Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07365566
Status:
RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Assessment in Patients With Idiopathic REM Sleep Behaviour Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020187', 'term': 'REM Sleep Behavior Disorder'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D020923', 'term': 'REM Sleep Parasomnias'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-01-16', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the intensity of chronic pain between patients with iRBD and a control group of patients', 'timeFrame': '2 hours after the inclusion', 'description': 'Measuring the Visual Analog Scale (VAS) between patients with iRBD without diagnosis of PD and a control group of patients diagnosed with narcolepsy type 1 who present RBD (Rapid eye movement sleep behavior disorder).'}], 'secondaryOutcomes': [{'measure': 'Describe semiological characteristics of pain in RBD patients', 'timeFrame': '2 hours after the inclusion', 'description': 'Description of characteristics of pain'}, {'measure': 'Compare the presence of chronic pain', 'timeFrame': '2 hours after the inclusion', 'description': 'Number of patients with chronic pain in both groups for at least 3 months.'}, {'measure': 'Assessing Pain Characteristics', 'timeFrame': '2 hours after the inclusion', 'description': 'Score obtained on pain questionnaires'}, {'measure': 'Assessment of thermal pain threshold and tolerance', 'timeFrame': '2 hours after the inclusion', 'description': 'Results of the quantitative sensory test (thermal thermotest) in both groups'}, {'measure': 'Assessment of correlations between the intensity of chronic pain', 'timeFrame': '2 hours after the inclusion', 'description': 'Correlation between Visual Analogue Scale (VAS) measurements and questionnaire responses'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['parkinson', 'REM sleep', 'pain', 'REM sleep behavior disorder', 'narcolepsy Type 1', 'sleep'], 'conditions': ['REM Sleep Behavior Disorder (iRBD)', 'Narcolepsy Type 1']}, 'descriptionModule': {'briefSummary': "Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease, with over 12 million patients expected globally by 2040. The disease is currently diagnosed at the appearance of motor symptoms, but by then, over 60% of striatal dopaminergic neurons have already been destroyed. Prodromal symptoms such as idiopathic REM Sleep Behavior Disorder (iRBD), anosmia, mood disorders and constipation appear earlier and are listed as criteria for a prodromal PD diagnosis. Identifying early signs is critical to initiate neuroprotective treatments as early as possible. While pain is prevalent and highly disabling in early PD, no data are currently available on pain perception in iRBD patients, whose condition is of the main risk factor for PD development."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Diagnosed with iRBD confirmed by polysomnography;\n* No clinical diagnosis of Parkinson's disease or other diagnosis of neurodegenerative disease;\n* Ability to understand and complete study procedures and questionnaires;\n\nControl group:\n\n* Diagnosed with narcolepsy type 1;\n* Coexisting REM sleep behavior disorder confirmed by polysomnography;\n* Ability to understand and complete study procedures and questionnaires;\n\nExclusion Criteria:\n\n* Diagnosed Parkinson's Disease, dementia with Lewy bodies or multiple system atrophy;\n* Severe depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM V);\n* Inability to complete study procedures or questionnaires."}, 'identificationModule': {'nctId': 'NCT07365566', 'acronym': 'PAIN-iRBD', 'briefTitle': 'Pain Assessment in Patients With Idiopathic REM Sleep Behaviour Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Pain Assessment in Patients With Idiopathic REM Sleep Behaviour Disorder', 'orgStudyIdInfo': {'id': 'RC31/25/0567'}, 'secondaryIdInfos': [{'id': 'ID-RCB', 'type': 'OTHER', 'domain': '2025-A02575-44'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Idiopathic REM sleep Behavior disorder (iRBD) Group', 'description': 'Patients who have an idiopathic REM sleep Behavior Disorder', 'interventionNames': ['Other: Thermo test pain', 'Other: Pain questionnaires', 'Other: No motors symptoms evaluations']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1', 'description': 'patients who have an iRBD and who have type 1 narcolepsy', 'interventionNames': ['Other: Thermo test pain', 'Other: Pain questionnaires', 'Other: No motors symptoms evaluations']}], 'interventions': [{'name': 'Thermo test pain', 'type': 'OTHER', 'description': 'Patients will undergo a pain test, also called a thermotest, which consists of determining pain thresholds using a thermometer applied to the hand.', 'armGroupLabels': ['Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1', 'Idiopathic REM sleep Behavior disorder (iRBD) Group']}, {'name': 'Pain questionnaires', 'type': 'OTHER', 'description': 'Patients will complete various questionnaires about pain', 'armGroupLabels': ['Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1', 'Idiopathic REM sleep Behavior disorder (iRBD) Group']}, {'name': 'No motors symptoms evaluations', 'type': 'OTHER', 'description': 'Patients will complete questionnaires', 'armGroupLabels': ['Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1', 'Idiopathic REM sleep Behavior disorder (iRBD) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emeline Muller', 'role': 'CONTACT', 'email': 'muller.E@chu-toulouse.Fr', 'phone': '05 61 77 87 07', 'phoneExt': '+33'}], 'facility': 'Centre Expert Parkinson Hôpital Pierre Paul Riquet Place du Docteur Baylac', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Christine BREFEL COURBON', 'role': 'CONTACT', 'email': 'christine.brefel-courbon@univ-tlse3.Fr', 'phone': '05 61 77 60 39', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}