Obstructive Sleep ApneaNCT03544463
Pivotal Study of the iNAP® in Adults With OSA
A study testing iNAP® Sleep Therapy System in people with Obstructive Sleep Apnea, run by Somnics, Inc. at 1 site in Taiwan.
Trial summary
A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of iNAP® Sleep Therapy System in Adults with Obstructive Sleep Apnea (OSA) Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- iNAP® Sleep Therapy System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jun 2018to 1 Nov 2018
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients able to read and sign on the informed consent form and able to comply with study requirements.
- Body mass index (BMI) <33 kg/m2
- AHI between 15~55
- Pass a device feasibility test
Who cannot join
- Obstructed nasal passages
- Hypoxemia (SpO2 <80%)
- Primary insomnia or other suspected sleep disorder other than OSA
- Muscle diseases, e.g. CSA
- Patients with potential complications of sleep apnea that, in the opinion of the Investigator, may affect the study interpretation or the health or safety of the patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of the iNAP® Sleep Therapy System in Adults With Obstructive Sleep Apnea (OSA)
A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of iNAP® Sleep Therapy System in Adults with Obstructive Sleep Apnea (OSA)
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, the investigators are conducting a prospective, self-controlled, first-night order cross-over and evaluator-blind pivotal study to evaluate the efficacy and safety of iNAP® Sleep Therapy System (iNAP®), a tongue and soft palate retaining intraoral device, in adults with OSA.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- iNAP® Sleep Therapy System
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNAP® Sleep Therapy SystemDevice
The iNAP® provides a pressure gradient within the oral cavity, which pulls the tongue toward the upper palate and pulls the soft palate forward in a way that enhances the patency of the upper airway near the pharynx so that upper airway patency can be maintained to prevent sleep-disordered breathing.
| Study group | Role | What they receive |
|---|---|---|
| Treated | Experimental | iNAP® Sleep Therapy System Treatment Intervention Receives: Device: iNAP® Sleep Therapy System |
| Baseline/Control | No intervention | Self-controlled, pre-treatment baseline condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
iNAP®-treated response rate over the apnea-hypopnea index (AHI)*
*AHI is the number of apnea/hypopnea events divided by total sleep time (TST), i.e., the number of hours of sleep. The reduction rate of AHI is calculated by dividing the AHI reduction on the Tx PSG Study when compared to the Baseline PSG Study with individual baseline AHI. An AHI reduction rate of 50% is considered responsive, namely, responder. Therefore, an overall ratio of responder to the primary endpoint cohort is the response rate.
Measured: first treatment night
Secondary outcomes (3)
Clinical Global Impression of Change (CGI-C)
Global impression changes as rated by the physicians
Measured: first treatment night
Negative pressure maintenance time (hr)
The time period of iNAP® in providing effective negative pressure within the oral cavity
Measured: first treatment night
Change of Oxygen Desaturation Index (ODI)** from the Baseline PSG Study compared to the Tx PSG Study
**ODI is the event number of oxygen level drops by 3 percent or more from baseline divided by total sleep time (TST), i.e., the number of hours of sleep.
Measured: first treatment night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start6 Jun 2018
- Primary completion1 Sep 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somnics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia-Mo Lin, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544463
- Sponsor's protocol ID
- iNAP®-TW-1701
- Status last verified
- Apr 2019
- First submitted
- 15 Mar 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of the iNAP® Sleep Therapy System in Adults With Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT03544463
- Acronym / sponsor ID
- iNAP®-TW-1701
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Somnics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 1 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, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of iNAP® Sleep Therapy System in Adults with Obstructive Sleep Apnea (OSA)
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, the investigators are conducting a prospective, self-controlled, first-night order cross-over and evaluator-blind pivotal study to evaluate the efficacy and safety of iNAP® Sleep Therapy System (iNAP®), a tongue and soft palate retaining intraoral device, in adults with OSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated | Experimental | Device: iNAP® Sleep Therapy SystemiNAP® Sleep Therapy System Treatment Intervention |
| Baseline/Control | No intervention | –Self-controlled, pre-treatment baseline condition |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients able to read and sign on the informed consent form and able to comply with study requirements.
- Body mass index (BMI) <33 kg/m2
- AHI between 15~55
- Pass a device feasibility test
Key exclusion criteria (5 listed)
- Obstructed nasal passages
- Hypoxemia (SpO2 <80%)
- Primary insomnia or other suspected sleep disorder other than OSA
- Muscle diseases, e.g. CSA
- Patients with potential complications of sleep apnea that, in the opinion of the Investigator, may affect the study interpretation or the health or safety of the patients
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® Sleep Therapy SystemThe iNAP® provides a pressure gradient within the oral cavity, which pulls the tongue toward the upper palate and pulls the soft palate forward in a way that enhances the patency of the upper airway near the pharynx so that upper airway patency can be maintained to prevent sleep-disordered breathing. | Device | Treated |
Primary outcome
iNAP®-treated response rate over the apnea-hypopnea index (AHI)*
Time frame: first treatment night
*AHI is the number of apnea/hypopnea events divided by total sleep time (TST), i.e., the number of hours of sleep. The reduction rate of AHI is calculated by dividing the AHI reduction on the Tx PSG Study when compared to the Baseline PSG Study with individual baseline AHI. An AHI reduction rate of 50% is considered responsive, namely, responder. Therefore, an overall ratio of responder to the primary endpoint cohort is the response rate.
3 secondary outcomes
Clinical Global Impression of Change (CGI-C)
Time frame: first treatment night
Negative pressure maintenance time (hr)
Time frame: first treatment night
Change of Oxygen Desaturation Index (ODI)** from the Baseline PSG Study compared to the Tx PSG Study
Time frame: first treatment night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Chia-Mo Lin principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iNAP® Sleep Therapy System in people with Obstructive Sleep Apnea, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 4 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iNAP®-treated response rate over the apnea-hypopnea index (AHI)* (time frame: first treatment night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2019.