Pilot Study of Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea

A Multicenter Pilot Study on the Indications of Negative Pressure Sleep Therapy System for the Treatment of Obstructive Sleep Apnea (OSA)

This is a pilot study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: iNAP® Sleep Therapy System

Detailed Description

This is an open-lable, single-arm, evaluator-blind and prospective study aimed to evaluate the feasibility of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hsinchu, Taiwan, 300
    • Mackay Memorial Hospital, HsinChu
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 111
    • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of OSA, based on AHI 10~60 (as assessed per baseline PSG).
• Subject understands the study protocol and is willing and able to comply with study requirements and sign the informed consent form.
• BMI ≦ 28.

Exclusion Criteria:

• Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
• Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the device. (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Sleep Therapy System.
• History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
• History of allergic reaction to silicone.
• Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
• Currently working nights, rotating night shifts, planned travel across four or more time zones required during study period, or within two weeks prior to study enrollment, or sleep schedule not compatible with sleep lab practices.
• Current use of medication or other treatment which, in the investigator's opinion, may pose additional risk to the subject or confound the results of the study.
• Potential sleep apnea complications that, in the opinion of the investigator, may affect the health or safety of the participant, including: low blood oxygen, recent near-miss or prior automobile accident due to sleepiness, reported history of severe cardiovascular disease (including New York Heart Association (NYHA) class III or IV heart failure, CAD with angina or myocardial infarction (MI)/stroke in past 6 months, uncontrolled hypertension or hypotension, cardiac arrhythmias), reported respiratory disorders, or use of medication or other treatment which may pose additional risk to the subject or confound the results of the study.
• Female subjects who are pregnant or intend to become pregnant during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Treated with iNAP® Sleep Therapy System on the treatment PSG night.	Device: iNAP® Sleep Therapy System; The iNAP® Sleep Therapy System provides pressure gradient within the oral cavity to pull the tongue toward upper palate and the soft palate forward, which aims to maintain better upper airway patency near the pharynx to prevent sleep-disordered breathing.; Other Names: Negative Pressre Sleep Therapy System; iNAP®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of Apnea-Hypopnea Index (AHI)	The study was terminated. No enough samples for statistical analysis.	One treatment night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of obstructive apnea reduction	The study was terminated. No enough samples for statistical analysis.	One treatment night
Change from baseline of oxygen desaturation index (ODI)	The study was terminated. No enough samples for statistical analysis.	One treatment night
Adverse event (AE)/ serious adverse event (SAE) rate and type	During the entire study period, a total of only 9 events were reported by 8 patients.	From informed consent form obtained to the end of study, average of 4 weeks

Collaborators and Investigators

• Sponsor: Somnics, Inc.
• Investigators: Principal Investigator: C.M. Lin, M.D., Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): January 13, 2016
• Study Completion (Actual): January 13, 2016

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: December 18, 2014
• First Posted (Estimate): December 24, 2014

Study Record Updates

• Last Update Posted (Actual): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: OSA, Oral Pressure Therapy (OPT)
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: CSP-1401-CIP