Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT02906904
Status:
WITHDRAWN
Last Update Posted:
2018-06-11
First Post:
2016-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Sensitivity in NREM Parasomnia (NOCISOMNIE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013009', 'term': 'Somnambulism'}, {'id': 'D020184', 'term': 'Night Terrors'}], 'ancestors': [{'id': 'D020921', 'term': 'Sleep Arousal Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Material needed for study was not available', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-07', 'studyFirstSubmitDate': '2016-09-06', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of neurophysiological arousal response within 5 seconds after a subthreshold thermoalgic stimulation applied during parasomniac episodes.', 'timeFrame': 'within 5 seconds after stimulation'}], 'secondaryOutcomes': [{'measure': 'Temperature of the thermoalgic stimulation during wakefulness associated with a nociceptive perception of 5/10 on a visual analogic scale', 'timeFrame': 'on inclusion'}, {'measure': 'Minimal temperature of thermoalgic stimulations associated with a neurophysiological arousal response in NREM sleep stage 2', 'timeFrame': 'within 5 seconds'}, {'measure': 'Nociceptive behavioural response', 'timeFrame': 'within 5 seconds after a subthreshold thermoalgic stimulations applied during sleep and parasomniac episodes'}]}, 'conditionsModule': {'conditions': ['NREM Parasomnia', 'Sleepwalking', 'Sleep Terror']}, 'descriptionModule': {'briefSummary': 'Non Rapid Eye Movement (NREM) sleep parasomnias (sleepwalking and sleep terrors) are frequent and disabling sleep disorders characterized by arousal specifically from slow wave sleep (SWS) with dissociated brain activity that may be related to lower nociceptive state. The investigators recently reported frequent subjective complaints of chronic pain, migraine and headache during wakefulness in adult sleepwalkers. They also described frequent analgesia during severe and injuring episodes, suggesting a relationship between dissociated brain activity and nociceptive dysregulation. However, this study did not included objective nociceptive measures and the retrospective assessment of perceived pain during parasomnia episodes over a lifetime span might also introduce a recall bias.\n\nThe aims of the present study are to measure objective pain sensitivity in patients with NREM parasomnias and matched controls during 1) parasomniac episodes, 2) light NREM sleep and SWS, and 3) wakefulness.\n\nFifteen adults with severe NREM parasomnia and 15 age and sex-matched controls will be recruited. A 25 hours (8 AM to 9 AM) sleep deprivation protocol followed by auditory stimulations during SWS will be used to trigger parasomniac episodes. Thermoalgic stimulations of graduate intensity will be applied during wakefulness (8 PM) to determine the nociceptive threshold. During the recovery sleep following the sleep deprivation, the investigators will apply repeated subthreshold thermoalgic stimulations in NREM stage 2, SWS and triggered parasomniac episodes and report the behavioural/neurophysiologic nociceptive responses.\n\nThe investigators hypothesized a lower nociceptive threshold during wakefulness in sleepwalkers and a decrease of the arousabiliy during SWS and parasomniac episodes. This study may help to better understand the etiology and mechanisms underlying the clinical enigma of the nociceptive dysregulation in NREM sleep parasomnias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject from 18 years-old to 45 years-old\n* Affiliated to social security\n* Written informed consent\n\n \\* CASE specific inclusion criteria :\n* NREM parasomnia diagnosed according to the International Classification of Sleep Disorders 3rd edition (ICSD-3) criteria and confirmed by polysomnography assessment\n* Frequent symptomatology (at least 1 episode by week in the past 3 months)\n\n \\* CONTROL specific inclusion criteria :\n* No medical history of NREM parasomnia\n\nExclusion Criteria:\n\n* Known skin allergy to metal\n* Use of psychotropic drugs during the 15 days before the inclusion\n* Use of analgesic drugs during the 15 days before the inclusion\n* A diagnosis of sleep apnea syndrome, periodic limb movements or restless legs syndrome present more than twice a week\n* Medical history of epilepsy\n* Non stable psychiatric disorder\n* Pregnancy, breastfeeding\n* Subject deprived of liberty or protected by law (tutorship, curatorship).'}, 'identificationModule': {'nctId': 'NCT02906904', 'acronym': 'NOCISOMNIE', 'briefTitle': 'Pain Sensitivity in NREM Parasomnia (NOCISOMNIE)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Objective Measures of Pain Sensitivity in NREM Sleep Parasomnia', 'orgStudyIdInfo': {'id': '9540'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CASE (adult sleepwalking patients)', 'interventionNames': ['Other: Case Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'CONTROL (adult healthy volunteers)', 'interventionNames': ['Other: Control Intervention']}], 'interventions': [{'name': 'Case Intervention', 'type': 'OTHER', 'description': '24-hour sleep deprivation protocol, polysomnographic monitoring of the recovery sleep, triggering of parasomniac episodes by auditory stimulations, thermoalgic stimulation (Modulator Sensory Analyzer Thermal Stimulator®) during wakefulness, parasomniac episodes, NREM stage 2 ans SWS', 'armGroupLabels': ['CASE (adult sleepwalking patients)']}, {'name': 'Control Intervention', 'type': 'OTHER', 'description': '24-hour sleep deprivation protocol, polysomnographic monitoring of the recovery sleep, thermoalgic stimulation (Modulator Sensory Analyzer Thermal Stimulator®) during wakefulness, NREM stage 2 ans SWS', 'armGroupLabels': ['CONTROL (adult healthy volunteers)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montpellier', 'country': 'France', 'facility': 'Montpellier University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}