Obstructive Sleep Apnea of Adult
Conditions
Brief summary
A Prospective, Observational, Post-market Surveillance Study to Evaluate the Long-term Safety and Efficacy of the iNAP® Lite Sleep Therapy System in Adults with Obstructive Sleep Apnea
Detailed description
Obstructive sleep apnea (OSA) impacts sleep quality of patients, which contributes significantly to hypertension, stroke, myocardial infarction and other health problems. Intraoral devices, such as tongue retaining devices, palatal lifting devices and mandibular repositioning devices designed to increase the patency of the airway and to decrease airway obstruction, are used to treat OSA. To this end, we are conducting a prospective, observational, post-market surveillance study to evaluate the long-term safety and efficacy of the iNAP® Lite sleep therapy system (iNAP® Lite), a tongue and soft palate retaining intraoral device, in adults with OSA.
Interventions
DEVICEiNAP® Lite Sleep Therapy System
Class II intraoral devices for snoring and/or obstructive sleep apnea
Sponsors
Somnics, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with OSA with AHI\>5
Exclusion criteria
* Patients with central sleep apnea (CSA). * Patients with have severe respiratory disorders such as pulmonary diseases, pneumothorax, etc. * Patients with loose teeth or advanced periodontal disease. * Patients with pathologically low blood pressure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events in this entire study. | through study completion, up to 10 weeks | All safety events will be listed and tabulated for their occurrence rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| iNAP® Lite-treated clinical success rate | a treated polysomnography or polygraphy assessment night | AHI is the number of apnea/hypopnea events divided by total sleep time (TST), i.e., the number of hours of sleep. Clinical success rate is defined as the proportion of patients in the PP cohort with an AHI reduction of \>50% and treated AHI \<20 on the Tx PSG Study when compared with the baseline |
Countries
Taiwan
Contacts
Primary ContactChen-Ning Huang, Ph.D.
Outcome results
None listed