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| Name | Class |
|---|---|
| California Center for Sleep Disorders | UNKNOWN |
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Non-compliance rates estimated at 50% pose a major issue for CPAP therapy, the primary treatment for OSA. Negative external pressure, applied over the anterior neck under the mandible, has shown encouraging results as an alternative therapy. This study assessed a variety of sizes and shapes of collars and a range of pressures for variable negative external pressure (vNEP) treatment in subjects having moderate OSA to identify combinations that improve the efficacy and comfort of this emerging therapy.
Observations made in this study may be used to plan a more definitive follow-on investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vNEP with various shapes and sizes and overnight PSG | Experimental | Administer vNEP therapy to study participants on the throat's anterior surface with a variable negative pressure ranging from -20 cmH2O up to -35 cmH2O. Assess participants for a reduction in Apnea-Hypopnea Index (AHI) for at least 120 minutes using polysomnography (PSG) and treatment tolerance compared to CPAP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vNEP | Device | Apply vNEP therapy to the anterior surface of the throat with a variable negative pressure ranging from -20 cmH2O up to -35 cmH2O and vNEP devices of varying shapes and sizes. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response | Decrease in AHI <=5 | For 120 min |
| Response | Decrease in AHI of >=50% from baseline | For 120 min |
| Measure | Description | Time Frame |
|---|---|---|
| No response | Did not achieve Primary Outcome Measure | For 120 min |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerrold Kram, MD | California Center for Sleep Disorders | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Center for Sleep Disorders | San Leandro | California | 94578 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18788645 | Background | Lee SA, Amis TC, Byth K, Larcos G, Kairaitis K, Robinson TD, Wheatley JR. Heavy snoring as a cause of carotid artery atherosclerosis. Sleep. 2008 Sep;31(9):1207-13. | |
| 24263288 | Background | Friedman M, Shnowske K, Hamilton C, Samuelson CG, Hirsch M, Pott TR, Yalamanchali S. Mandibular advancement for obstructive sleep apnea: relating outcomes to anatomy. JAMA Otolaryngol Head Neck Surg. 2014 Jan;140(1):46-51. doi: 10.1001/jamaoto.2013.5746. |
| Label | URL |
|---|---|
| Rose RM, Aarestad J, Flicker W et al. Effect of continuous negative external pressure (cNEP) on upper airway (UA) structure and function: implications for obstructive sleep apnea and anesthesia care. Presented at the annual meeting of the America Society | View source |
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| 17589736 | Background | Gelardi M, Del Giudice AM, Cariti F, Cassano M, Farras AC, Fiorella ML, Cassano P. Acoustic pharyngometry: clinical and instrumental correlations in sleep disorders. Braz J Otorhinolaryngol. 2007 Mar-Apr;73(2):257-65. doi: 10.1016/s1808-8694(15)31075-2. |
| 27110692 | Background | Kais SS, Klein KB, Rose RM, Endemann S, Coyle WJ. Continuous negative external pressure (cNEP) reduces respiratory impairment during screening colonoscopy: a pilot study. Endoscopy. 2016 Jun;48(6):584-7. doi: 10.1055/s-0042-102533. Epub 2016 Apr 25. |
| 27529798 | Background | Kendzerska T, Grewal M, Ryan CM. Utility of Acoustic Pharyngometry for the Diagnosis of Obstructive Sleep Apnea. Ann Am Thorac Soc. 2016 Nov;13(11):2019-2026. doi: 10.1513/AnnalsATS.201601-056OC. |
| 8464434 | Background | Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704. |
| 34596039 | Derived | Kram JA, Pelayo R. Variable negative external pressure-an alternative to continuous positive airway pressure for the treatment of obstructive sleep apnea: a pilot study. J Clin Sleep Med. 2022 Jan 1;18(1):305-314. doi: 10.5664/jcsm.9680. |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| 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 |
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