Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
Study NCT ID:
NCT04300166
Status:
UNKNOWN
Last Update Posted:
2020-03-09
First Post:
2020-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telemedicine and Humidification for Cpap IN Osas Key Treatment (THINK Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-06', 'studyFirstSubmitDate': '2020-03-05', 'studyFirstSubmitQcDate': '2020-03-06', 'lastUpdatePostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'CPAP efficacy: Apnea Hypopnea Index (AHI)', 'timeFrame': '6 months', 'description': 'defined as Apnea Hypopnea Index (AHI)'}, {'measure': 'Daytime somnolence', 'timeFrame': '6 months', 'description': 'Epworth Sleepiness Scale (ESS) Score'}, {'measure': 'Mask leakage', 'timeFrame': '6 months', 'description': 'L/min'}, {'measure': 'Adverse effects on CPAP', 'timeFrame': '6 months', 'description': 'List of adverse effects'}, {'measure': 'Overall Nocturnal Sleep quality', 'timeFrame': '6 months', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}], 'primaryOutcomes': [{'measure': 'CPAP usage', 'timeFrame': '1 week', 'description': 'defined as the proportion of night with CPAP usage ≥1h'}, {'measure': 'CPAP usage', 'timeFrame': '1 month', 'description': 'defined as the proportion of night with CPAP usage ≥1h'}, {'measure': 'CPAP usage', 'timeFrame': '6 months', 'description': 'defined as the proportion of night with CPAP usage ≥1h'}, {'measure': 'CPAP adherence', 'timeFrame': '1 week', 'description': 'defined as the proportion of night with CPAP usage ≥4h'}, {'measure': 'CPAP adherence', 'timeFrame': '1 month', 'description': 'defined as the proportion of night with CPAP usage ≥4h'}, {'measure': 'CPAP adherence', 'timeFrame': '6 months', 'description': 'defined as the proportion of night with CPAP usage ≥4h'}], 'secondaryOutcomes': [{'measure': 'average nightly usage of CPAP', 'timeFrame': '1 week', 'description': '(hour/night)'}, {'measure': 'average nightly usage of CPAP', 'timeFrame': '1 month', 'description': '(hour/night)'}, {'measure': 'average nightly usage of CPAP', 'timeFrame': '6 months', 'description': '(hour/night)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Telemedicine', 'CPAP'], 'conditions': ['Sleep Apnea, Obstructive', 'OSA', 'Sleep', 'Sleep Disorder', 'Hypersomnia']}, 'referencesModule': {'references': [{'pmid': '24061345', 'type': 'BACKGROUND', 'citation': 'Qaseem A, Holty JE, Owens DK, Dallas P, Starkey M, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. Management of obstructive sleep apnea in adults: A clinical practice guideline from the American College of Physicians. Ann Intern Med. 2013 Oct 1;159(7):471-83. doi: 10.7326/0003-4819-159-7-201310010-00704.'}, {'pmid': '18625666', 'type': 'BACKGROUND', 'citation': 'Dorkova Z, Petrasova D, Molcanyiova A, Popovnakova M, Tkacova R. Effects of continuous positive airway pressure on cardiovascular risk profile in patients with severe obstructive sleep apnea and metabolic syndrome. Chest. 2008 Oct;134(4):686-692. doi: 10.1378/chest.08-0556. Epub 2008 Jul 14.'}, {'pmid': '19370691', 'type': 'BACKGROUND', 'citation': 'Smith I, Nadig V, Lasserson TJ. Educational, supportive and behavioural interventions to improve usage of continuous positive airway pressure machines for adults with obstructive sleep apnoea. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007736. doi: 10.1002/14651858.CD007736.'}, {'pmid': '27018174', 'type': 'BACKGROUND', 'citation': 'Bakker JP, Wang R, Weng J, Aloia MS, Toth C, Morrical MG, Gleason KJ, Rueschman M, Dorsey C, Patel SR, Ware JH, Mittleman MA, Redline S. Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial. Chest. 2016 Aug;150(2):337-45. doi: 10.1016/j.chest.2016.03.019. Epub 2016 Mar 24.'}, {'pmid': '28858567', 'type': 'BACKGROUND', 'citation': 'Hwang D, Chang JW, Benjafield AV, Crocker ME, Kelly C, Becker KA, Kim JB, Woodrum RR, Liang J, Derose SF. Effect of Telemedicine Education and Telemonitoring on Continuous Positive Airway Pressure Adherence. The Tele-OSA Randomized Trial. Am J Respir Crit Care Med. 2018 Jan 1;197(1):117-126. doi: 10.1164/rccm.201703-0582OC.'}, {'pmid': '28926279', 'type': 'BACKGROUND', 'citation': 'Farre R, Navajas D, Montserrat JM. Is Telemedicine a Key Tool for Improving Continuous Positive Airway Pressure Adherence in Patients with Sleep Apnea? Am J Respir Crit Care Med. 2018 Jan 1;197(1):12-14. doi: 10.1164/rccm.201709-1791ED. No abstract available.'}, {'pmid': '29157591', 'type': 'BACKGROUND', 'citation': 'Hoet F, Libert W, Sanida C, Van den Broecke S, Bruyneel AV, Bruyneel M. Telemonitoring in continuous positive airway pressure-treated patients improves delay to first intervention and early compliance: a randomized trial. Sleep Med. 2017 Nov;39:77-83. doi: 10.1016/j.sleep.2017.08.016. Epub 2017 Sep 30.'}, {'pmid': '26253747', 'type': 'BACKGROUND', 'citation': 'Frasnelli M, Baty F, Niedermann J, Brutsche MH, Schoch OD. Effect of telemetric monitoring in the first 30 days of continuous positive airway pressure adaptation for obstructive sleep apnoea syndrome - a controlled pilot study. J Telemed Telecare. 2016 Jun;22(4):209-14. doi: 10.1177/1357633X15598053. Epub 2015 Aug 6.'}, {'pmid': '28621155', 'type': 'BACKGROUND', 'citation': 'Lugo V, Villanueva JA, Garmendia O, Montserrat JM. The role of telemedicine in obstructive sleep apnea management. Expert Rev Respir Med. 2017 Sep;11(9):699-709. doi: 10.1080/17476348.2017.1343147. Epub 2017 Jun 29.'}, {'pmid': '29024308', 'type': 'BACKGROUND', 'citation': 'Pepin JL, Tamisier R, Hwang D, Mereddy S, Parthasarathy S. Does remote monitoring change OSA management and CPAP adherence? Respirology. 2017 Nov;22(8):1508-1517. doi: 10.1111/resp.13183.'}, {'pmid': '31310575', 'type': 'BACKGROUND', 'citation': 'Schoch OD, Baty F, Boesch M, Benz G, Niedermann J, Brutsche MH. Telemedicine for Continuous Positive Airway Pressure in Sleep Apnea. A Randomized, Controlled Study. Ann Am Thorac Soc. 2019 Dec;16(12):1550-1557. doi: 10.1513/AnnalsATS.201901-013OC.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the study is to test the role of telemedicine combined with humidification to check CPAP treatment during the first month to improve adherence and reduce unsolved side effects of therapy.', 'detailedDescription': 'The primary goal of OSAS therapy is to obtain CPAP adaptation for the highest amount of OSAS patients to reduce the proportion of untreated OSAS in the population. This object is important considering that a longer duration of CPAP treatment is linked with better daytime functioning and metabolic and blood pressure effects of CPAP. The main endpoints will be CPAP usage (defined as the proportion of night with CPAP usage ≥1h); CPAP adherence (defined as the proportion of night with CPAP usage ≥4h); the average nightly usage of CPAP (hour/night); CPAP efficacy (defined as AHI and ESS score). Each measure will be performed after 1 week, 1 month and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: • Consecutive symptomatic OSAS patients with an AHI and an oxygen desaturation index (ODI) of \\>15/h in polysomnography (PSG) or Home Sleep Test (HST) consenting to start long term CPAP treatment.\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Unable to communicate in Italian\n* Previous usage of CPAP treatment\n* Alcohol consumption \\> 4 units \\>4 times a week\n* Acute manifestation of psychiatric diseases\n* Life expectancy of \\< 6 months for any reason\n* Surgical obesity treatment planned within the next 6 months\n* Predominantly Central sleep apnea and cheyne stokes respiration'}, 'identificationModule': {'nctId': 'NCT04300166', 'acronym': 'THINK', 'briefTitle': 'Telemedicine and Humidification for Cpap IN Osas Key Treatment (THINK Study)', 'organization': {'class': 'OTHER', 'fullName': 'Neuromed IRCCS'}, 'officialTitle': 'Effects of Telemedicine and Humidification for Continous Positive Airway Pressure (CPAP) in OSAS.', 'orgStudyIdInfo': {'id': 'ongoing'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Telemedicine & Humidification Intervention', 'description': 'In the telemedicine intervention arm, a telemetry device is instructed and attached to the CPAP. Patients are instructed to use CPAP every night. Data of the CPAP are downloaded to the internet once daily. On week days, a nurse/sleep technologist is checking the downloaded data three times per week. The contacts will be due to:\n\n1. CPAP usage \\<4h/ night for 3 consecutive night\n2. the median leakage was above 0.4 L/sec on 3 consecutive nights The nurse/sleep technologist informs the patient of the problem observed, asks for explanations and gives advice on possibilities to solve the problem. The common problems and the respective solutions (Dry mouth/throat, nasal congestion, skin irritation, conjunctivitis, headache, loss of benefits) will be discussed. The patient is encouraged to use CPAP every night. In the case of adherence \\>4h/night and acceptable leakage, a congratulatory message is sent to the patient via sms or e-mail.', 'interventionNames': ['Device: Telemedicine & Humidification']}, {'type': 'NO_INTERVENTION', 'label': 'Control without Telemedicine & humidification', 'description': 'In the control arm, no wireless telemedicine and humidifier will be used with CPAP but data stored in the CPAP machine are collected at the follow-up visit after 1 month'}], 'interventions': [{'name': 'Telemedicine & Humidification', 'type': 'DEVICE', 'description': 'Wireless control of CPAP usage, adherence, leakage and humidifier usage', 'armGroupLabels': ['Telemedicine & Humidification Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andrea Romigi, PhD', 'role': 'CONTACT', 'email': 'andrea.romigi@neuromed.it', 'phone': '+390865929636'}], 'overallOfficials': [{'name': 'Diego Centonze, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'IRCCS Neuromed'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andrea Romigi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sleep Apnoea Italian Patient Association', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Andrea Romigi', 'investigatorAffiliation': 'Neuromed IRCCS'}}}}