Pivotal Study of the iNAP® in Adults With OSA

NCT03544463 | Completed

• 1 other identifier: iNAP®-TW-1701
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

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

  \*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.

  first treatment night

Secondary Outcomes (3)

• Clinical Global Impression of Change (CGI-C)

  first treatment night

• Negative pressure maintenance time (hr)

  first treatment night

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

  first treatment night

Other Outcomes (1)

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

  through study completion, up to 8 weeks

Study Arms (2)

Treated

EXPERIMENTAL

iNAP® Sleep Therapy System Treatment Intervention

Device: iNAP® Sleep Therapy System

Baseline/Control

NO INTERVENTION

Self-controlled, pre-treatment baseline condition

Interventions

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.

Treated

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Somnics, Inc.: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Chia-Mo Lin

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: June 1, 2018
• Study Start: June 6, 2018
• Primary Completion: September 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)