Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-03-04 @ 10:07 PM
Study NCT ID:
NCT03047720
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2016-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Scheduled Awakenings for the Treatment of Nocturnal Enuresis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053206', 'term': 'Nocturnal Enuresis'}], 'ancestors': [{'id': 'D004775', 'term': 'Enuresis'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bwhittam@iupui.edu', 'phone': '317.944.8896', 'title': 'Dr Benjamin Whittam', 'organization': 'Indiana University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study N too small to perform statistical analysis. Limits included decreased bedwetting during baseline, inconsistent user data entry in app, app glitches, lack of participant interest in proceeding to S2 after completing S1. Study ended early.'}}, 'adverseEventsModule': {'timeFrame': '6weeks', 'description': 'The number of participants in ARM 2 at risk all-cause mortality, SAEs, and other adverse events was zero because no patients advanced to that arm.', 'eventGroups': [{'id': 'EG000', 'title': 'S1: Lully Device Plus Behavioral Modifications', 'description': 'The S1 therapeutic phase of this study was: 6 weeks of behavioral modifications plus the Lully device\n\nThe family received counseling on behavioral modifications during initial baseline phase to follow throughout S1.\n\nDuring this phase, a scheduled awakening was performed each night with the Lully pod following the scheduled awakening protocol using Lully Sleep Guardian. This was used to reliably produce a brief awakening by titrating the device to a minimal awakening stimulus during the first night of use. If the brief awakening could not be produced using the Lully pod, the parent was to gently awaken the child\n\nParticipants were asked to enter responses daily into a Lully Study app. The questions the participant was prompted to answer were to serve to document occurrence of bedwetting and the degree of wetness.\n\nIn addition, the family were asked to complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'S2: Behavioral Modifications Only', 'description': 'The S2 therapeutic phase of this study : 6 weeks of behavioral modifications only without the device.\n\nThe family received counseling on behavioral modifications during initial baseline phase to follow throughout S1.\n\nDuring this phase, participants were asked to enter responses daily into a Lully Study app. The questions the participant was prompted to answer were to serve to document occurrence of bedwetting and the degree of wetness.\n\nIn addition, the family were asked to complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Number of Dry Nights When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lully Device', 'description': 'Participants who completed 6 weeks of behavioral modifications plus the Lully device'}, {'id': 'OG001', 'title': 'No Device', 'description': 'Participants who completed 6 weeks of behavioral modifications only without the device'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 weeks (end of S1)', 'description': 'Participants were asked to enter responses daily into a Lully Study app.The questions the participant was prompted to answer: Did your child have a bed wetting episode last night? Answered by yes or no.', 'unitOfMeasure': 'difference in number of dry nights', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed at least 37 nights of data entry using the scheduled awakening protocol with the Lully Sleep Guardian'}, {'type': 'PRIMARY', 'title': 'Change in Number of Voids Per Night When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lully Device', 'description': 'Participants who completed 6 weeks of behavioral modifications plus the Lully device'}, {'id': 'OG001', 'title': 'No Device', 'description': 'Participants who completed 6 weeks of behavioral modifications only without the device'}], 'timeFrame': 'Not measured.', 'description': 'Participants were asked to enter responses daily into a Lully Study app.The questions the participant was prompted to answer: Did your child have a bed wetting episode last night? (Answered by yes or no) What time?', 'reportingStatus': 'POSTED', 'populationDescription': 'Unable to measure because data was not collected.'}, {'type': 'PRIMARY', 'title': 'Change in Quantity of Wetness When Bedwetting Occurred While Using the Scheduled Awakening Protocol With the Lully', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lully Device', 'description': 'Participants who completed 6 weeks of behavioral modifications plus the Lully device'}, {'id': 'OG001', 'title': 'No Device', 'description': 'Participants who completed 6 weeks of behavioral modifications only without the device'}], 'timeFrame': 'Not measured.', 'description': 'Participants were asked to enter responses daily into a Lully Study app. In a free text box the family was asked to add additional information to describe how wet the child was using the following 1-5 scale: 1- wet underwear; 2-wet underwear and damp pajamas; 3- soaked underwear, pajamas; 4-soaked pajamas, damp mattress; 5- soaked mattress.', 'reportingStatus': 'POSTED', 'populationDescription': 'No participant were analyzed. Data was not available. Contributors: data not entered by participants and app glitches could have lead to lost data if entered'}, {'type': 'PRIMARY', 'title': 'QOL Measures Using the KIDS Screen Questionnaire at 10 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lully Device', 'description': 'Participants who completed 6 weeks of behavioral modifications plus the Lully device'}, {'id': 'OG001', 'title': 'No Device', 'description': 'Participants who completed 6 weeks of behavioral modifications only without the device'}], 'classes': [{'categories': [{'measurements': [{'value': '42.75', 'spread': '5.97', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': 'Participants were asked to complete QOL survey (KIDSCREEN 27) at baseline, before starting therapeutic phase, and after completing therapeutic phase. KIDSCREEN is a standardized questionnaire for children and adolescents to assess their health related quality of life (HRQoL). Each items scored on a 5-point scale. There is the KIDSCREEN 54 (long version) KIDSCREEN 27 (short version) KIDSCREEN 10 Index. For analysis, decision made to analyze questions in the KIDSCREEN 10 Index questions only. For KIDSCREEN 10, it is a 5 point Likert Scale with a score range of 10 to 50 with higher scores indicating better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients analyzed completed the KIDSCREEN after completing the 6 weeks use of the Lully device. 4 of 5 who completed the 6 weeks use the Lully device completed the KIDSCREEN. Data was not collected for Baseline and 4 wk scores.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lully Device First, Then No Device', 'description': 'Lully device plus Behavioral modifications plus for daily for 6 weeks (S1), followed behavioral modifications only without the device daily for 6week (S2)\n\nNo washout period between S1 and S2 because there was no carryover effect from either intervention'}, {'id': 'FG001', 'title': 'No Device First, Then Lully Device', 'description': 'Behavioral modifications only without the device (S2) daily for 6weeks, followed by of behavioral modifications plus use of the Lully device daily for 6 weeks(S1)\n\nNo washout period between S2 and S1 because there was no carryover effect from either intervention'}], 'periods': [{'title': 'First Intervention (6weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Participant data entry insufficient', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (6weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lully Device First, Then No Device', 'description': 'Lully device plus Behavioral modifications plus for daily for 6 weeks (S1), followed behavioral modifications only without the device daily for 6week (S2)\n\nNo washout period between S1 and S2 because there was no carryover effect from either intervention'}, {'id': 'BG001', 'title': 'No Device First, Then Lully Device', 'description': 'Behavioral modifications only without the device (S2) daily for 6weeks, followed by of behavioral modifications plus use of the Lully device daily for 6 weeks(S1)\n\nNo washout period between S2 and S1 because there was no carryover effect from either intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Vancouver Questionnaire Score', 'classes': [{'categories': [{'measurements': [{'value': '9.28', 'spread': '3.10', 'groupId': 'BG000'}, {'value': '9.28', 'spread': '3.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Vancouver is a 14 item questionnaire for diagnosing Dysfunctional Elimination Syndrome (DES). There is a 5-point Likert scale used for all questions. Item score range from 0 (no complaint) to 4 (severe symptoms). Question 1-13 probe for a single symptom. Question 14 speaks to ease of completing the questions. For this study, subjects with a Vancouver score less \\< or = to 11 (for questions 1-13) met the criteria for benign nocturnal enuresis and were determined eligible to participate. Score \\> 11 met criteria for DES. Total score range (for 1-13): min score of 0 to max of 52.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Participants did not show continued desire to document daily data after ending study phase one and discontinuing use of the Lully device'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2017-02-20', 'size': 177768, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-06-24T15:47', 'hasProtocol': False}, {'date': '2018-06-15', 'size': 309253, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-08-11T10:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-26', 'studyFirstSubmitDate': '2016-12-28', 'resultsFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2017-02-06', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-24', 'studyFirstPostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Number of Dry Nights When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian', 'timeFrame': 'baseline and 6 weeks (end of S1)', 'description': 'Participants were asked to enter responses daily into a Lully Study app.The questions the participant was prompted to answer: Did your child have a bed wetting episode last night? Answered by yes or no.'}, {'measure': 'Change in Number of Voids Per Night When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian', 'timeFrame': 'Not measured.', 'description': 'Participants were asked to enter responses daily into a Lully Study app.The questions the participant was prompted to answer: Did your child have a bed wetting episode last night? (Answered by yes or no) What time?'}, {'measure': 'Change in Quantity of Wetness When Bedwetting Occurred While Using the Scheduled Awakening Protocol With the Lully', 'timeFrame': 'Not measured.', 'description': 'Participants were asked to enter responses daily into a Lully Study app. In a free text box the family was asked to add additional information to describe how wet the child was using the following 1-5 scale: 1- wet underwear; 2-wet underwear and damp pajamas; 3- soaked underwear, pajamas; 4-soaked pajamas, damp mattress; 5- soaked mattress.'}, {'measure': 'QOL Measures Using the KIDS Screen Questionnaire at 10 Weeks', 'timeFrame': '10 weeks', 'description': 'Participants were asked to complete QOL survey (KIDSCREEN 27) at baseline, before starting therapeutic phase, and after completing therapeutic phase. KIDSCREEN is a standardized questionnaire for children and adolescents to assess their health related quality of life (HRQoL). Each items scored on a 5-point scale. There is the KIDSCREEN 54 (long version) KIDSCREEN 27 (short version) KIDSCREEN 10 Index. For analysis, decision made to analyze questions in the KIDSCREEN 10 Index questions only. For KIDSCREEN 10, it is a 5 point Likert Scale with a score range of 10 to 50 with higher scores indicating better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['bedwetting'], 'conditions': ['Nocturnal Enuresis']}, 'referencesModule': {'references': [{'pmid': '22031959', 'type': 'BACKGROUND', 'citation': 'National Clinical Guideline Centre (UK). Nocturnal Enuresis: The Management of Bedwetting in Children and Young People. London: Royal College of Physicians (UK); 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK62712/'}, {'pmid': '24255762', 'type': 'BACKGROUND', 'citation': 'Ahmed AF, Amin MM, Ali MM, Shalaby EA. Efficacy of an enuresis alarm, desmopressin, and combination therapy in the treatment of saudi children with primary monosymptomatic nocturnal enuresis. Korean J Urol. 2013 Nov;54(11):783-90. doi: 10.4111/kju.2013.54.11.783. Epub 2013 Nov 6.'}, {'pmid': '12804443', 'type': 'BACKGROUND', 'citation': 'Glazener CM, Evans JH, Peto RE. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2003;(2):CD002911. doi: 10.1002/14651858.CD002911.'}, {'pmid': '25086164', 'type': 'BACKGROUND', 'citation': 'Bayne AP, Skoog SJ. Nocturnal enuresis: an approach to assessment and treatment. Pediatr Rev. 2014 Aug;35(8):327-34; quiz 335. doi: 10.1542/pir.35-8-327.'}, {'pmid': '7609169', 'type': 'BACKGROUND', 'citation': 'Monda JM, Husmann DA. Primary nocturnal enuresis: a comparison among observation, imipramine, desmopressin acetate and bed-wetting alarm systems. J Urol. 1995 Aug;154(2 Pt 2):745-8.'}, {'pmid': '25158273', 'type': 'BACKGROUND', 'citation': 'Onol FF, Guzel R, Tahra A, Kaya C, Boylu U. Comparison of long-term efficacy of desmopressin lyophilisate and enuretic alarm for monosymptomatic enuresis and assessment of predictive factors for success: a randomized prospective trial. J Urol. 2015 Feb;193(2):655-61. doi: 10.1016/j.juro.2014.08.088. Epub 2014 Aug 23.'}, {'type': 'BACKGROUND', 'citation': '7.Rink A. Lully Sleep Guardian. In: Heinsimer K, editor. IU Health2016.'}, {'type': 'BACKGROUND', 'citation': '8. Lully Sleep Guardian - Proven to Stop Night Terrors: Amazon; 2016 [cited 2015 2016]. Available from: http://www.amazon.com/Lully-Sleep-Guardian-Proven-Terrors/dp/B011LOUNCI/ref=sr_1_1?ie=UTF8&qid=1457660065&sr=8-1-spons&keywords=lully+sleep+guardian&psc=1#customerReviews.'}]}, 'descriptionModule': {'briefSummary': 'This study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any effect on benign nocturnal enuresis.', 'detailedDescription': "Primary monosymptomatic nocturnal enuresis (PMNE) is defined by the Diagnostic \\& Statistical Manual of Mental Disorders (DSM- IV) as an involuntary voiding of urine during sleep, with a severity of at least twice a week, in children aged \\>5 years in the absence of congenital or acquired defects of the central nervous system(1-3).\n\nPMNE affects 10-20% kids at 5 years old (1, 4, 5). It does resolve spontaneously so that 5% of 10 year olds and 1% of 15 year olds are still affected (2-4). Is more common in boys. While the disease its self is benign, and improves without intervention, it does pose a significant social and emotional burden on the child and their family. These include parental disapproval, sibling teasing, and inability to attend sleep overs with peers, all of which lead to families seeking treatment options (3, 4).\n\nCurrent treatments start with conservative management. This includes appropriate fluid intake, scheduled toileting during the day, avoidance of bladder irritants and constipation (4, 5). If these fail to improve symptoms or families are looking for a more active form of treatment, first line therapy is either a bed wetting alarms or desmopressin (1, 4, 5).\n\nThe Lully Sleep Guardian was initially developed for use in night terrors. The device works by programing a vibrating disk that is placed under the child's bed to alter sleep patterns and prevent the onset of sleep terrors. The child is not woken up for the treatment of sleep terrors. The device has also been shown to anecdotally improve users' nocturnal enuresis. There have been no reports of safety concerns or hazards with the device (7, 8).\n\nThe aim of this study is to determine the effectiveness of scheduled awakenings, with the Lully Sleep Guardian, in patients with PMNE, at reducing the frequency of bed-wetting."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Benign nocturnal enuresis\n* Age: 5 - 17\n* Must have or have access to an Apple iPhone, iPad, or iPod Touch\n\nExclusion Criteria:\n\n* Diurnal Enuresis\n* Constipation\n* Neurogenic Bladder\n* Any serious underlying cardiopulmonary problems that require diuretics or antihypertensive medications to manage\n* Any bladder active medications\n* Age: \\< 5 years of age; \\> 17 years of age\n* Cerebral Palsy\n* Mental disorders, mood disorders, or autism-spectrum disorder\n* Epilepsy or seizure history\n* Restless leg syndrome\n* Use of benzodiazepine/clonidine'}, 'identificationModule': {'nctId': 'NCT03047720', 'briefTitle': 'Scheduled Awakenings for the Treatment of Nocturnal Enuresis', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Scheduled Awakenings for the Treatment of Nocturnal Enuresis', 'orgStudyIdInfo': {'id': '1601620278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'One: Study Phases (S1 and S2)', 'description': 'The therapeutic phase of this study for the participant in Arm One will be: 6 weeks of behavioral modifications plus the Lully device (S1), followed by 6 weeks of behavioral modifications only without the device (S2)', 'interventionNames': ['Device: Lully Sleep Guardian']}, {'type': 'OTHER', 'label': 'Two: Study Phases (S2 and S1)', 'description': 'The therapeutic phase of this study for the participant in Arm Two will be: 6 weeks of behavioral modifications only without the device (S2), followed by 6 weeks of behavioral modifications plus use of the Lully device(S1)', 'interventionNames': ['Device: Lully Sleep Guardian']}], 'interventions': [{'name': 'Lully Sleep Guardian', 'type': 'DEVICE', 'description': 'In the initial phase, participant baseline is established. In the Therapeutic Phase, each participant will complete the study phases (S1 and S2) in the order determined by their assigned treatment arm. During the scheduled awakening protocol using Lully Sleep Guardian, a scheduled awakening will be performed each night with the Lully pod.\n\nDuring the initial and therapeutic phases of this study, participants are asked to enter responses daily into a Lully Study app. The app will send a prompt each morning. The questions the participant is prompted to answer serve to document occurrence of bedwetting and the degree of wetness.\n\nIn addition, the family will complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals throughout the study.', 'armGroupLabels': ['One: Study Phases (S1 and S2)']}, {'name': 'Lully Sleep Guardian', 'type': 'DEVICE', 'description': 'In the initial phase, participant baseline is established. In the Therapeutic Phase, each participant will complete the study phases (S1 and S2) in the order determined by their assigned treatment arm. During the scheduled awakening protocol using Lully Sleep Guardian, a scheduled awakening will be performed each night with the Lully pod.\n\nDuring the initial and therapeutic phases of this study, participants are asked to enter responses daily into a Lully Study app. The app will send a prompt each morning. The questions the participant is prompted to answer serve to document occurrence of bedwetting and the degree of wetness.\n\nIn addition, the family will complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals throughout the study.', 'armGroupLabels': ['Two: Study Phases (S2 and S1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hopspital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Benjamin M Whittam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Pediatric Urology, Riley Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Urology', 'investigatorFullName': 'Benjamin Whittam', 'investigatorAffiliation': 'Indiana University'}}}}