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
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: iNAP® Sleep Therapy System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||evaluator blind|
|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|
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.
- Change from baseline of Apnea-Hypopnea Index (AHI) [ Time Frame: One treatment night ]The study was terminated. No enough samples for statistical analysis.
- Change from baseline of obstructive apnea reduction [ Time Frame: One treatment night ]The study was terminated. No enough samples for statistical analysis.
- Change from baseline of oxygen desaturation index (ODI) [ Time Frame: One treatment night ]The study was terminated. No enough samples for statistical analysis.
- 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.
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
|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|
|Principal Investigator:||C.M. Lin, M.D.||Shin Kong Wu Ho-Su Memorial Hospital|