Redefining Success by Focusing on Failures After Pediatric Hypoglossal Stimulation in Down Syndrome
Objectives/Hypothesis Patients with Down syndrome have a high incidence of obstructive sleep apnea (OSA) and limited treatment options. Hypoglossal stimulation has shown efficacy but has not yet been approved for pediatric populations. Our objective is to characterize the therapy response of adolesc...
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| Veröffentlicht in: | The Laryngoscope 2021-07, Vol.131 (7), p.1663-1669 |
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| creator | Yu, Phoebe K. Jayawardena, Asitha D. L. Stenerson, Matthew Pulsifer, Margaret B. Grieco, Julie A. Abbeduto, Leonard Dedhia, Raj C. Soose, Ryan J. Tobey, Allison Raol, Nikhila Ishman, Stacey L. Shott, Sally R. Cohen, Michael S. Skotko, Brian G. Kinane, Thomas B. Keamy, Donald G. Hartnick, Christopher J. |
| description | Objectives/Hypothesis
Patients with Down syndrome have a high incidence of obstructive sleep apnea (OSA) and limited treatment options. Hypoglossal stimulation has shown efficacy but has not yet been approved for pediatric populations. Our objective is to characterize the therapy response of adolescent patients with down syndrome and severe OSA who underwent hypoglossal stimulation.
Study Design
Prospective longitudinal trial.
Methods
We are conducting a multicenter single‐arm trial of hypoglossal stimulation for adolescent patients with Down syndrome and severe OSA. Interim analysis was performed to compare objective sleep and quality of life outcomes at 12 months postoperatively for the first 20 patients.
Results
The mean age was 15.5 and baseline AHI 24.2. Of the 20 patients, two patients (10.0%) had an AHI under 1.5 at 12 months; nine patients of 20 (45.0%) under five; and 15 patients of 20 (75.0%) under 10. The mean decrease in AHI was 15.1 (P |
| doi_str_mv | 10.1002/lary.29290 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10231383</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2540441177</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4490-cf60d1674095a4713bb1e23f291d3224914df665bb95512d891de74fdb468e3</originalsourceid><addsrcrecordid>eNp9kU9vEzEQxS0EomnhwgdAlrigSlv8dx2fUFQIRYoEajjAyfLa3uDKa6f2LtV-exxSKuDAaaSZ3zzNvAfAC4wuMELkTdB5viCSSPQILDCnuGFS8sdgUYe0WXLy9QSclnKDEBaUo6fghFLSMkbEAphrZ13vo487uJ2McaXAbobrZKZy6KUI19qHKbsCV_3oMvzsrNdj9gZezfu0C6kUHeB29MMU9Ojrgo_wXbqLcDtHm9PgnoEnvQ7FPb-vZ2C7fv_l8qrZfPrw8XK1aQxjEjWmb5HFrWBIcs0Epl2HHaE9kdhSQpjEzPZty7tOco6JXda-E6y3HWuXjp6Bt0fV_dQNzhoXx6yD2mc_VH9U0l79PYn-u9qlHwpXlzBd0qrw-l4hp9vJlVENvhgXgo4uTUUR1rZCEE5FRV_9g96kKcf6nSKcIcYwFgfq_EiZXF3Krn-4BiN1iE4dolO_oqvwyz_vf0B_Z1UBfATufHDzf6TUZnX97Sj6E9OcpOA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2540441177</pqid></control><display><type>article</type><title>Redefining Success by Focusing on Failures After Pediatric Hypoglossal Stimulation in Down Syndrome</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Yu, Phoebe K. ; Jayawardena, Asitha D. L. ; Stenerson, Matthew ; Pulsifer, Margaret B. ; Grieco, Julie A. ; Abbeduto, Leonard ; Dedhia, Raj C. ; Soose, Ryan J. ; Tobey, Allison ; Raol, Nikhila ; Ishman, Stacey L. ; Shott, Sally R. ; Cohen, Michael S. ; Skotko, Brian G. ; Kinane, Thomas B. ; Keamy, Donald G. ; Hartnick, Christopher J.</creator><creatorcontrib>Yu, Phoebe K. ; Jayawardena, Asitha D. L. ; Stenerson, Matthew ; Pulsifer, Margaret B. ; Grieco, Julie A. ; Abbeduto, Leonard ; Dedhia, Raj C. ; Soose, Ryan J. ; Tobey, Allison ; Raol, Nikhila ; Ishman, Stacey L. ; Shott, Sally R. ; Cohen, Michael S. ; Skotko, Brian G. ; Kinane, Thomas B. ; Keamy, Donald G. ; Hartnick, Christopher J.</creatorcontrib><description>Objectives/Hypothesis
Patients with Down syndrome have a high incidence of obstructive sleep apnea (OSA) and limited treatment options. Hypoglossal stimulation has shown efficacy but has not yet been approved for pediatric populations. Our objective is to characterize the therapy response of adolescent patients with down syndrome and severe OSA who underwent hypoglossal stimulation.
Study Design
Prospective longitudinal trial.
Methods
We are conducting a multicenter single‐arm trial of hypoglossal stimulation for adolescent patients with Down syndrome and severe OSA. Interim analysis was performed to compare objective sleep and quality of life outcomes at 12 months postoperatively for the first 20 patients.
Results
The mean age was 15.5 and baseline AHI 24.2. Of the 20 patients, two patients (10.0%) had an AHI under 1.5 at 12 months; nine patients of 20 (45.0%) under five; and 15 patients of 20 (75.0%) under 10. The mean decrease in AHI was 15.1 (P < .001). Patients with postoperative AHI over five had an average baseline OSA‐18 survey score of 3.5 with an average improvement of 1.7 (P = .002); in addition, six of these patients had a relative decrease of apneas compared to hypopneas and seven had an improvement in percentage of time with oxygen saturation below 90%.
Conclusions
Patients with persistently elevated AHI 12 months after hypoglossal implantation experienced improvement in polysomnographic and quality of life outcomes. These results suggest the need for a closer look at physiologic markers for success beyond reporting AHI as the gold standard.
Level of Evidence
4 Laryngoscope, 131:1663–1669, 2021</description><identifier>ISSN: 0023-852X</identifier><identifier>EISSN: 1531-4995</identifier><identifier>DOI: 10.1002/lary.29290</identifier><identifier>PMID: 33264427</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley & Sons, Inc</publisher><subject>Adolescent ; Child ; Down syndrome ; Down Syndrome - complications ; Electric Stimulation Therapy - adverse effects ; Electric Stimulation Therapy - instrumentation ; Electric Stimulation Therapy - statistics & numerical data ; Female ; Humans ; Hypoglossal Nerve ; hypoglossal nerve stimulation ; Implantable Neurostimulators ; Laryngoscopy ; Longitudinal Studies ; Male ; pediatric obstructive sleep apnea ; Pediatrics ; Prospective Studies ; Quality of Life ; Severity of Illness Index ; Sleep apnea ; Sleep Apnea, Obstructive - diagnosis ; Sleep Apnea, Obstructive - etiology ; Sleep Apnea, Obstructive - therapy ; Treatment Failure ; Young Adult</subject><ispartof>The Laryngoscope, 2021-07, Vol.131 (7), p.1663-1669</ispartof><rights>2020 American Laryngological, Rhinological and Otological Society Inc, "The Triological Society" and American Laryngological Association (ALA)</rights><rights>2020 American Laryngological, Rhinological and Otological Society Inc, "The Triological Society" and American Laryngological Association (ALA).</rights><rights>2021 The American Laryngological, Rhinological and Otological Society, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4490-cf60d1674095a4713bb1e23f291d3224914df665bb95512d891de74fdb468e3</citedby><cites>FETCH-LOGICAL-c4490-cf60d1674095a4713bb1e23f291d3224914df665bb95512d891de74fdb468e3</cites><orcidid>0000-0001-8467-3269 ; 0000-0001-5568-0427 ; 0000-0002-6409-7863 ; 0000-0003-0997-9692</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Flary.29290$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Flary.29290$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,777,781,882,1412,27905,27906,45555,45556</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33264427$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yu, Phoebe K.</creatorcontrib><creatorcontrib>Jayawardena, Asitha D. L.</creatorcontrib><creatorcontrib>Stenerson, Matthew</creatorcontrib><creatorcontrib>Pulsifer, Margaret B.</creatorcontrib><creatorcontrib>Grieco, Julie A.</creatorcontrib><creatorcontrib>Abbeduto, Leonard</creatorcontrib><creatorcontrib>Dedhia, Raj C.</creatorcontrib><creatorcontrib>Soose, Ryan J.</creatorcontrib><creatorcontrib>Tobey, Allison</creatorcontrib><creatorcontrib>Raol, Nikhila</creatorcontrib><creatorcontrib>Ishman, Stacey L.</creatorcontrib><creatorcontrib>Shott, Sally R.</creatorcontrib><creatorcontrib>Cohen, Michael S.</creatorcontrib><creatorcontrib>Skotko, Brian G.</creatorcontrib><creatorcontrib>Kinane, Thomas B.</creatorcontrib><creatorcontrib>Keamy, Donald G.</creatorcontrib><creatorcontrib>Hartnick, Christopher J.</creatorcontrib><title>Redefining Success by Focusing on Failures After Pediatric Hypoglossal Stimulation in Down Syndrome</title><title>The Laryngoscope</title><addtitle>Laryngoscope</addtitle><description>Objectives/Hypothesis
Patients with Down syndrome have a high incidence of obstructive sleep apnea (OSA) and limited treatment options. Hypoglossal stimulation has shown efficacy but has not yet been approved for pediatric populations. Our objective is to characterize the therapy response of adolescent patients with down syndrome and severe OSA who underwent hypoglossal stimulation.
Study Design
Prospective longitudinal trial.
Methods
We are conducting a multicenter single‐arm trial of hypoglossal stimulation for adolescent patients with Down syndrome and severe OSA. Interim analysis was performed to compare objective sleep and quality of life outcomes at 12 months postoperatively for the first 20 patients.
Results
The mean age was 15.5 and baseline AHI 24.2. Of the 20 patients, two patients (10.0%) had an AHI under 1.5 at 12 months; nine patients of 20 (45.0%) under five; and 15 patients of 20 (75.0%) under 10. The mean decrease in AHI was 15.1 (P < .001). Patients with postoperative AHI over five had an average baseline OSA‐18 survey score of 3.5 with an average improvement of 1.7 (P = .002); in addition, six of these patients had a relative decrease of apneas compared to hypopneas and seven had an improvement in percentage of time with oxygen saturation below 90%.
Conclusions
Patients with persistently elevated AHI 12 months after hypoglossal implantation experienced improvement in polysomnographic and quality of life outcomes. These results suggest the need for a closer look at physiologic markers for success beyond reporting AHI as the gold standard.
Level of Evidence
4 Laryngoscope, 131:1663–1669, 2021</description><subject>Adolescent</subject><subject>Child</subject><subject>Down syndrome</subject><subject>Down Syndrome - complications</subject><subject>Electric Stimulation Therapy - adverse effects</subject><subject>Electric Stimulation Therapy - instrumentation</subject><subject>Electric Stimulation Therapy - statistics & numerical data</subject><subject>Female</subject><subject>Humans</subject><subject>Hypoglossal Nerve</subject><subject>hypoglossal nerve stimulation</subject><subject>Implantable Neurostimulators</subject><subject>Laryngoscopy</subject><subject>Longitudinal Studies</subject><subject>Male</subject><subject>pediatric obstructive sleep apnea</subject><subject>Pediatrics</subject><subject>Prospective Studies</subject><subject>Quality of Life</subject><subject>Severity of Illness Index</subject><subject>Sleep apnea</subject><subject>Sleep Apnea, Obstructive - diagnosis</subject><subject>Sleep Apnea, Obstructive - etiology</subject><subject>Sleep Apnea, Obstructive - therapy</subject><subject>Treatment Failure</subject><subject>Young Adult</subject><issn>0023-852X</issn><issn>1531-4995</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU9vEzEQxS0EomnhwgdAlrigSlv8dx2fUFQIRYoEajjAyfLa3uDKa6f2LtV-exxSKuDAaaSZ3zzNvAfAC4wuMELkTdB5viCSSPQILDCnuGFS8sdgUYe0WXLy9QSclnKDEBaUo6fghFLSMkbEAphrZ13vo487uJ2McaXAbobrZKZy6KUI19qHKbsCV_3oMvzsrNdj9gZezfu0C6kUHeB29MMU9Ojrgo_wXbqLcDtHm9PgnoEnvQ7FPb-vZ2C7fv_l8qrZfPrw8XK1aQxjEjWmb5HFrWBIcs0Epl2HHaE9kdhSQpjEzPZty7tOco6JXda-E6y3HWuXjp6Bt0fV_dQNzhoXx6yD2mc_VH9U0l79PYn-u9qlHwpXlzBd0qrw-l4hp9vJlVENvhgXgo4uTUUR1rZCEE5FRV_9g96kKcf6nSKcIcYwFgfq_EiZXF3Krn-4BiN1iE4dolO_oqvwyz_vf0B_Z1UBfATufHDzf6TUZnX97Sj6E9OcpOA</recordid><startdate>202107</startdate><enddate>202107</enddate><creator>Yu, Phoebe K.</creator><creator>Jayawardena, Asitha D. L.</creator><creator>Stenerson, Matthew</creator><creator>Pulsifer, Margaret B.</creator><creator>Grieco, Julie A.</creator><creator>Abbeduto, Leonard</creator><creator>Dedhia, Raj C.</creator><creator>Soose, Ryan J.</creator><creator>Tobey, Allison</creator><creator>Raol, Nikhila</creator><creator>Ishman, Stacey L.</creator><creator>Shott, Sally R.</creator><creator>Cohen, Michael S.</creator><creator>Skotko, Brian G.</creator><creator>Kinane, Thomas B.</creator><creator>Keamy, Donald G.</creator><creator>Hartnick, Christopher J.</creator><general>John Wiley & Sons, Inc</general><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-8467-3269</orcidid><orcidid>https://orcid.org/0000-0001-5568-0427</orcidid><orcidid>https://orcid.org/0000-0002-6409-7863</orcidid><orcidid>https://orcid.org/0000-0003-0997-9692</orcidid></search><sort><creationdate>202107</creationdate><title>Redefining Success by Focusing on Failures After Pediatric Hypoglossal Stimulation in Down Syndrome</title><author>Yu, Phoebe K. ; Jayawardena, Asitha D. L. ; Stenerson, Matthew ; Pulsifer, Margaret B. ; Grieco, Julie A. ; Abbeduto, Leonard ; Dedhia, Raj C. ; Soose, Ryan J. ; Tobey, Allison ; Raol, Nikhila ; Ishman, Stacey L. ; Shott, Sally R. ; Cohen, Michael S. ; Skotko, Brian G. ; Kinane, Thomas B. ; Keamy, Donald G. ; Hartnick, Christopher J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4490-cf60d1674095a4713bb1e23f291d3224914df665bb95512d891de74fdb468e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adolescent</topic><topic>Child</topic><topic>Down syndrome</topic><topic>Down Syndrome - complications</topic><topic>Electric Stimulation Therapy - adverse effects</topic><topic>Electric Stimulation Therapy - instrumentation</topic><topic>Electric Stimulation Therapy - statistics & numerical data</topic><topic>Female</topic><topic>Humans</topic><topic>Hypoglossal Nerve</topic><topic>hypoglossal nerve stimulation</topic><topic>Implantable Neurostimulators</topic><topic>Laryngoscopy</topic><topic>Longitudinal Studies</topic><topic>Male</topic><topic>pediatric obstructive sleep apnea</topic><topic>Pediatrics</topic><topic>Prospective Studies</topic><topic>Quality of Life</topic><topic>Severity of Illness Index</topic><topic>Sleep apnea</topic><topic>Sleep Apnea, Obstructive - diagnosis</topic><topic>Sleep Apnea, Obstructive - etiology</topic><topic>Sleep Apnea, Obstructive - therapy</topic><topic>Treatment Failure</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yu, Phoebe K.</creatorcontrib><creatorcontrib>Jayawardena, Asitha D. L.</creatorcontrib><creatorcontrib>Stenerson, Matthew</creatorcontrib><creatorcontrib>Pulsifer, Margaret B.</creatorcontrib><creatorcontrib>Grieco, Julie A.</creatorcontrib><creatorcontrib>Abbeduto, Leonard</creatorcontrib><creatorcontrib>Dedhia, Raj C.</creatorcontrib><creatorcontrib>Soose, Ryan J.</creatorcontrib><creatorcontrib>Tobey, Allison</creatorcontrib><creatorcontrib>Raol, Nikhila</creatorcontrib><creatorcontrib>Ishman, Stacey L.</creatorcontrib><creatorcontrib>Shott, Sally R.</creatorcontrib><creatorcontrib>Cohen, Michael S.</creatorcontrib><creatorcontrib>Skotko, Brian G.</creatorcontrib><creatorcontrib>Kinane, Thomas B.</creatorcontrib><creatorcontrib>Keamy, Donald G.</creatorcontrib><creatorcontrib>Hartnick, Christopher J.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The Laryngoscope</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yu, Phoebe K.</au><au>Jayawardena, Asitha D. L.</au><au>Stenerson, Matthew</au><au>Pulsifer, Margaret B.</au><au>Grieco, Julie A.</au><au>Abbeduto, Leonard</au><au>Dedhia, Raj C.</au><au>Soose, Ryan J.</au><au>Tobey, Allison</au><au>Raol, Nikhila</au><au>Ishman, Stacey L.</au><au>Shott, Sally R.</au><au>Cohen, Michael S.</au><au>Skotko, Brian G.</au><au>Kinane, Thomas B.</au><au>Keamy, Donald G.</au><au>Hartnick, Christopher J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Redefining Success by Focusing on Failures After Pediatric Hypoglossal Stimulation in Down Syndrome</atitle><jtitle>The Laryngoscope</jtitle><addtitle>Laryngoscope</addtitle><date>2021-07</date><risdate>2021</risdate><volume>131</volume><issue>7</issue><spage>1663</spage><epage>1669</epage><pages>1663-1669</pages><issn>0023-852X</issn><eissn>1531-4995</eissn><abstract>Objectives/Hypothesis
Patients with Down syndrome have a high incidence of obstructive sleep apnea (OSA) and limited treatment options. Hypoglossal stimulation has shown efficacy but has not yet been approved for pediatric populations. Our objective is to characterize the therapy response of adolescent patients with down syndrome and severe OSA who underwent hypoglossal stimulation.
Study Design
Prospective longitudinal trial.
Methods
We are conducting a multicenter single‐arm trial of hypoglossal stimulation for adolescent patients with Down syndrome and severe OSA. Interim analysis was performed to compare objective sleep and quality of life outcomes at 12 months postoperatively for the first 20 patients.
Results
The mean age was 15.5 and baseline AHI 24.2. Of the 20 patients, two patients (10.0%) had an AHI under 1.5 at 12 months; nine patients of 20 (45.0%) under five; and 15 patients of 20 (75.0%) under 10. The mean decrease in AHI was 15.1 (P < .001). Patients with postoperative AHI over five had an average baseline OSA‐18 survey score of 3.5 with an average improvement of 1.7 (P = .002); in addition, six of these patients had a relative decrease of apneas compared to hypopneas and seven had an improvement in percentage of time with oxygen saturation below 90%.
Conclusions
Patients with persistently elevated AHI 12 months after hypoglossal implantation experienced improvement in polysomnographic and quality of life outcomes. These results suggest the need for a closer look at physiologic markers for success beyond reporting AHI as the gold standard.
Level of Evidence
4 Laryngoscope, 131:1663–1669, 2021</abstract><cop>Hoboken, USA</cop><pub>John Wiley & Sons, Inc</pub><pmid>33264427</pmid><doi>10.1002/lary.29290</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-8467-3269</orcidid><orcidid>https://orcid.org/0000-0001-5568-0427</orcidid><orcidid>https://orcid.org/0000-0002-6409-7863</orcidid><orcidid>https://orcid.org/0000-0003-0997-9692</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | The Laryngoscope, 2021-07, Vol.131 (7), p.1663-1669 |
| issn | 0023-852X 1531-4995 |
| language | eng |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adolescent Child Down syndrome Down Syndrome - complications Electric Stimulation Therapy - adverse effects Electric Stimulation Therapy - instrumentation Electric Stimulation Therapy - statistics & numerical data Female Humans Hypoglossal Nerve hypoglossal nerve stimulation Implantable Neurostimulators Laryngoscopy Longitudinal Studies Male pediatric obstructive sleep apnea Pediatrics Prospective Studies Quality of Life Severity of Illness Index Sleep apnea Sleep Apnea, Obstructive - diagnosis Sleep Apnea, Obstructive - etiology Sleep Apnea, Obstructive - therapy Treatment Failure Young Adult |
| title | Redefining Success by Focusing on Failures After Pediatric Hypoglossal Stimulation in Down Syndrome |
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