Obstructive Sleep Apnea (OSA)
Conditions
Interventions
Intervention group:iNAP therapy
Sponsors
Eye and Otolaryngology Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
10 Years to 19 Years
Inclusion criteria
Inclusion criteria: The participants must meet all of the following criteria: 1. The participants must be able to read and sign the informed consent form, and be able to follow the trial procedures; 2. Age between 10 and 19 years old, both genders are acceptable; 3. Body Mass Index (BMI) = 1; 5. The participants must be able to pass the equipment feasibility test.
Exclusion criteria
Exclusion criteria: Subjects will not be included in this study if they meet any of the following criteria: 1. Subjects who are allergic to silicone. 2. Subjects with nasal obstruction that prevents breathing through the nose when the mouth is closed. 3. Subjects who have nearly had a car accident due to sleepiness in the recent past or have had a car accident due to sleepiness. 4. Subjects with hypoxemia (SpO2 < 80%) not due to OSA caused by cardiac disease or severe pulmonary/respiratory diseases (such as interstitial lung disease, pneumothorax, pneumonia, etc.) within the last 6 months. 5. Subjects with asthma. 6. Subjects with primary insomnia or any other sleep disorders. 7. Subjects with muscle diseases, central nervous system diseases, or chronic neurological diseases, including central sleep apnea (defined as central apnea index = 5 events/hour or central sleep apnea constituting at least 50% of the total AHI). 8. Subjects who are currently participating in other clinical trials. 9. Subjects whom the investigator considers to have potential complications of sleep apnea that may affect the interpretation of the study results or the health or safety of the subject, including but not limited to: narcolepsy, restless legs syndrome, nasopharyngeal cancer, end-stage renal failure, a history of severe cardiovascular disease (including New York Heart Association Class III or IV heart failure, coronary artery disease with angina or myocardial infarction/stroke within the last 6 months, uncontrolled hypertension or hypotension or arrhythmia), unstable heart or kidney transplant, use of medications or other treatments that may confound study results or pose additional risks to the subject, such as oral anticoagulants or other medications that make the subject prone to tongue bleeding. 10.Primary snoring
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Polysomnography;Alertness test system;Obstructive Apnea-Hypopnea Index;Apnea-hypopnea index;Maximum apnea duration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep diary;Pediatric Daytime Sleepiness Scale;Chinese Perceived Stress Scale;Center for Epidemiologic Studies Depression Scale;OSA-18 Questionnaire for Pediatric OSAHS;Sleep architecture; | — |
Countries
China
Contacts
Public ContactHuang Jingjing
Eye and Otolaryngology Hospital Affiliated to Fudan University
Outcome results
None listed