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
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.
Study Type
OBSERVATIONAL
Enrollment
76
Class II intraoral devices for snoring and/or obstructive sleep apnea
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
RECRUITINGNumber of participants with adverse events in this entire study.
All safety events will be listed and tabulated for their occurrence rate
Time frame: through study completion, up to 10 weeks
iNAP® Lite-treated clinical success rate
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
Time frame: a treated polysomnography or polygraphy assessment night
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