Real World Experiences of the iNAP® Lite in OSA Adults in Taiwan
A Prospective, Observational, Post-market Surveillance Study to Evaluate the Long-term Safety and Efficacy of the iNAP® Sleep Therapy System in Adults With Obstructive Sleep Apnea
1 other identifier
observational
76
1 country
1
Brief Summary
A Prospective, Observational, Post-market Surveillance Study to Evaluate the Long-term Safety and Efficacy of the iNAP® Lite Sleep Therapy System in Adults with Obstructive Sleep Apnea
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2018
CompletedFirst Posted
Study publicly available on registry
June 18, 2018
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedSeptember 23, 2019
September 1, 2019
2 years
June 6, 2018
September 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events in this entire study.
All safety events will be listed and tabulated for their occurrence rate
through study completion, up to 10 weeks
Secondary Outcomes (1)
iNAP® Lite-treated clinical success rate
a treated polysomnography or polygraphy assessment night
Interventions
Class II intraoral devices for snoring and/or obstructive sleep apnea
Eligibility Criteria
Adults with obstructive sleep apnea in Taiwan
You may qualify if:
- Diagnosed with OSA with AHI\>5
You may not qualify if:
- Patients with central sleep apnea (CSA).
- Patients with have severe respiratory disorders such as pulmonary diseases, pneumothorax, etc.
- Patients with loose teeth or advanced periodontal disease.
- Patients with pathologically low blood pressure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Somnics, Inc.lead
Study Sites (1)
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111, Taiwan
Related Publications (1)
Lin HY, Nien CT, Chen CC, Hong II, Lin C, Lin CM. Optimizing treatment of the novel intra-oral negative pressure for obstructive sleep apnea. Sleep Breath. 2025 Feb 28;29(1):115. doi: 10.1007/s11325-025-03263-w.
PMID: 40019614DERIVED
Study Officials
- STUDY CHAIR
Chung-Chu Chen, Ph.D.
Somnics, Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2018
First Posted
June 18, 2018
Study Start
August 1, 2019
Primary Completion
August 1, 2021
Study Completion
December 30, 2021
Last Updated
September 23, 2019
Record last verified: 2019-09