Obstructive Sleep Apnea of AdultNCT03559322
Real World Experiences of the iNAP® Lite in OSA Adults in Taiwan
An observational study of Obstructive Sleep Apnea of Adult, run by Somnics, Inc. at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- iNAP® Lite Sleep Therapy System
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with obstructive sleep apnea in Taiwan
Who may be able to join
- Diagnosed with OSA with AHI>5
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111
Chia-Mo Lin, M.D., +88628332211
About this study
Official title: 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
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
Read the detailed description
Obstructive sleep apnea (OSA) impacts sleep quality of patients, which contributes significantly to hypertension, stroke, myocardial infarction and other health problems. Intraoral devices, such as tongue retaining devices, palatal lifting devices and mandibular repositioning devices designed to increase the patency of the airway and to decrease airway obstruction, are used to treat OSA. To this end, we are conducting a prospective, observational, post-market surveillance study to evaluate the long-term safety and efficacy of the iNAP® Lite sleep therapy system (iNAP® Lite), a tongue and soft palate retaining intraoral device, in adults with OSA.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- iNAP® Lite Sleep Therapy System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNAP® Lite Sleep Therapy SystemDevice
Class II intraoral devices for snoring and/or obstructive sleep apnea
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events in this entire study.
All safety events will be listed and tabulated for their occurrence rate
Measured: through study completion, up to 10 weeks
Secondary outcomes (1)
iNAP® Lite-treated clinical success rate
AHI is the number of apnea/hypopnea events divided by total sleep time (TST), i.e., the number of hours of sleep. Clinical success rate is defined as the proportion of patients in the PP cohort with an AHI reduction of >50% and treated AHI <20 on the Tx PSG Study when compared with the baseline
Measured: a treated polysomnography or polygraphy assessment night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 Aug 2019
- Primary completion1 Aug 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Somnics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chung-Chu Chen, Ph.D., Study chair, Somnics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559322
- Sponsor's protocol ID
- iNAP®-TW-1702
- Status last verified
- Sep 2019
- First submitted
- 6 Jun 2018
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: May or may not share the results in a publication.
Publications
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.
PubMed 40019614
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03559322
- Acronym / sponsor ID
- iNAP®-TW-1702
- Conditions
- Obstructive Sleep Apnea of Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Somnics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Obstructive sleep apnea (OSA) impacts sleep quality of patients, which contributes significantly to hypertension, stroke, myocardial infarction and other health problems. Intraoral devices, such as tongue retaining devices, palatal lifting devices and mandibular repositioning devices designed to increase the patency of the airway and to decrease airway obstruction, are used to treat OSA. To this end, we are conducting a prospective, observational, post-market surveillance study to evaluate the long-term safety and efficacy of the iNAP® Lite sleep therapy system (iNAP® Lite), a tongue and soft palate retaining intraoral device, in adults with OSA.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with obstructive sleep apnea in Taiwan
Key inclusion criteria (1 listed)
- Diagnosed with OSA with AHI>5
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iNAP® Lite Sleep Therapy SystemClass II intraoral devices for snoring and/or obstructive sleep apnea | Device | – |
Primary outcome
Number of participants with adverse events in this entire study.
Time frame: through study completion, up to 10 weeks
All safety events will be listed and tabulated for their occurrence rate
1 secondary outcome
iNAP® Lite-treated clinical success rate
Time frame: a treated polysomnography or polygraphy assessment night
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Derived from this study: PubMed 40019614Lin 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.
- Individual participant dataSharing planned: Undecided. May or may not share the results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung-Chu Chen, Ph.D. study chair
Somnics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea of Adult, run by Somnics, Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen-Ning Huang, Ph.D. (+886-3-550-9623 ext. 240, HuangCN@somnics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events in this entire study. (time frame: through study completion, up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03559322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.