Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-03-02 @ 4:37 PM
Study NCT ID:
NCT05261659
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2022-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Memory Reactivation During REM Sleep in Patients With Social Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007171', 'term': 'Implosive Therapy'}], 'ancestors': [{'id': 'D003887', 'term': 'Desensitization, Psychologic'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-01', 'studyFirstSubmitDate': '2022-02-19', 'studyFirstSubmitQcDate': '2022-02-19', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Liebowitz Social Anxiety Scale', 'timeFrame': '3 months', 'description': 'Validated self-report measure used to assess degree of social anxiety on a scale of 0 to 144 (higher values reflect a worse outcome)'}], 'primaryOutcomes': [{'measure': 'Root mean square of the successive [R-R intervals] differences', 'timeFrame': '1 day', 'description': 'The RMSSD is used to estimate the vagally mediated changes in heart rate variability.'}, {'measure': 'Root mean square of the successive [R-R intervals] differences', 'timeFrame': '1 week', 'description': 'The RMSSD is used to estimate the vagally mediated changes in heart rate variability.'}, {'measure': 'Subjective Units of Distress Scale', 'timeFrame': '1 day', 'description': 'Validated rating of subjective distress on a scale of 0 to 10 (higher values reflect a worse outcome)'}, {'measure': 'Subjective Units of Distress Scale', 'timeFrame': '1 week', 'description': 'Validated rating of subjective distress on a scale of 0 to 10 (higher values reflect a worse outcome)'}], 'secondaryOutcomes': [{'measure': 'Non-specific skin conductance responses', 'timeFrame': '1 day', 'description': 'The skin conductance response measures sympathetic nervous system activation.'}, {'measure': 'Non-specific skin conductance responses', 'timeFrame': '1 week', 'description': 'The skin conductance response measures sympathetic nervous system activation.'}, {'measure': 'Change of fear in dreams (average of fear during the second week with stimulations minus the first week without stimulations)', 'timeFrame': '1 week', 'description': 'Use of a dream diary where the emotion of fear is graded in a dichotomous way (presence/absence).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Social Anxiety Disorder', 'Sleep']}, 'descriptionModule': {'briefSummary': "With this study, the investigators aim to use sleep and dreaming in order to enhance exposure therapy for social anxiety disorder (SAD), by pairing the positive feedback phase of exposure (public talk) to an auditory stimulus during wake (associated sound) and subsequently applying this stimulus during sleep (targeted memory reactivation, TMR). Exposure therapy sessions will take place in a virtual reality (VR) environment, while physiological measures during the preparation phase of public talk such as heart rate variability (HRV), skin conductance response (SCR) and subjective level of anxiety (SUDS) will be used in order to assess treatment efficiency across the sessions. Patients with SAD according to DSM-5 criteria will be included.\n\nThe main hypothesis of this study is that participants who are presented with the associated sound during sleep (TMR group) will have reduced intensity of social anxiety compared to participants with no such association (control group), after both a full night's sleep with auditory stimulation during REM sleep in the laboratory, and after 1 week of stimulation during REM sleep at home. In addition, it is expected that fear-related dreams may correlate with anxiety levels during wakefulness after 1 week of stimulation at home."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with social anxiety disorder (according to DSM-5 criteria and Liebowitz Social Anxiety Scale \\> 65)\n* aged between 16 and 40 yo\n* no current treatment for SAD (cognitive-behavioral therapy, medications)\n\nExclusion Criteria:\n\n* mood disorder, psychosis,other anxiety disorder or other mental disorders according to DSM-5 criteria\n* sleep disorder (e.g.,insomnia disorder, obstructive sleep apnea syndrome, restless legs syndrome) according to DSM-5 criteria\n* use of psychiatric medication\n* current treatment for SAD (cognitive-behavioral therapy, medications)\n* neurological disease'}, 'identificationModule': {'nctId': 'NCT05261659', 'briefTitle': 'Targeted Memory Reactivation During REM Sleep in Patients With Social Anxiety Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Using Sleep and Dreaming to Treat Social Anxiety', 'orgStudyIdInfo': {'id': '2018-01335'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TMR group', 'description': 'Patients will receive a sound while they receive a positive feedback for their performance of exposure therapy (ET). They will also receive the sound during REM sleep.', 'interventionNames': ['Behavioral: Exposure Therapy and Targeted memory reactivation during REM sleep']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients will not receive a sound while they receive a positive feedback for their performance of exposure therapy (ET). They will receive the same sound as the experimental group during REM sleep under the same conditions.', 'interventionNames': ['Behavioral: Exposure Therapy']}], 'interventions': [{'name': 'Exposure Therapy and Targeted memory reactivation during REM sleep', 'type': 'BEHAVIORAL', 'description': 'Emerging evidence shows that REM sleep plays a causal role in extinction learning, emotion regulation and consolidation of emotionally positive memories. By using targeted memory reactivation (TMR), a known method where a sound is associated with a waking experience (i.e., positive feedback in this study) and strengthening it during REM sleep, the investigators aim to accelerate the remission of social anxiety disorder.', 'armGroupLabels': ['TMR group']}, {'name': 'Exposure Therapy', 'type': 'BEHAVIORAL', 'description': 'These patients will receive the classic treatment of Exposure Therapy (ET) for social anxiety disorder without any association with a sound.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1225', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Center for Sleep Medicine, University Hospitals of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Clinical Fellow', 'investigatorFullName': 'Lampros Perogamvros', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}