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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02324790
Recruitment Status : Terminated
First Posted : December 24, 2014
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Somnics, Inc.

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: iNAP® Sleep Therapy System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: evaluator blind
Primary Purpose: Treatment
Official Title: A Multicenter Pilot Study on the Indications of Negative Pressure Sleep Therapy System for the Treatment of Obstructive Sleep Apnea (OSA)
Study Start Date : December 2014
Actual Primary Completion Date : January 13, 2016
Actual Study Completion Date : January 13, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Treatment
Treated with iNAP® Sleep Therapy System on the treatment PSG night.
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.
Other Names:
  • Negative Pressre Sleep Therapy System
  • iNAP®




Primary Outcome Measures :
  1. Change from baseline of Apnea-Hypopnea Index (AHI) [ Time Frame: One treatment night ]
    The study was terminated. No enough samples for statistical analysis.


Secondary Outcome Measures :
  1. Change from baseline of obstructive apnea reduction [ Time Frame: One treatment night ]
    The study was terminated. No enough samples for statistical analysis.

  2. Change from baseline of oxygen desaturation index (ODI) [ Time Frame: One treatment night ]
    The study was terminated. No enough samples for statistical analysis.

  3. Adverse event (AE)/ serious adverse event (SAE) rate and type [ Time Frame: From informed consent form obtained to the end of study, average of 4 weeks ]
    During the entire study period, a total of only 9 events were reported by 8 patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324790


Locations
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Taiwan
Mackay Memorial Hospital, Hsinchu
Hsinchu, Taiwan, 300
China Medical University Hospital
Taichung, Taiwan, 404
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 111
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Somnics, Inc.
Investigators
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Principal Investigator: C.M. Lin, M.D. Shin Kong Wu Ho-Su Memorial Hospital
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Responsible Party: Somnics, Inc.
ClinicalTrials.gov Identifier: NCT02324790    
Other Study ID Numbers: CSP-1401-CIP
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Keywords provided by Somnics, Inc.:
OSA, Oral Pressure Therapy (OPT)
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases