and actively using CPAP

Supraglottic airway collapse

Distal airway stenosis

Tracheobronchomalacia

Trial design

Design model

Single group

Treatments tested in this trial

  • nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device

    Device

    The NPA-OSA is a flexible, medical-grade silicone, tube-like device that is self-inserted into the user's nasopharyngeal airway through one nostril prior to sleep and worn throughout the night to reduce or alleviate snoring and obstructive sleep apnea.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Nasopharyngeal airway deviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in severity of apnea hypopnea index (AHI)

The AHI is calculated by dividing the number of apnea events by the number of hours of sleep.

Time frame
Baseline (day 0), 30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Wallace H Coulter Center for Translational Research

Collaborator