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

Somnics, Inc.4 sites in 1 country34 target enrollmentDecember 2014

ConditionsObstructive Sleep Apnea

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obstructive Sleep Apnea
Sponsor: Somnics, Inc.
Enrollment: 34
Locations: 4
Primary Endpoint: Change from baseline of Apnea-Hypopnea Index (AHI)
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

January 13, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Somnics, Inc.

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Change from baseline of Apnea-Hypopnea Index (AHI)

Time Frame: One treatment night

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

Secondary Outcomes

Change from baseline of oxygen desaturation index (ODI)(One treatment night)
Change from baseline of obstructive apnea reduction(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)