Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT01926405
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2013-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Amylase and Hypersomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'id': 'D009290', 'term': 'Narcolepsy'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-12', 'studyFirstSubmitDate': '2013-08-12', 'studyFirstSubmitQcDate': '2013-08-19', 'lastUpdatePostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the expression and enzymatic activity of salivary amylase.', 'timeFrame': '3 days', 'description': 'Show an increase of salivary amylase for children with hypersomnia or narcolepsy compared to a group of children matched on age and sex.'}], 'secondaryOutcomes': [{'measure': 'Measurement of the mean sleep onset latency using the Multiple Sleep Latency Test (MSLT)', 'timeFrame': '3 days', 'description': 'To highlight a correlation between the degree of somnolence measured by MSLT and the rate of salivary amylase.'}, {'measure': 'Measurement of the somnolence using Epworth and Karolinska scales', 'timeFrame': '3 days', 'description': 'To highlight a correlation between the degree of somnolence measured by the scales and the rate of salivary amylase.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypersomnia', 'narcolepsy', 'amylase', 'salivary sampling'], 'conditions': ['Hypersomnia in Children']}, 'descriptionModule': {'briefSummary': 'Hypersomnia is defined as a reduced ability to remain awake during the day. There are basically two types of central hypersomnia: narcolepsy and idiopathic hypersomnia. Currently, the diagnosis of these sleep disorders is based on polysomnographic recordings which is difficult to access. Tests of sleepiness (Epworth, Karolinska) are subjective.\n\nA biological marker of sleepiness, easily accessible and measurable, would be very useful for the diagnosis and therapeutic follow up of excessive diurnal sleepiness. Salivary secretions appear as good physiological markers. Studies have shown for healthy subjects, that the expression and activity of salivary amylase are increased when subjects are deprived of sleep.\n\nThe investigators propose to explore the usefulness of salivary biomarkers (including amylase) as a new non-invasive and simple technique for the assessment of excessive daytime sleepiness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects with hypersomnia (narcolepsy or idiopathic):\n\n* Children and adolescents with hypersomnia (according to ICSD diagnostic criteria 2); narcolepsy or idiopathic hypersomnia (with or without lengthening of sleep),\n* aged \\> 6 years and \\<18 years,\n* no treatment,\n* Parent consent\n\nControl subjects:\n\n* healthy children and adolescents without any known pathology,\n* aged \\> 6 years and \\<18 years,\n* matched on sex and age\\> 6 years - \\<12 years,\\> 12 - \\<18 years)\n* Parent Consent\n\nExclusion Criteria:\n\n* Subjects with hypersomnia (narcolepsy or idiopathic):\n* Secondary narcolepsy,\n* Symptomatic hypersomnia,\n* Restless legs syndrome,\n* Sleep apnea syndrome,\n* Severe neurological, psychiatric, cognitive or endocrinological concomitant disease.\n\nControl subjects:\n\n* Hypersomnia,\n* Restless legs syndrome,\n* Sleep apnea syndrome,\n* Severe neurological, psychiatric, cognitive or endocrinological concomitant disease,\n* Sleep disorder evaluated by a score \\> 70 on the Sleep Disturbance Scale for Children19,\n* Excessive daytime sleepiness according to Epworth scales (score \\> 10),\n* Abnormal sleep time according to the age (sleep diary).'}, 'identificationModule': {'nctId': 'NCT01926405', 'acronym': 'Amylase', 'briefTitle': 'Amylase and Hypersomnia', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of Excessive Diurnal Sleepiness by the Expression and Activity of Salivary Amylase in Children With Hypersomnia.', 'orgStudyIdInfo': {'id': '2011.681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Subjects with narcolepsy or with idiopathic hypersomnia', 'interventionNames': ['Procedure: saliva collection']}, {'type': 'OTHER', 'label': 'Control patients with no sleeping disorder', 'interventionNames': ['Procedure: saliva collection']}], 'interventions': [{'name': 'saliva collection', 'type': 'PROCEDURE', 'description': 'collection of saliva', 'armGroupLabels': ['Control patients with no sleeping disorder', 'Subjects with narcolepsy or with idiopathic hypersomnia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Hôpital Femme-Mère-Enfant, Exploration et pathologie du sommeil', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}