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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02324790
• Other study ID #: CSP-1401-CIP
• Status: Terminated
• Phase: N/A
• First received: December 11, 2014
• Last updated: March 15, 2018
• Start date: December 2014
• Est. completion date: January 13, 2016

Study information

• Verified date: March 2018
• Source: Somnics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: January 13, 2016
• Est. primary completion date: January 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Taiwan	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

Sponsors (1)

Lead Sponsor	Collaborator
Somnics, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of Apnea-Hypopnea Index (AHI)	The study was terminated. No enough samples for statistical analysis.	One treatment night
Secondary	Change from baseline of obstructive apnea reduction	The study was terminated. No enough samples for statistical analysis.	One treatment night
Secondary	Change from baseline of oxygen desaturation index (ODI)	The study was terminated. No enough samples for statistical analysis.	One treatment night
Secondary	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