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

NCT02324790 | Terminated

• 1 other identifier: CSP-1401-CIP
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

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.

Conditions

Obstructive Sleep Apnea

Keywords

OSA, Oral Pressure Therapy (OPT)

Outcome Measures

Primary Outcomes (1)

• Change from baseline of Apnea-Hypopnea Index (AHI)

  The study was terminated. No enough samples for statistical analysis.

  One treatment night

Secondary Outcomes (3)

• Change from baseline of obstructive apnea reduction

  One treatment night

• Change from baseline of oxygen desaturation index (ODI)

  One treatment night

• Adverse event (AE)/ serious adverse event (SAE) rate and type

  From informed consent form obtained to the end of study, average of 4 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: iNAP® Sleep Therapy System

Interventions

iNAP® Sleep Therapy System 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.

Also known as: Negative Pressre Sleep Therapy System, iNAP®

Treatment

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Somnics, Inc.: lead

Study Sites (4)

Mackay Memorial Hospital, Hsinchu

Hsinchu, 300, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, 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

• C.M. Lin, M.D.

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: evaluator blind
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 24, 2014
• Study Start: December 1, 2014
• Primary Completion: January 13, 2016
• Study Completion: January 13, 2016
• Last Updated: March 19, 2018

Record last verified: 2018-03

Locations

TW (4)