Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT06627205
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2024-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2024-10-02', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of Sleep Restriction Therapy', 'timeFrame': 'At end of treatment (approximately week 10)', 'description': 'Acceptability will be assessed using a series of questions rated by participants on a 5-point Likert scale (1-5) with 1 being the least acceptable and 5 being the most acceptable.'}, {'measure': 'Tolerability of Sleep Restriction Therapy', 'timeFrame': 'At end of treatment (approximately week 10)', 'description': 'Tolerability will be assessed using a series of questions rated by participants on a 5-point Likert scale (1-5) with 1 being the least tolerable and 5 being the most tolerable.'}, {'measure': 'Feasibility of Sleep Restriction Therapy', 'timeFrame': 'At end of treatment (approximately week 10)', 'description': 'Feasibility will be assessed using a series of questions rated by participants on a 5-point Likert scale (1-5) with 1 being the least feasible and 5 being the most feasible.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline on the Sleep Disturbance Scale for Children', 'timeFrame': 'Screening, Baseline, End of Week 2 Treatment, End of Treatment (approximately week 10)', 'description': 'The Sleep Disturbance Scale for Children (SDSC) evaluates various sleep disorders including difficulties in falling asleep and staying asleep, sleep-disordered breathing, arousal disorders, sleep-wake transition disorders, excessive sleepiness, and excessive sweating during sleep. Scores range from 26 to 130. Higher scores on the SDSC are indicative of greater sleep disturbance. This outcome measure will determine the effectiveness of sleep restriction therapy in improving sleep disturbances in children with autism spectrum disorder.'}, {'measure': 'Change in sleep onset latency (Sleep-Wake Diary)', 'timeFrame': 'Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)', 'description': 'This study utilizes a brief sleep-wake diary to collect parent-reported sleep variables (e.g., what time did your child try to sleep last night). Average sleep onset latency will be calculated from the diary for the purposes of this study.'}, {'measure': 'Change in sleep efficiency (Sleep-Wake Diary)', 'timeFrame': 'Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)', 'description': 'This study utilizes a brief sleep-wake diary to collect parent-reported sleep variables (e.g., what time did your child try to sleep last night). Average sleep efficiency will be calculated from the diary for the purposes of this study.'}, {'measure': 'Change in wake after sleep onset duration (Sleep-Wake Diary)', 'timeFrame': 'Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)', 'description': 'This study utilizes a brief sleep-wake diary to collect parent-reported sleep variables (e.g., what time did your child try to sleep last night). Average wake after sleep onset will be calculated from the diary for the purposes of this study.'}, {'measure': 'Change in sleep onset latency (Actigraphy)', 'timeFrame': 'Baseline, Week 1, Week 2', 'description': 'Children wear an actigraphy monitor for the purposes of collecting objective information about sleep onset latency (time taken to fall asleep).'}, {'measure': 'Change in sleep efficiency (Actigraphy)', 'timeFrame': 'Baseline, Week 1, Week 2', 'description': 'Children wear an actigraphy monitor for the purposes of collecting objective information about sleep efficiency (percentage of time in bed that the child is actually asleep).'}, {'measure': 'Change in Wake After Sleep Onset (Actigraphy)', 'timeFrame': 'Baseline, Week 1, Week 2', 'description': 'Children wear an actigraphy monitor for the purposes of collecting objective information about wake after sleep onset duration (the amount of time spent awake after falling asleep)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism', 'Sleep', 'Intervention'], 'conditions': ['Autism Spectrum Disorder (ASD)', 'Autism']}, 'referencesModule': {'references': [{'pmid': '35635067', 'type': 'BACKGROUND', 'citation': 'Han GT, Trevisan DA, Abel EA, Cummings EM, Carlos C, Bagdasarov A, Kala S, Parker T, Canapari C, McPartland JC. Associations between sleep problems and domains relevant to daytime functioning and clinical symptomatology in autism: A meta-analysis. Autism Res. 2022 Jul;15(7):1249-1260. doi: 10.1002/aur.2758. Epub 2022 May 30.'}, {'pmid': '35712855', 'type': 'BACKGROUND', 'citation': 'Cain N, Richardson C, Bartel K, Whittall H, Reeks J, Gradisar M. A randomised controlled dismantling trial of sleep restriction therapies for chronic insomnia disorder in middle childhood: effects on sleep and anxiety, and possible contraindications. J Sleep Res. 2022 Dec;31(6):e13658. doi: 10.1111/jsr.13658. Epub 2022 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this open label trial is to examine the acceptability, tolerability, and feasibility and preliminary effectiveness of sleep restriction therapy for sleep problems in children with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of parent-training in delivering the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosed with autism spectrum disorder (based on history, review of available medical records including diagnostic testing, e.g., Autism Diagnostic Observation Schedule and/or Autism Diagnostic Interview-Revised, Childhood Autism Rating Scale-2)\n* with sleep disturbances (based on clinical interview, and Sleep Disturbance Scale for Children score \\> 38)\n* stable pre-existing medication plans for at least 2 weeks\n* no planned changes in psychosocial and biomedical interventions during the intervention\n* an English-speaking parent able to consistently participate in study procedures\n* reside in California, USA\n\nExclusion Criteria:\n\n* parent or child diagnosed with severe psychiatric disorder or unstable medical problem\n* children with active seizures or epilepsy\n* primary sleep disorder is a circadian rhythm sleep-wake disorder, as determined by the sleep interview and Children's ChronoType Questionnaire.\n* current active trial of sleep restriction therapy or history of an adequate trial of sleep restriction therapy."}, 'identificationModule': {'nctId': 'NCT06627205', 'briefTitle': 'Sleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Sleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': 'IRB-76796'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep Restriction Therapy', 'description': 'Participants attend telehealth sessions once per week for three weeks and implement sleep restriction therapy in between sessions and for 4 weeks during a follow-up period.', 'interventionNames': ['Behavioral: Sleep Restriction Therapy']}], 'interventions': [{'name': 'Sleep Restriction Therapy', 'type': 'BEHAVIORAL', 'description': 'Therapist led sleep restriction therapy sessions.', 'armGroupLabels': ['Sleep Restriction Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emma Baker, PhD', 'role': 'CONTACT', 'email': 'ekbaker@stanford.edu.au'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Emma K Baker, MPsych(Clin), PhD', 'role': 'CONTACT', 'email': 'ekbaker@stanford.edu', 'phone': '6507361235'}, {'name': 'Robin Libove, BS', 'role': 'CONTACT', 'email': 'rlibove@stanford.edu', 'phone': '6507361235'}], 'overallOfficials': [{'name': 'Emma K Baker, MPsych(Clin), PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No current plan to share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Antonio Hardan', 'investigatorAffiliation': 'Stanford University'}}}}