[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07714330":3,"trial-entities:NCT07714330":114,"trial-summary:NCT07714330":118},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":40,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":77,"locations":80,"central_contacts":98,"overall_officials":106,"references":112,"see_also_links":113},"NCT07714330","CIP-001","Effectiveness of Audio Cues to Achieve Positional Therapy in Patients With Positional Obstructive Sleep Apnea","Effectiveness of WhisperPT's Audio Cues to Achieve Positional Therapy in Patients With Positional Obstructive Sleep Apnea","RECRUITING","2026-12-30","2026-07","2026-07-21","2026-06-25","SleepDev, Inc","INDUSTRY",false,"Patients with obstructive sleep apnea (OSA) often experience more frequent and severe breathing disturbances when sleeping in the supine (back-sleeping) position compared with non-supine positions. Positional therapy aims to reduce time spent sleeping in the supine position, but existing treatment options may be limited by comfort and effectiveness. This study evaluates the effectiveness and usability of WhisperPT, an investigational in-ear positional therapy device that delivers gentle audio cues during sleep to encourage participants to move from the supine to a non-supine sleeping position. The study will assess the device's ability to reduce the apnea-hypopnea index (AHI), decrease time spent sleeping supine, and evaluate participant comfort and ease of use.",null,[19,20],"Obstructive Sleep Apnea (OSA)","Positional Obstructive Sleep Apnea",[20],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},30,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Investigational Positional Therapy Device","The investigational intervention is a non-invasive, investigational in-ear positional therapy device worn in the ear during sleep. The device continuously monitors head position and delivers gentle audio cues when the participant remains in the supine (back-sleeping) position to encourage a return to a non-supine sleeping position. The device is evaluated as part of a structured protocol including baseline assessment, acclimation, and treatment nights.",[32],[36],{"measure":37,"description":38,"timeFrame":39},"Participants Achieving ≥50% Reduction in AHI","Proportion of participants achieving a minimum 50% reduction in apnea-hypopnea index (AHI) during treatment compared with baseline, untreated AHI as measured by the WatchPAT ONE home sleep test.","Intervention assessment (Night 5), within approximately 7 days",[41,44],{"measure":42,"description":43,"timeFrame":39},"Proportion of participants with supine sleep percentage of less than 15%","Proportion of participants with less than 15% of total sleep time spent in the supine position during the intervention assessment, as measured by the WatchPAT ONE home sleep test.",{"measure":45,"description":46,"timeFrame":47},"Self-reported Comfort, Overnight Retention, and Ease of Device Use","Participant-reported comfort while wearing the investigational device, overnight device retention, and ease of device use, assessed using the study exit questionnaire.","Study completion (approximately 7 days)","ALL","18 Years","75 Years",{"inclusion":52,"exclusion":62,"raw_text":76},[53,54,55,56,57,58,59,60,61],"Diagnosing sleep study identified a significant positional component to their obstructive sleep apnea (OSA) diagnosis as measured by at least a 50% reduction in Apnea-Hypopnea Index (AHI) while sleeping non-supine compared to supine","Diagnosing sleep study included at least 40% of the night recorded in supine and at least 20% of the night in non-supine position","Have an overall AHI \\> 10 (4% desaturation)","Diagnosing sleep study included a minimum of 5 hours total sleep time (TST)","Willing to abstain from use of any other treatments for sleep-disordered breathing beginning at least 3 days prior to at-home study testing and for the remaining duration of their study participation","Between ages 18-75","Must be able to refrain from alcohol use during nights of at-home study testing","Speaks and reads English sufficiently to understand the study informed consent, study instructions, and study materials","Signs study-specific informed consent form",[63,64,65,66,67,68,69,70,71,72,73,74,75],"Active medical conditions that would prevent study participation as determined by the principal investigator, including: Inability to easily move from between back and side in both directions Inability to sleep in lateral or supine position due to injury or a medical condition OR inability to sleep in a non-elevated\u002F tilted bed","Requiring medications to sleep","Prior diagnosis of a significant other sleep disorder such as restless leg syndrome\u002Fperiodic limb movement disorder, primary central sleep apnea, pronounced insomnia, parasomnias, central disorder of hypersomnolence, etc","An active ear infection OR an ear infection within the past month OR a history of \\>3 ear infections per year","Unusual outer ear, including enlarged or extra small anatomy, that prevents device use","Significant hearing impairment or ear skin issues, including:","Suffering from tinnitus","BMI \\>35","Current use of any illegal drugs.","Currently pregnant or currently lactating","Current enrollment in a clinical study of any other unapproved investigational drug or device.","Inability or unwillingness to comply with the study requirements.","Any other condition or laboratory value that could, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the participant.","Inclusion Criteria:\n\n* Diagnosing sleep study identified a significant positional component to their obstructive sleep apnea (OSA) diagnosis as measured by at least a 50% reduction in Apnea-Hypopnea Index (AHI) while sleeping non-supine compared to supine\n* Diagnosing sleep study included at least 40% of the night recorded in supine and at least 20% of the night in non-supine position\n* Have an overall AHI \\> 10 (4% desaturation)\n* Diagnosing sleep study included a minimum of 5 hours total sleep time (TST)\n* Willing to abstain from use of any other treatments for sleep-disordered breathing beginning at least 3 days prior to at-home study testing and for the remaining duration of their study participation\n* Between ages 18-75\n* Must be able to refrain from alcohol use during nights of at-home study testing\n* Speaks and reads English sufficiently to understand the study informed consent, study instructions, and study materials\n* Signs study-specific informed consent form\n\nExclusion Criteria:\n\n-Active medical conditions that would prevent study participation as determined by the principal investigator, including: Inability to easily move from between back and side in both directions Inability to sleep in lateral or supine position due to injury or a medical condition OR inability to sleep in a non-elevated\u002F tilted bed\n\n* Requiring medications to sleep\n* Prior diagnosis of a significant other sleep disorder such as restless leg syndrome\u002Fperiodic limb movement disorder, primary central sleep apnea, pronounced insomnia, parasomnias, central disorder of hypersomnolence, etc\n* An active ear infection OR an ear infection within the past month OR a history of \\>3 ear infections per year\n* Unusual outer ear, including enlarged or extra small anatomy, that prevents device use\n* Significant hearing impairment or ear skin issues, including:\n\nParticipants with cochlear implants or those who will be affected by small magnets in the ear\n\n* Suffering from tinnitus\n* BMI \\>35\n* Current use of any illegal drugs.\n* Currently pregnant or currently lactating\n* Current enrollment in a clinical study of any other unapproved investigational drug or device.\n* Inability or unwillingness to comply with the study requirements.\n* Any other condition or laboratory value that could, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the participant.",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":95},"Peninsula Sleep Center","Burlingame","California","94010","United States",[88,93],{"name":89,"role":90,"phone":91,"email":92},"Mehran Farid, M.D.","CONTACT","650-779 4055","mehran@peninsulasleep.com",{"name":89,"role":94},"PRINCIPAL_INVESTIGATOR",{"lat":96,"lon":97},37.5841,-122.36608,[99,103],{"name":100,"role":90,"phone":101,"email":102},"Michael Swertfager","408-499-6884","mswertfager@sleepdev.com",{"name":104,"role":90,"email":105},"Joshua Roland, M.D.","jrolandsleep@gmail.com",[107,109,111],{"name":100,"affiliation":13,"role":108},"STUDY_CHAIR",{"name":104,"affiliation":13,"role":110},"STUDY_DIRECTOR",{"name":89,"role":94},[],[],{"nct_id":4,"conditions":115,"biomarkers":117},[116],"Obstructive Sleep Apnea",[],{"nct_id":4,"found":119,"summary":120,"prompt_version":130},true,{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This interventional study plans to enroll 30 participants. It is not specified if it is randomized or blinded.","completed","Effectiveness of Audio Cues for Positional Obstructive Sleep Apnea","This study is testing an investigational in-ear device called WhisperPT for people with positional obstructive sleep apnea (OSA). If you have OSA, you might experience more breathing problems when sleeping on your back. This device aims to help you sleep in other positions by giving gentle audio cues. Researchers want to see if WhisperPT can reduce your Apnea-Hypopnea Index (AHI), which measures breathing disturbances during sleep, and how comfortable and easy it is to use. To join, you must be 18-75 years old and have a sleep study showing your OSA is significantly worse when sleeping on your back. The study plans to enroll 30 participants, but its current status is unclear.","The primary outcome is measured at Intervention assessment (Night 5), within approximately 7 days.",112,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]