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| ID | Type | Description | Link |
|---|---|---|---|
| J3R-MC-YDAO | Other Identifier | Eli Lilly and Company | |
| J3R-MC-YSA1 | Other Identifier | Eli Lilly and Company | |
| J3R-MC-YSA2 | Other Identifier | Eli Lilly and Company | |
| 2025-523769-11-00 | EU Trial (CTIS) Number |
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The purpose of the studies is to evaluate the efficacy and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight. YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2. Study YSA1 will include participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy and study YSA2 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.
Participants will be assigned to the Intervention-Specific Appendix (ISA) that reflects their current PAP usage. Participation in the study will last about 76 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eloralintide (YSA1) | Experimental | Participants will receive eloralintide subcutaneously (SC) |
|
| Placebo (YSA1) | Placebo Comparator | Participants will receive placebo SC |
|
| Eloralintide (YSA2) | Experimental | Participants will receive eloralintide SC |
|
| Placebo (YSA2) | Placebo Comparator | Participants will receive placebo SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eloralintide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 64 | |
| Change from Baseline in Apnea-Hypopnea Index (AHI) | Baseline, Week 64 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 64 | |
| Percent Change from Baseline in Triglycerides | Baseline, Week 64 | |
| Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP) |
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Inclusion Criteria:
For YSA1 Participants:
For YSA2 Participants:
Exclusion Criteria:
Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >1 year before screening)
Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery that still may affect breathing at time of screening
Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
Have had within 90 days prior to screening:
Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure
Have taken medications or alternative remedies intended for weight loss within 90 days of screening
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cullman Clinical Trials | Recruiting | Cullman | Alabama | 35055 | United States |
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| Label | URL |
|---|---|
| A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight (ENLIGHTEN-3) | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
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| Placebo | Drug | Administered SC |
|
| Baseline, Week 64 |
| Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-Score | Baseline, Week 64 |
| Achievement of AHI <5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 | Baseline, Week 64 |
| Percent Change from Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB) | Baseline, Week 64 |
| Number of Participants who Achieve ≥50% decrease in AHI | Baseline, Week 64 |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 64 |
| Change from Baseline in Fasting Glucose | Baseline, Week 64 |
| Change from Baseline in ESS Score | Baseline, Week 64 |
| Change from Baseline in Short Form-36 (SF-36 v2) Scores | Baseline, Week 64 |
| Change from Baseline in EQ-5D-5L Scores | Baseline, Week 64 |
| Percent Change from Baseline in Fasting Insulin | Baseline, Week 64 |
| Change from Baseline in Waist Circumference | Baseline, Week 64 |
| Change in Medication Use | Baseline, Week 64 |
| Achievement of Improved Categorical Shift in Patient Global Impression of Severity-Obstructive Sleep Apnea (PGIS-OSA) | Baseline, Week 64 |
| Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss) | Baseline through Week 64 |
| PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss) | Baseline through Week 64 |
| Ark Clinical Research | Recruiting | Long Beach | California | 90815 | United States |
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| Collaborative Neuroscience Research, LLC | Recruiting | Los Alamitos | California | 90720 | United States |
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| Artemis Institute for Clinical Research | Recruiting | Riverside | California | 92503 | United States |
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| Care Access - Aurora | Recruiting | Aurora | Colorado | 80012 | United States |
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| Flourish Research - Miami, LLC | Recruiting | Miami | Florida | 33135 | United States |
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| PharmaDev Clinical Research Institute, LLC | Recruiting | Miami | Florida | 33176 | United States |
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| Emerald Coast Neurology - Airport Boulevard | Recruiting | Pensacola | Florida | 32504 | United States |
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| Teak Research Consults | Recruiting | Lawrenceville | Georgia | 30043 | United States |
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| EBGS Clinical Research Center | Recruiting | Snellville | Georgia | 30078 | United States |
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| Care Access - Shreveport 2 | Recruiting | Shreveport | Louisiana | 71105 | United States |
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| Flourish Research - Bowie | Recruiting | Bowie | Maryland | 20715 | United States |
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| Revive Research Institute, Inc. | Recruiting | Southfield | Michigan | 48075 | United States |
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| Headlands Research-Twin Cities | Recruiting | Maplewood | Minnesota | 55109 | United States |
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| Clayton Sleep Institute - St. Louis - Tesson Ferry Road | Recruiting | St Louis | Missouri | 63123 | United States |
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| Palm Research Center Tenaya | Recruiting | Las Vegas | Nevada | 89128 | United States |
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| The Sleep Spot - Maimonides | Recruiting | Albuquerque | New Mexico | 87107 | United States |
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| Rochester Clinical Research - Buffalo | Recruiting | Buffalo | New York | 14127 | United States |
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| CTI Clinical Research Center | Recruiting | Cincinnati | Ohio | 45212 | United States |
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| Bogan Sleep Consultants | Recruiting | Columbia | South Carolina | 29201 | United States |
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| FutureSearch Trials of Neurology | Recruiting | Austin | Texas | 78731 | United States |
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| Sleep Therapy Research Center | Recruiting | San Antonio | Texas | 78229 | United States |
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| Consano Clinical Research, LLC | Recruiting | Shavano Park | Texas | 78231 | United States |
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| Cicemo Srl | Not yet recruiting | Buenos Aires | 1424 | Argentina |
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| Stat Research S.A. | Not yet recruiting | Buenos Aires | C1023AAB | Argentina |
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| Centro de Investigaciones Metabólicas (CINME) | Not yet recruiting | Buenos Aires | C1056ABI | Argentina |
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| Centro Médico Viamonte | Not yet recruiting | Buenos Aires | C1120AAC | Argentina |
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| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada | Not yet recruiting | Buenos Aires | C1425AGC | Argentina |
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| Fundación Respirar | Not yet recruiting | Buenos Aires | C1426ABP | Argentina |
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| Centro de Investigaciones Clínicas Baigorria | Not yet recruiting | Granadero Baigorria | 2152 | Argentina |
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| Instituto Médico Río Cuarto | Not yet recruiting | Río Cuarto | X5800AEV | Argentina |
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| INECO Neurociencias Oroño | Not yet recruiting | Rosario | 2000 | Argentina |
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| Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica | Not yet recruiting | Rosario | 2000 | Argentina |
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| CIMER Centro Integral de Medicina Respiratoria | Not yet recruiting | San Miguel de Tucumán | 4000 | Argentina |
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| Centro de Salud e Investigaciones Médicas | Not yet recruiting | Santa Rosa | L6300 | Argentina |
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| Nightingale Research | Recruiting | Adelaide | 5000 | Australia |
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| Flinders University | Recruiting | Bedford Park | 5042 | Australia |
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| Box Hill Hospital | Recruiting | Box Hill | 3128 | Australia |
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| Core Research Group | Recruiting | Brisbane | 4064 | Australia |
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| Austin Health - Repatriation Hospital | Not yet recruiting | Heidelberg West | 3081 | Australia |
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| CDH Research Institute Pty Ltd | Not yet recruiting | Maroochydore | 4558 | Australia |
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| Gold Coast University Hospital | Not yet recruiting | Southport | 4215 | Australia |
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| TrialsWest - Spearwood | Recruiting | Spearwood | 6163 | Australia |
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| Instituto de Pesquisa clinica de Campinas | Not yet recruiting | Campinas | 13060-080 | Brazil |
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| Centro de Pesquisa Clínica de Marília - CPCLIM | Not yet recruiting | Marília | 17504-072 | Brazil |
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| Núcleo de Pesquisa Clínica do Rio Grande do Sul | Not yet recruiting | Porto Alegre | 90430-001 | Brazil |
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| CEMER - Centro Médico do Recife | Not yet recruiting | Recife | 51110-160 | Brazil |
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| Ruschel Medicina e Pesquisa Clínica | Not yet recruiting | Rio de Janeiro | 22270-060 | Brazil |
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| Prognosis Pesquisa Clínica | Not yet recruiting | Santo André | 09040-010 | Brazil |
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| CPHosp Medicina, Ensino e Pesquisa (CPQuali) | Not yet recruiting | São Paulo | 01228-000 | Brazil |
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| BR Trials - Ensaios Clinicos e Consultoria | Not yet recruiting | São Paulo | 01236030 | Brazil |
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| CEPIC - Centro Paulista de Investigação Clínica | Not yet recruiting | São Paulo | 04266-010 | Brazil |
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| Incor - Instituto do Coracao | Not yet recruiting | São Paulo | 05403-900 | Brazil |
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| MyCliniResearch, Inc. | Recruiting | Calgary | T2Z 3R6 | Canada |
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| Alpha Recherche Clinique - Lévis | Recruiting | Lévis | G6V 0C9 | Canada |
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| Alpha Recherche Clinique | Recruiting | Québec | G2J 0C4 | Canada |
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| C.I.C. Joliette | Not yet recruiting | Saint-Charles-Borromée | J6E 2B4 | Canada |
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| C.I.C. Saint-Laurent | Recruiting | Saint-Laurent | H4R 3C8 | Canada |
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| Maple Leaf Research | Recruiting | Toronto | M5G 1K2 | Canada |
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| C.I.C. Mauricie inc. | Recruiting | Trois-Rivières | G8T 7A1 | Canada |
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| China-Japan Friendship Hospital | Not yet recruiting | Beijing | 100029 | China |
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| The First Hospital of Jilin University | Not yet recruiting | Changchun | 130021 | China |
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| The Second Hospital of Jilin University | Not yet recruiting | Changchun | 130041 | China |
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| The Third Xiangya Hospital of Central South University | Not yet recruiting | Changsha | 410013 | China |
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| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | 610072 | China |
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| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | 400016 | China |
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| The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | Guangzhou | 510360 | China |
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| The Second People's Hospital of Hefei | Not yet recruiting | Hefei | 230011 | China |
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| The First People's Hospital of Yunnan Province | Not yet recruiting | Kunming | 650034 | China |
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| Gansu Provincial Hospital | Not yet recruiting | Lanzhou | 730000 | China |
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| The First Affiliated Hospital of Henan University of Science &Technology | Not yet recruiting | Luoyang Shi | 471003 | China |
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| The Second Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | 330006 | China |
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| Jiangxi Provincial People's Hospital | Not yet recruiting | Nanchang | 330038 | China |
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| Nanjing First Hospital | Not yet recruiting | Nanjing | 210006 | China |
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| The Second Affiliated Hospital of Guangxi Medical University | Not yet recruiting | Nanning | 053007 | China |
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| Ningbo First Hospital | Not yet recruiting | Ningbo | 315010 | China |
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| Shanghai Sixth People's Hospital | Not yet recruiting | Shanghai | 200030 | China |
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| Shanghai East Hospital | Not yet recruiting | Shanghai | 200120 | China |
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| ShenZhen People's Hospital | Not yet recruiting | Shenzhen | 518020 | China |
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| Shenzhen Hospital of Southern Medical University | Not yet recruiting | Shenzhen | 518110 | China |
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| The Second Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | 215004 | China |
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| Wuxi People's Hospital | Not yet recruiting | Wuxi | 214023 | China |
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| Xianyang Hospital of Yan'an University | Not yet recruiting | Xianyang | 712000 | China |
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| CIMS Studienzentrum Bamberg | Recruiting | Bamberg | 96049 | Germany |
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| Advanced Sleep Research | Recruiting | Berlin | 10117 | Germany |
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| InnoDiab Forschung Gmbh | Recruiting | Essen | 45136 | Germany |
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| Siteworks GmbH - Hannover | Recruiting | Hanover | 30449 | Germany |
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| Siteworks - Karlsruhe | Recruiting | Karlsruhe | 76137 | Germany |
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| Universitätsklinikum Marburg | Recruiting | Marburg | 35033 | Germany |
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| RED-Institut GmbH | Recruiting | Oldenburg | 23758 | Germany |
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| Somni bene | Recruiting | Schwerin | 19053 | Germany |
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| SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases | Not yet recruiting | Bengaluru | 560029 | India |
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| St. Johns Medical College Hospital | Not yet recruiting | Bengaluru | 560034 | India |
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| Utkal Institute of Medical Sciences and Hospital | Not yet recruiting | Bhubaneswar | 751021 | India |
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| Endolife Speciality Hospitals | Not yet recruiting | Guntur | 522001 | India |
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| KRIMS Hospital | Not yet recruiting | Nagpur | 440010 | India |
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| All India Institute of Medical Sciences | Not yet recruiting | New Delhi | 110029 | India |
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| Sir Ganga Ram Hospital | Not yet recruiting | New Delhi | 110060 | India |
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| Deenanath Mangeshkar Hospital & Research Centre | Not yet recruiting | Pune | 411004 | India |
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| All India Institute of Medical Sciences | Not yet recruiting | Raipur | 492099 | India |
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| All India Institute of Medical Sciences - Rishikesh | Not yet recruiting | Rishikesh | 249203 | India |
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| Bhakti Vedanta Hospital and Research Institute | Not yet recruiting | Thane | 401107 | India |
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| Rhythm Heart Institute - A Unit of SLPL | Not yet recruiting | Vadodara | 390022 | India |
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| Juntendo University Hospital | Recruiting | Bunkyō City | 113-8431 | Japan |
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| Fukuoka University Hospital | Recruiting | Fukuoka | 814-0180 | Japan |
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| Social Medical Corporation Sokujinkai Sleep and Mental Health Clinic - Kitahiroshima | Recruiting | Kitahiroshima | 061-1121 | Japan |
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| Kirigaokatsuda Hospital | Recruiting | Kitakyushu | 802-0052 | Japan |
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| Toranomon Hospital | Recruiting | Minatoku | 105-8470 | Japan |
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| Osaka Kaisei Hospital | Recruiting | Osaka | 532-0003 | Japan |
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| KKR Sapporo Medical Center | Recruiting | Sapporo | 062-0931 | Japan |
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| Yoyogi Sleep Disorder Center | Recruiting | Shibuya-ku | 151-0053 | Japan |
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| Nakamura Clinic | Recruiting | Urasoe | 901-2132 | Japan |
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| RESM Respiratory and Sleep Medical Care Clinic | Recruiting | Yokohama | 222-0033 | Japan |
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| Korea University Ansan Hospital | Not yet recruiting | Ansan-si | 15355 | South Korea |
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| Severance Hospital, Yonsei University Health System | Not yet recruiting | Seoul | 03722 | South Korea |
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| Asan Medical Center | Not yet recruiting | Seoul | 05505 | South Korea |
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| Korea University Guro Hospital | Not yet recruiting | Seoul | 08308 | South Korea |
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| Hospital Universitario de Guadalajara | Recruiting | Guadalajara | 19002 | Spain |
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| Hospital Universitari de Santa Maria | Recruiting | Lleida | 25198 | Spain |
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| Hospital San Pedro | Not yet recruiting | Logroño | 26006 | Spain |
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| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | 28034 | Spain |
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| Instituto de Investigaciones del Sueño | Recruiting | Madrid | 28036 | Spain |
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| Hospital Universitario La Paz | Not yet recruiting | Madrid | 28046 | Spain |
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| Hospital Universitario Virgen de la Victoria | Recruiting | Málaga | 29010 | Spain |
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| Hospital Quiron Infanta Luisa | Not yet recruiting | Seville | 41010 | Spain |
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| Hospital Universitario Virgen Del Rocio | Recruiting | Seville | 41013 | Spain |
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| China Medical University Hospital | Recruiting | Taichung | 40447 | Taiwan |
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| National Cheng-Kung Uni. Hosp. | Recruiting | Tainan | 704 | Taiwan |
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| Chang Gung Medical Foundation-Linkou Branch | Not yet recruiting | Taoyuan | 333 | Taiwan |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D009765 | Obesity |
| D050177 | Overweight |
| 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 |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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