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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61HL151952 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Supporting Nasopharyngeal Airway (ssNPA) | Experimental |
| |
| Standard of Care | No Intervention | Waitlist control group: While waiting, participants will continue to receive the treatment they would have had before which will likely include being placed on the waiting list for positive airway pressure (PAP). After a period of being on the waitlist (8 weeks) there is an option to cross-over to the device arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Supporting Nasopharyngeal Airway (ssNPA) | Device | The ssNPA device is made of a single piece of flexible, medical-grade silicone. It is inserted through one nostril and extends to the anatomic position bypassing the upper airway obstruction above the epiglottis. |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea index (AHI) | Measured during the polysomnogram | Up to 16 weeks |
| Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance | Measured by self report. Likert scale 0-5 (higher score is better) | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality | Higher score in parent report of sleep quality on scale 0-5 (higher score is better) | Up to 16 weeks |
| Snoring frequency | As reported by participant/care taker in survey given daily. Snoring frequency is rated on a Likert scale 1-5 where 5 indicates snoring more frequently. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David A Zopf, MD | Contact | 608-262-7181 | dazopf@wisc.edu | |
| Louise M O'Brien, PhD | Contact | 734-647-9064 | louiseo@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| David A Zopf, MD | The University of Wisconsin | Principal Investigator |
| Louise M O'Brien, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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Eligible patients will be randomized 1:1 to receive (1) immediate therapy with the ssNPA device or (2) a waitlist control group who will receive standard of care (SoC) for the first 8 weeks and then be offered the ssNPA at week 8 for the rest of the study period (till week 16).
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Aggregate and stratified outcomes will be revealed only to the unblinded statisticians with a firewall related to outcomes between statistician and investigators. Dr. Zopf will be blinded to all aggregate/stratified outcomes and Dr. O'Brien will be blinded to polysomnography and quality of life outcomes.
| Up to 16 weeks |
| Daytime sleepiness | Measured using the children's Epworth Sleepiness Scale - The Epworth Sleepiness Scale is a self-administered form with eight items investigating sleep propensity in different real-life situations during the preceding months. Each item can received 0-3 points, thus the final score ranges from 0 (best score) to 24 (worse score). | Up to 16 weeks |
| Quality of life as indicated by the dimensions of the PedsQL (pediatric quality of life) instrument. | There are several dimensions of the PedsQL: Physical Functioning, Emotional Functioning, Social Functioning and School Functioning. Each domain will be scored on a scale of 0 (never have problems) to 4 (almost always have problems) and transformed on a scale of 0-100 by reverse scoring (0=100, 1=75, 2=50, 3=25, 4=0). Psychosocial Health Summary Score is the sum of the items over the number of items answered in the Emotional, Social, and School Functioning scales. Physical Health Summary Score is the Physical Functioning Scale Score. The total quality of life score is the sum of all the items over the number of items answered on all scales. | Up to 16 weeks |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D009122 | Muscle Hypertonia |
| D015508 | Nasal Obstruction |
| D004314 | Down Syndrome |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009668 | Nose Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D010038 | Otorhinolaryngologic Diseases |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D012818 | Signs and Symptoms, Respiratory |
| D001523 | Mental Disorders |
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