Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-25 @ 1:38 PM
Study NCT ID:
NCT06520592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2024-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of Augmented Reality to Enhance CPAP Therapy in OSA Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participnants will be randomly assigned to experimental or control groups by using block randomized method. In the study, we will use independent staff members who are not involved in outcome assessment to handle administrative tasks related to group assignments. In order to mask outcomes assessors, we will ensure that all documents and data sets used by the outcome assessors do not contain any information that could reveal group allocation.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'For the interventional group, they will utilize AR-guided CPAP therapy to ensure a proper fit of the CPAP device mask and successful adherence to the CPAP therapy. For the standard of care group, they will receive the standard of care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2024-07-20', 'studyFirstSubmitQcDate': '2024-07-20', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The adherence of CPAP therapy', 'timeFrame': 'From enrollment to the end of treatment at 6 months', 'description': "Adherence refers to the patient's adherence to CPAP therapy, which means using CPAP for more than 70% of the total sleep time during the night, with a minimum duration of 4 hours. The calculation method involves dividing the number of days with CPAP use exceeding 4 hours by the total number of days and multiplying by 100 to obtain the average percentage of CPAP usage."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Augmented Reality (AR)', 'continuous positive airway pressure (CPAP)', 'Adherence', 'Symptoms change'], 'conditions': ['Aherence', 'Physical Symptoms', 'Mental Health', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '27542595', 'type': 'BACKGROUND', 'citation': 'Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg. 2016 Aug 19;45(1):43. doi: 10.1186/s40463-016-0156-0.'}, {'pmid': '30684472', 'type': 'BACKGROUND', 'citation': 'Bakker JP, Weaver TE, Parthasarathy S, Aloia MS. Adherence to CPAP: What Should We Be Aiming For, and How Can We Get There? Chest. 2019 Jun;155(6):1272-1287. doi: 10.1016/j.chest.2019.01.012. Epub 2019 Jan 23.'}, {'pmid': '32150700', 'type': 'BACKGROUND', 'citation': 'Wiederhold BK. How Virtual Reality Is Changing the Reality of Aging. Cyberpsychol Behav Soc Netw. 2020 Mar;23(3):141-142. doi: 10.1089/cyber.2020.29176.bkw. No abstract available.'}, {'pmid': '40327384', 'type': 'DERIVED', 'citation': 'Chen MC, Chen YC, Lin CY. Enhancing Adherence to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Using Augmented Reality: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 May 6;14:e69757. doi: 10.2196/69757.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to exam if artificial reality works to improve continuous positive airway pressure (CPAP) adherence in obstructive sleep apnea (OSA) patients. It will also learn about the feasibility of AR guided CPAP therapy. The main questions it aims to answer are:\n\nDoes AR guided CPAP therapy increase the adherence of CPAP therapy among OSA patients? What barriers do participants have when using AR guided CPAP therapy? Researchers will compare AR guided CPAP therapy to a control (standard of care) to see if AR guided CPAP therapy works to enhance the adherence of CPAP therapy.\n\nParticipants will:\n\n1. Take AR guided CPAP therapy or standard of care every day for 6 months\n2. Visit the clinic on baseline (t0), receiving CPAP therapy at the 1st month (t1), for checkups and tests, receiving CPAP therapy at the 3rd month (t2), receiving CPAP therapy at the 6th month (t3).\n3. Response their symptoms on each following time.', 'detailedDescription': 'Participants will randomly assign to two group, for experimental group will be received AR guided CPAP therapy. In the control group will be received standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) Diagnosed with moderate to severe obstructive sleep apnea (AHIā„15) through polysomnography (PSG).\n* (2) Age is equal to or greater than 20 years old or equal.\n\nExclusion Criteria:\n\n* (1) individuals who have previously used positive pressure ventilators for treatment,\n* (2) those diagnosed with central sleep apnea,\n* (3) those with uncontrolled acute mental illness,\n* (4) terminally ill patients.'}, 'identificationModule': {'nctId': 'NCT06520592', 'acronym': 'CPAP OSA', 'briefTitle': 'The Effectiveness of Augmented Reality to Enhance CPAP Therapy in OSA Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'Using Augmented Reality to Establish and Evaluate the Effectiveness of a Set of Continuous Positive Airway Pressure Care Management Protocol for Obstructive Sleep Apnea Patients', 'orgStudyIdInfo': {'id': 'A-ER-111-531'}, 'secondaryIdInfos': [{'id': '112-2628-B-110 -006 -MY3', 'type': 'OTHER_GRANT', 'domain': 'National Science and Technology Council'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'With AR guided CPAP therapy', 'description': 'OSA patientns were assigned to experimental group, they will be received AR guided CPAP therapy', 'interventionNames': ['Behavioral: With AR guided CPAP therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'OSA patientns were assigned to stand of care group, they will be not received AR guided CPAP therapy'}], 'interventions': [{'name': 'With AR guided CPAP therapy', 'type': 'BEHAVIORAL', 'description': 'Participants will received AR training course to utilize the AR guided CPAP therapy', 'armGroupLabels': ['With AR guided CPAP therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70403', 'city': 'Tainan', 'state': 'Taiwan', 'country': 'Taiwan', 'contacts': [{'name': 'Ting-Tsung Chang, MD', 'role': 'CONTACT', 'email': 'em73635@mail.hosp.ncku.edu.tw', 'phone': '886-6-2353535', 'phoneExt': '3635'}, {'name': 'Chen', 'role': 'CONTACT', 'email': 'yenchin2427@gmail.com', 'phone': '0963412677'}, {'name': 'Yen-Chin Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'centralContacts': [{'name': 'Yen Chin Chen, PhD', 'role': 'CONTACT', 'email': 'yenchin2427@gmail.com', 'phone': '886-7-5252000', 'phoneExt': '3714'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chen, Yen-Chin', 'investigatorAffiliation': 'National Sun Yat-sen University'}}}}