Pivotal Study of the iNAP® in Adults With OSA

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

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-06

Study Completion Date

2018-11-01

Brief Summary

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A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of iNAP® Sleep Therapy System in Adults with Obstructive Sleep Apnea (OSA)

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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, the investigators are conducting a prospective, self-controlled, first-night order cross-over and evaluator-blind pivotal study to evaluate the efficacy and safety of iNAP® Sleep Therapy System (iNAP®), a tongue and soft palate retaining intraoral device, in adults with OSA.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treated

iNAP® Sleep Therapy System Treatment Intervention

Group Type EXPERIMENTAL

iNAP® Sleep Therapy System

Intervention Type DEVICE

The iNAP® provides a pressure gradient within the oral cavity, which pulls the tongue toward the upper palate and pulls the soft palate forward in a way that enhances the patency of the upper airway near the pharynx so that upper airway patency can be maintained to prevent sleep-disordered breathing.

Baseline/Control

Self-controlled, pre-treatment baseline condition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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iNAP® Sleep Therapy System

The iNAP® provides a pressure gradient within the oral cavity, which pulls the tongue toward the upper palate and pulls the soft palate forward in a way that enhances the patency of the upper airway near the pharynx so that upper airway patency can be maintained to prevent sleep-disordered breathing.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients able to read and sign on the informed consent form and able to comply with study requirements.
* Body mass index (BMI) \<33 kg/m2
* AHI between 15\~55
* Pass a device feasibility test

Exclusion Criteria

* Obstructed nasal passages
* Hypoxemia (SpO2 \<80%)
* Primary insomnia or other suspected sleep disorder other than OSA
* Muscle diseases, e.g. CSA
* Patients with potential complications of sleep apnea that, in the opinion of the Investigator, may affect the study interpretation or the health or safety of the patients

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No