[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07559708":3,"trial-entities:NCT07559708":85,"trial-summary:NCT07559708":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":54,"locations":57,"central_contacts":76,"overall_officials":81,"references":83,"see_also_links":84},"NCT07559708","SN-APAP-001","A Study of the Sleepnet Elara APAP Device","A Prospective, Open-label Study to Assess the Efficacy of the Elara APAP Device When Used in Patients With Obstructive Sleep Apnea","NOT_YET_RECRUITING","2026-06-30","2026-04","2026-04-30","2026-04-27","Sleepnet Corporation","INDUSTRY",false,"The goal of this study is to evaluate the effectiveness of the Elara APAP device.","A prospective open label study to assess the efficacy of the Elara APAP device when used in patients with obstructive sleep apnea. Subjects will sign Informed Consent and undergo screening\u002Fbaseline and a 1 night in-lab PSG.",[19],"Sleep Apnea - Obstructive",[21,22,23,24,25,26],"OSA","Sleep Apnea","APAP","Polysomnography","Obstructive Sleep Apnea","Sleep Study","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},55,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DEVICE","Sleepnet Elara Treatment","Subject to have a 1 night in-lab PSG",[40],"Treatment",[42],{"measure":43,"description":44,"timeFrame":45},"AHI 4%","The primary endpoint of this study is treatment night AHI 4%. A subject is considered a success if the Apnea Hypopnea Index calculated by using hypopneas that cause a 4% or greater drop in blood oxygen levels per hour of sleep (AHI4) measured during the 1-night treatment study (PSG) is less than 10 events\u002Fhour or less than 10% of the baseline AHI4 value determined at previous diagnosis, whichever is greater.","Day 1",[],"ALL","18 Years",null,{"inclusion":51,"exclusion":52,"raw_text":53},[],[],"Inclusion Criteria:\n\n1. Body weight ≥ 30kg\n2. Willing and able to consent, adhere to study requirements and receive mask treatment\n3. ≥ 18 years of age\n4. Diagnosed with OSA (Total AHI \\>15 events\u002Fhr) by a practicing physician within the last 6 months. A re-diagnosis may be necessary to establish current baseline AHI in case there has been significant weight change or other co-morbidities since the previous diagnosis (per PI discretion)\n5. Currently utilizing an APAP Device for ongoing treatment of OSA\n\nExclusion Criteria:\n\n1. Body weight \\\u003C 30kg\n2. Female currently bearing a child or intending to become pregnant prior to the sleep study.\n3. Have implanted pacemaker, ICD or any other medical device that would interfere with the PSG results or safety of the subject undergoing the study\n4. Has pneumothorax, pneumomediastinum\n5. Has history of Cerebrospinal fluid leakage, craniocerebral trauma, intracranial trauma or pneumocephalus\n6. Ongoing shock from various causes untreated\n7. Current epistaxis\n8. Non-compliant with APAP usage (\\\u003C 4 hours per night on 70% of nights)\n9. Upper gastrointestinal bleeding that has not been effectively controlled\n10. Has obstructive vocal cord polyps\n11. Severe coronary heart disease with left heart failure\n12. Acute otitis media inflammation (must be resolved prior to sleep study)\n13. Excessive respiratory secretions and cough weakness\n14. Weak spontaneous breathing\n15. Tracheal intubation (nasal or oral) and tracheotomy\n16. Severe nasal congestion from various causes\n17. Lung bullae\n18. Central sleep apnea index \\>5 events\u002Fhr\n19. Have another significant sleep disorder(s) that in the opinion of the investigator would confound the results of the study (e.g. periodic leg movements \\>15\u002Fhr or insomnia that would interfere with completing the sleep study).",[55,56],"ADULT","OLDER_ADULT",[58],{"facility":59,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":73},"University Sleep Disorders Center","Auburn","Alabama","36832","United States",[65,70],{"name":66,"role":67,"phone":68,"email":69},"Jessica Grossmann","CONTACT","205-643-2401","jgrossmann@medocationresearch.com",{"name":71,"role":72},"Anthony McLeod, MD","PRINCIPAL_INVESTIGATOR",{"lat":74,"lon":75},32.60986,-85.48078,[77],{"name":78,"role":67,"phone":79,"email":80},"Andrea Brown, M.S.","408-881-2611","abrown@abioclinical.com",[82],{"name":71,"affiliation":59,"role":72},[],[],{"nct_id":4,"conditions":86,"biomarkers":87},[25],[],{"nct_id":4,"found":89,"summary":90,"prompt_version":100},true,{"design":91,"status":92,"heading":93,"summary":94,"follow_up":95,"word_count":96,"commitments":97,"compensation":98,"drugs_mentioned":99},"This is an open-label study, meaning both you and the study team will know you are receiving the Sleepnet Elara treatment. It plans to include 55 participants.","completed","Study of the Sleepnet Elara APAP Device for Obstructive Sleep Apnea","This study is testing the Sleepnet Elara APAP device to see how well it works for people with obstructive sleep apnea (OSA). OSA is a condition where breathing repeatedly stops and starts during sleep. To join, you must be at least 18 years old, weigh 30kg (about 66 pounds) or more, and have been diagnosed with OSA (meaning you have more than 15 breathing interruptions per hour during sleep). The study will measure how much the Sleepnet Elara device reduces these breathing interruptions. The current recruitment status is unclear.","Your breathing interruptions will be measured on Day 1 after treatment.",89,"You will sign a consent form, go through screening, and have one night of in-lab PSG (polysomnography), which is a sleep study.","Not stated in the trial record.",[],"v2"]