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

Primary Purpose

Obstructive Sleep Apnea

Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
iNAP® Sleep Therapy System
Sponsored by
Somnics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring OSA, Oral Pressure Therapy (OPT)

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mackay Memorial Hospital, Hsinchu
  • China Medical University Hospital
  • Shin Kong Wu Ho-Su Memorial Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Change from baseline of Apnea-Hypopnea Index (AHI)
The study was terminated. No enough samples for statistical analysis.

Secondary Outcome Measures

Change from baseline of obstructive apnea reduction
The study was terminated. No enough samples for statistical analysis.
Change from baseline of oxygen desaturation index (ODI)
The study was terminated. No enough samples for statistical analysis.
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.

Full Information

First Posted
December 11, 2014
Last Updated
March 15, 2018
Sponsor
Somnics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02324790
Brief Title
Pilot Study of Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea
Official Title
A Multicenter Pilot Study on the Indications of Negative Pressure Sleep Therapy System for the Treatment of Obstructive Sleep Apnea (OSA)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Study Start Date
December 2014 (undefined)
Primary Completion Date
January 13, 2016 (Actual)
Study Completion Date
January 13, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Somnics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
OSA, Oral Pressure Therapy (OPT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
evaluator blind
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treated with iNAP® Sleep Therapy System on the treatment PSG night.
Intervention Type
Device
Intervention Name(s)
iNAP® Sleep Therapy System
Other Intervention Name(s)
Negative Pressre Sleep Therapy System, iNAP®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline of Apnea-Hypopnea Index (AHI)
Description
The study was terminated. No enough samples for statistical analysis.
Time Frame
One treatment night
Secondary Outcome Measure Information:
Title
Change from baseline of obstructive apnea reduction
Description
The study was terminated. No enough samples for statistical analysis.
Time Frame
One treatment night
Title
Change from baseline of oxygen desaturation index (ODI)
Description
The study was terminated. No enough samples for statistical analysis.
Time Frame
One treatment night
Title
Adverse event (AE)/ serious adverse event (SAE) rate and type
Description
During the entire study period, a total of only 9 events were reported by 8 patients.
Time Frame
From informed consent form obtained to the end of study, average of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C.M. Lin, M.D.
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memorial Hospital, Hsinchu
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
111
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

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

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