[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05429983":3,"trial-entities:NCT05429983":88,"trial-summary:NCT05429983":92},{"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":21,"primary_purpose":17,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":27,"secondary_outcomes":36,"sex":44,"minimum_age":45,"maximum_age":17,"healthy_volunteers":17,"eligibility_criteria":46,"std_ages":58,"locations":61,"central_contacts":77,"overall_officials":82,"references":86,"see_also_links":87},"NCT05429983","IRB00319723","Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy With Stimulated Upper Airway Mechanics","Assessing Stimulated Upper Airway Mechanics to Predict Outcomes in Hypoglossal Nerve","RECRUITING","2028-11-29","2025-12","2025-12-24","2022-11-29","Johns Hopkins University","OTHER",false,"Obstructive sleep apnea (OSA) is a highly prevalent disease resulting from dynamic upper airway collapse during sleep. Continuous positive airway pressure (CPAP) is highly efficacious but high rates of non-adherence to CPAP leaves large number of OSA patients at risk for cardiometabolic sequelae. Inspire™ is an FDA-approved hypoglossal nerve stimulation device (HGNS) used in select patients with OSA who are intolerant of CPAP. The device consists of an implanted impulse generator with a stimulating cuff lead around the distal hypoglossal nerve. Despite these stringent selection criteria, up to one-third of patients implanted have inadequate responses to HGNS and remain at risk for complications from untreated OSA. The current proposal builds on routine clinical care to characterize upper airway biomechanics and determine predictors of clinical responses to HGNS therapy.\n\nDrug induced sleep endoscopy (DISE) is a prerequisite for HGNS treatment and represents an ideal opportunity to rapidly characterize upper airway dynamics under controlled, standardized conditions. The amount of nasal pressure required to relieve airway obstruction (minimal therapeutic pressure) is a significant predictor of successful treatment of OSA with HGNS. As a result, CPAP titration (measuring pharyngeal collapse patterns at varying nasal pressures) has become an integral part of DISE to select parties for HGNS at multiple institutions. Nevertheless, changes in upper airway collapsibility in response HGNS may differ significantly between patients. This stud will examine if changes in upper airway patency with direct genioglossus muscle stimulation at the time of DISE predicts successful treatment with HGNS as defined by a 50% reduction on apnea-hypopnea index (AHI) and an on-treatment AHI \\\u003C20.",null,[19],"Sleep Apnea, Obstructive",[],"OBSERVATIONAL",[],{"count":24,"type":25},60,"ESTIMATED",[],[28,32],{"measure":29,"description":30,"timeFrame":31},"Tidal airflow with direct genioglossus stimulation","Tidal airflow (mL) with direct stimulation of the genioglossus muscle will be measured at the time of drug-induced sleep endoscopy.","at the time of drug-induced sleep endoscopy, up to 1 hour",{"measure":33,"description":34,"timeFrame":35},"HGNS therapy success as assessed by the apnea hypopnea index","Successful treatment with HGNS, as defined by a 50% reduction in apnea hypopnea index (AHI) and an on-therapy AHI of \\\u003C15 (the same criteria as in major trials of non-CPAP OSA treatment).","at 1 year post HGNS implantation",[37,41],{"measure":38,"description":39,"timeFrame":40},"Therapeutic CPAP pressure with direct genioglossus stimulation","Therapeutic CPAP pressure (cmH20) with direct stimulation of the genioglossus muscle will be measured at the time of drug-induced sleep endoscopy.","At the time of drug-induced sleep endoscopy, up to 1 hour",{"measure":42,"description":43,"timeFrame":40},"Airway critical closing pressure with direct genioglossus stimulation","Airway critical closing pressure (cmH20) with direct stimulation of the genioglossus muscle will be measured at the time of drug-induced sleep endoscopy.","ALL","18 Years",{"inclusion":47,"exclusion":49,"raw_text":57},[48],"Male and female participants with moderate or severe sleep apnea (defined by \\> 15 apneas and hypopneas per hour of sleep), who are undergoing DISE as part of routine evaluation for Inspire hypoglossal nerve stimulation therapy or for ineffective HGNS therapy.",[50,51,52,53,54,55,56],"Significant cardiac disease, unstable or recent cardiac events","Active pulmonary, liver or renal disease","Uncontrolled hypertension (BP\\>160\u002F100)","Neuromuscular disease","Major psychiatric disease","Pregnancy","Anticoagulation therapy (e.g. Coumadin, Dabigatran)","Inclusion Criteria:\n\n* Male and female participants with moderate or severe sleep apnea (defined by \\> 15 apneas and hypopneas per hour of sleep), who are undergoing DISE as part of routine evaluation for Inspire hypoglossal nerve stimulation therapy or for ineffective HGNS therapy.\n\nExclusion Criteria:\n\n* Significant cardiac disease, unstable or recent cardiac events\n* Active pulmonary, liver or renal disease\n* Uncontrolled hypertension (BP\\>160\u002F100)\n* Neuromuscular disease\n* Major psychiatric disease\n* Pregnancy\n* Anticoagulation therapy (e.g. Coumadin, Dabigatran)",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":63,"status":8,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":74},"Johns Hopkins Hospital","Baltimore","Maryland","21287","United States",[69],{"name":70,"role":71,"phone":72,"email":73},"Kevin M Motz, MD","CONTACT","301-992-1779","kmotz1@jhmi.edu",{"lat":75,"lon":76},39.29038,-76.61219,[78],{"name":79,"role":71,"phone":80,"email":81},"Kevin M Motz","410614245","kmotz1@jh.edu",[83],{"name":84,"affiliation":13,"role":85},"Kevin Motz, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":89,"biomarkers":91},[90],"Obstructive Sleep Apnea",[],{"nct_id":4,"found":93,"summary":94,"prompt_version":104},true,{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an observational study, meaning researchers will watch and record information without giving you a specific treatment. It plans to include 60 participants.","completed","Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy for Sleep Apnea","This observational study is looking at ways to better predict who will benefit from Inspire™ hypoglossal nerve stimulation (HGNS) therapy for obstructive sleep apnea (OSA). Inspire™ is an FDA-approved device for people with OSA who can't use CPAP. Currently, about one-third of patients don't respond well to HGNS. Researchers will measure airflow during a procedure called drug-induced sleep endoscopy (DISE) to see if it can help predict success. You may be able to join if you are an adult with moderate or severe sleep apnea and are having a DISE for HGNS evaluation or if your current HGNS therapy isn't working. The study aims to see if these airflow measurements can predict HGNS success one year after the device is implanted. The study status is unclear.","Participants will be followed for one year after HGNS implantation to assess therapy success.",126,"Participants will have their tidal airflow measured during a drug-induced sleep endoscopy (DISE) procedure, which takes up to one hour. Success of HGNS therapy will be assessed one year after implantation.","Not stated in the trial record.",[],"v2"]