Real World Experiences of the iNAP® Lite in OSA Adults in Taiwan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-12-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea of Adult

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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iNAP® Lite Sleep Therapy System

Class II intraoral devices for snoring and/or obstructive sleep apnea

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No