Obstructive Sleep Apnea
Conditions
Brief 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)
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.
Interventions
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.
Sponsors
Somnics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| iNAP®-treated response rate over the apnea-hypopnea index (AHI)* | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression of Change (CGI-C) | first treatment night | Global impression changes as rated by the physicians |
| Negative pressure maintenance time (hr) | first treatment night | The time period of iNAP® in providing effective negative pressure within the oral cavity |
| Change of Oxygen Desaturation Index (ODI)** from the Baseline PSG Study compared to the Tx PSG Study | first treatment night | \*\*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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with abnormal laboratory values and/or adverse events in this entire study. | through study completion, up to 8 weeks | All safety events will be listed and tabulated for their occurrence rate |
Countries
Taiwan
Outcome results
None listed