protocolSection identificationModule nctId: NCT06327373, orgStudyIdInfo id: Pro00114903, briefTitle: A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia, acronym: SOPHIE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia., conditionsModule conditions: Pulmonary Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Oxygen, interventions name: Room air, outcomesModule primaryOutcomes measure: Change daily hypoxemia burden, secondaryOutcomes measure: Change in six minute walk distance, secondaryOutcomes measure: Change in Montreal Cognitive Assessment (MoCA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Davita Durham East, city: Durham, state: North Carolina, zip: 27701, country: United States, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Durham Downtown, city: Durham, state: North Carolina, zip: 27703, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Research Triangle Park, city: Durham, state: North Carolina, zip: 27703, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Durham Regional, city: Durham, state: North Carolina, zip: 27704, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Durham West, city: Durham, state: North Carolina, zip: 27705, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Bull City, city: Durham, state: North Carolina, zip: 27707, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Durham Southpoint, city: Durham, state: North Carolina, zip: 27713, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Hope Valley, city: Durham, state: North Carolina, zip: 27713, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Vance County, city: Henderson, state: North Carolina, zip: 27536, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 36.32959, lon: -78.39916, locations facility: Davita Kerr Lake, city: Henderson, state: North Carolina, zip: 27537, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 36.32959, lon: -78.39916, locations facility: Davita Roxboro, city: Roxboro, state: North Carolina, zip: 27573, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 36.39375, lon: -78.98279, hasResults: False