Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-01-12 @ 4:59 PM
Study NCT ID:
NCT06687161
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2024-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Insomnia in Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will test the combination of neuromodulation by repetitive transcranial magnetic stimulation (rTMS) with cognitive behavioral therapy for insomnia (CBT-I). All participants will receive the active intervention. Participants will be randomized to receive one or two treatments of rTMS per day.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cortical Plasticity', 'timeFrame': 'Baseline (first day of TMS therapy)', 'description': 'Cortical plasticity is a measure of the efficacy of long-term potentiation (LTP)-neuroplasticity. It will be measured as the change in the TMS-evoked EEG potential (TEP) following iTBS.'}], 'primaryOutcomes': [{'measure': 'Insomnia Severity Index', 'timeFrame': 'Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up)', 'description': "The Insomnia Severity Index (ISI) is a brief self-assessment tool used to measure the severity of insomnia. It consists of seven questions that evaluate sleep problems, their impact on daily life, and the individual's level of concern about their sleep issues. The total score helps to categorize the severity of insomnia from mild to severe."}, {'measure': 'Paired Associative Learning test (CANTAB)', 'timeFrame': 'Baseline, Week 3, Week 12, 6 Months', 'description': "The Paired Associative Learning (PAL) test is a computer-based cognitive assessment that evaluates memory and learning. In the test, participants are shown patterns and must remember the locations of these patterns on a screen. It is commonly used to assess spatial memory and detect early signs of memory-related conditions like Alzheimer's disease."}, {'measure': 'Spatial Working Memory test (CANTAB)', 'timeFrame': 'Baseline, Week 3, Week 12, 6 months', 'description': 'The Spatial Working Memory (SWM) test is a computer-based task used to assess the ability to retain and manipulate spatial information. Participants must find hidden tokens within a series of boxes while avoiding revisiting previously searched locations. This test measures executive function and memory, and is often used in research on conditions affecting cognitive function.'}], 'secondaryOutcomes': [{'measure': 'Multidimensional Fatigue Symptoms Inventory', 'timeFrame': 'Baseline, Week 3, Week 12, 6 months', 'description': "The Multidimensional Fatigue Symptom Inventory (MFSI) is a questionnaire designed to assess different aspects of fatigue. It measures five dimensions: general fatigue, emotional fatigue, physical fatigue, mental fatigue, and vigor (energy levels). The tool helps to provide a comprehensive understanding of an individual's fatigue symptoms and their impact on daily functioning."}, {'measure': 'Center for Epidemiologic Studies Depression scale', 'timeFrame': 'Baseline, Week 3, Week 12, 6 months', 'description': 'The Center for Epidemiologic Studies Depression scale (CES-D) is a self-report questionnaire designed to measure symptoms of depression in the general population. It consists of 20 questions that assess mood, behavior, and physical symptoms associated with depression over the past week. The CES-D is commonly used in research and clinical settings to screen for depressive symptoms and monitor changes in mood.'}, {'measure': 'Match to Sample Visual Search test (CANTAB)', 'timeFrame': 'Baseline, Week 3, Week 12, 6 months', 'description': 'The Match to Sample Visual Search (MTS) test is a computerized assessment that measures visual recognition and attention. In the test, participants are shown a sample pattern and must quickly identify the matching pattern from a selection of similar images. It evaluates processing speed, visual memory, and attention to detail, and is often used to study cognitive functions in various neurological and psychiatric conditions.'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': 'Baseline, Week 3, Week 12, 6 months', 'description': "The Montreal Cognitive Assessment (MoCA) is a quick test used by doctors and other healthcare professionals to check a person's thinking and memory skills. It takes about 10-15 minutes and looks at things like attention, memory, language, and problem-solving. It's often used to help spot early signs of conditions like dementia or mild cognitive impairment."}, {'measure': 'Sleep efficiency (sleep diaries)', 'timeFrame': 'Week 3, Week 13, 6 months', 'description': 'Sleep Efficiency is a measure derived from sleep diaries that indicates the percentage of time spent asleep while in bed, relative to the total time spent in bed. It is calculated by dividing the total sleep time by the total time in bed and multiplying by 100 to get a percentage. A higher sleep efficiency typically suggests more consolidated sleep, while lower sleep efficiency can indicate difficulties with sleep onset or frequent awakenings.'}, {'measure': 'Sleep After Wake Onset (sleep diaries)', 'timeFrame': 'Week 3, Week 13, Week 40', 'description': 'Sleep After Wake Onset (SAWO) is a measure derived from sleep diaries that captures the amount of time a person manages to sleep after experiencing an initial awakening during the night. It represents the total time spent asleep between waking up and the final morning awakening, providing insight into the continuity of sleep and the ability to return to sleep after disruptions.'}, {'measure': 'Sleep Onset Latency (sleep diaries)', 'timeFrame': 'Week 3, Week 13, Week 40', 'description': 'Sleep Onset Latency (SOL) is a measure derived from sleep diaries that indicates the amount of time it takes to fall asleep after going to bed with the intention of sleeping. It is typically recorded in minutes and reflects how easily a person initiates sleep. Longer sleep onset latency may indicate difficulty falling asleep, while shorter latency suggests quicker sleep initiation.'}, {'measure': 'Sleep efficiency (actigraphy)', 'timeFrame': 'Week 3, Week 13, 6 months', 'description': 'Sleep Efficiency is a measure derived from actigraphy that indicates the percentage of time spent asleep while in bed, relative to the total time spent in bed. It is calculated by dividing the total sleep time by the total time in bed and multiplying by 100 to get a percentage. A higher sleep efficiency typically suggests more consolidated sleep, while lower sleep efficiency can indicate difficulties with sleep onset or frequent awakenings.'}, {'measure': 'Sleep After Wake Onset (actigraphy)', 'timeFrame': 'Week 3, Week 13, Week 40', 'description': 'Sleep After Wake Onset (SAWO) is a measure derived from actigraphy that captures the amount of time a person manages to sleep after experiencing an initial awakening during the night. It represents the total time spent asleep between waking up and the final morning awakening, providing insight into the continuity of sleep and the ability to return to sleep after disruptions.'}, {'measure': 'Sleep Onset Latency (actigraphy)', 'timeFrame': 'Week 3, Week 13, Week 40', 'description': 'Sleep Onset Latency (SOL) is a measure derived from actigraphy that indicates the amount of time it takes to fall asleep after going to bed with the intention of sleeping. It is typically recorded in minutes and reflects how easily a person initiates sleep. Longer sleep onset latency may indicate difficulty falling asleep, while shorter latency suggests quicker sleep initiation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['transcranial magnetic stimulation', 'neuromodulation', 'cognitive behavioral therapy', 'CBT-I', 'TMS', 'sleep'], 'conditions': ['Mild Cognitive Impairment (MCI)', 'Insomnia']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to test a new way to improve sleep quality in persons living with mild cognitive impairment. The treatment combines a safe and gentle way to stimulate the brain, called transcranial magnetic stimulation, with a psychological treatment, called cognitive behavioral therapy for insomnia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 60 years or older\n* Speak and read English\n* Clinical diagnosis of MCI or Subjective Cognitive Impairment (SCI)-a perceived gradual worsening in cognitive ability relative to one's younger self, or peer group-reported by either the participant or informant\n* Reported insomnia symptoms (sleep-onset and/or sleep maintenance) that cause significant distress or impairment in social, occupational, or other areas of functioning over the past three months\n* Have access to an Internet-enabled computer or tablet at home, or ability to connect a BIDMC-provided tablet to the internet, with private space to complete cognitive testing\n* Capable of and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Evidence of significant cognitive impairment or dementia\n* Contraindications for TMS or MRI\n* Current psychological treatment for insomnia\n* Uncontrolled moderate-to-severe obstructive sleep apnea or other untreated sleep disorder (e.g., Restless Leg Syndrome, Periodic Limb Movement Disorder, parasomnia). Sleep apnea that is managed (e.g., regular use of a CPAP) and stable for ≥3 months is allowed.\n* Diagnosis of Parkinson's disease, Huntington's disease, Lewy-Body disease, or other neurological condition known to impact sleep\n* Current diagnosis of major psychiatric disorder (well-controlled depression or anxiety is permitted)\n* Current opiate/opioid use\n* Alcohol or drug abuse within the past year\n* Irregular sleep schedule (bedtime before 8pm/after 2am OR wake time before 4am/after 10am), unless participant states they are willing and able to change if prompted."}, 'identificationModule': {'nctId': 'NCT06687161', 'briefTitle': 'Treating Insomnia in Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Neuromodulation and Cognitive Behavioral Therapy for Insomnia in MCI', 'orgStudyIdInfo': {'id': '2024P000708'}, 'secondaryIdInfos': [{'id': 'A2024034S', 'type': 'OTHER_GRANT', 'domain': 'BrightFocus Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'One (1) TMS treatment per day plus CBT-I', 'description': 'One (1) daily treatment of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 10 days (2 weeks) followed by a 9-week Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (TMS) therapy', 'Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Two (2) TMS treatments per day plus CBT-I', 'description': 'Two (2) daily treatments, spaced 1 hour apart, of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 10 days (2 weeks) followed by a 9-week Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (TMS) therapy', 'Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation (TMS) therapy', 'type': 'DEVICE', 'otherNames': ['Intermittent theta-burst stimulation (iTBS)'], 'description': 'Each treatment consists of 600 TMS pulses (\\~3 minutes) applied to the L-DLPFC', 'armGroupLabels': ['One (1) TMS treatment per day plus CBT-I', 'Two (2) TMS treatments per day plus CBT-I']}, {'name': 'Cognitive behavioral therapy for insomnia (CBT-I)', 'type': 'BEHAVIORAL', 'otherNames': ['SHUTi OASIS'], 'description': '9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness)', 'armGroupLabels': ['One (1) TMS treatment per day plus CBT-I', 'Two (2) TMS treatments per day plus CBT-I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alex Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'adiamon2@bidmc.harvard.edu', 'phone': '617-667-0386'}, {'name': 'Peter J Fried, PhD', 'role': 'CONTACT', 'email': 'pfried@bidmc.harvard.edu', 'phone': '617-807-0612'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Alex Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'adiamon2@bidmc.harvard.edu', 'phone': '617-667-0386'}, {'name': 'Peter J Fried, PhD', 'role': 'CONTACT', 'email': 'pfried@bidmc.harvard.edu', 'phone': '617-807-0612'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Approximately 1 year following the conclusion of the study for at least 5 years', 'ipdSharing': 'YES', 'description': 'De-identified data will be made available for qualified researchers approximately.', 'accessCriteria': 'Researchers at universities and academic medical centers can request de-identified data by sending an email to the PI and describing the nature of the request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Virginia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Peter J. Fried', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}