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Completed

NCT Number: NCT03544463

Pivotal Study of the iNAP® in Adults With OSA

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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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iNAP® Sleep Therapy System

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.

Primary outcomes

  1. iNAP®-treated response rate over the apnea-hypopnea index (AHI)*

    Time frame: first treatment night

    *AHI is the number of apnea/hypopnea events divided by total sleep time (TST), i.e., the number of hours of sleep. The reduction rate of AHI is calculated by dividing the AHI reduction on the Tx PSG Study when compared to the Baseline PSG Study with individual baseline AHI. An AHI reduction rate of 50% is considered responsive, namely, responder. Therefore, an overall ratio of responder to the primary endpoint cohort is the response rate.

Secondary outcomes

  1. Clinical Global Impression of Change (CGI-C)

    Time frame: first treatment night

    Global impression changes as rated by the physicians

  2. Negative pressure maintenance time (hr)

    Time frame: first treatment night

    The time period of iNAP® in providing effective negative pressure within the oral cavity

  3. Change of Oxygen Desaturation Index (ODI)** from the Baseline PSG Study compared to the Tx PSG Study

    Time frame: first treatment night

    **ODI is the event number of oxygen level drops by 3 percent or more from baseline divided by total sleep time (TST), i.e., the number of hours of sleep.

Other outcomes

  1. Number of participants with abnormal laboratory values and/or adverse events in this entire study.

    Time frame: through study completion, up to 8 weeks

    All safety events will be listed and tabulated for their occurrence rate

Sponsors and collaborators

Lead sponsor

Somnics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2018
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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