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

NCT ID: NCT02324790

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-01-13

Brief Summary

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.

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Treated with iNAP® Sleep Therapy System on the treatment PSG night.

Group Type: EXPERIMENTAL

iNAP® Sleep Therapy System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Negative Pressre Sleep Therapy System; iNAP®

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Somnics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

C.M. Lin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital

Locations

Mackay Memorial Hospital, Hsinchu

Hsinchu, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

CSP-1401-CIP

Identifier Type: -

Identifier Source: org_study_id