Pivotal Study of the iNAP® in Adults With OSA

Obstructive Sleep Apnea Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544463
• Other study ID #: iNAP®-TW-1701
• Status: Completed
• Phase: N/A
• Start date: June 6, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: April 2019
• Source: Somnics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Somnics, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with abnormal laboratory values and/or adverse events in this entire study.	All safety events will be listed and tabulated for their occurrence rate	through study completion, up to 8 weeks
Primary	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	Clinical Global Impression of Change (CGI-C)	Global impression changes as rated by the physicians	first treatment night
Secondary	Negative pressure maintenance time (hr)	The time period of iNAP® in providing effective negative pressure within the oral cavity	first treatment night
Secondary	Change of Oxygen Desaturation Index (ODI)** from the Baseline PSG Study compared to the Tx PSG Study	**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.	first treatment night