Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2026-05-27 @ 12:30 PM
Study NCT ID:
NCT04245761
Status:
COMPLETED
Last Update Posted:
2021-09-10
First Post:
2020-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Non-Comparative Study To Evaluate Administration Of a New Nutraceutical
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pilot, open, non-comparative, multicenter study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2020-01-27', 'studyFirstSubmitQcDate': '2020-01-28', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-sleep arousal scale (PSAS);', 'timeFrame': '30 days', 'description': 'Change in Pre-sleep arousal scale PSAS from a maxim of 24 to a minimum of 16 is a positive outcome for the investigational product'}], 'secondaryOutcomes': [{'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': '30 days', 'description': 'Minimal score for ISI scale is 0 to 7 (clinical insignificant insomnia), 8 to 14 (bellow average insomnia), 15 to 21 (moderate insomnia) and 22 to 28 (severe insomnia)'}, {'measure': 'Patient Health Questionnaire QoL (PHQ-9)', 'timeFrame': '30 days', 'description': 'The minimal score of this questionnaire is 0 (patient is not affected by insomnia) and the maximum score is 27 ( patient is highly affected by insomnia)'}, {'measure': 'Cognitive subscale of Pre-sleep arousal scale (PSAS)', 'timeFrame': '30 days', 'description': 'The minimal score of this questionnaire is 0 (patient is not affected by insomnia) and the maximum score is 27 ( patient is highly affected by insomnia)'}, {'measure': 'Somatic subscale of PSAS (Pre-sleep arousal scale)', 'timeFrame': '30 days', 'description': 'The minimal score of this questionnaire is 0 (patient is not affected by insomnia) and the maximum score is 27 ( patient is highly affected by insomnia)'}, {'measure': 'Global Assessment of Safety', 'timeFrame': '30 days', 'description': 'it will be reported by the subject using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. Global Assessment of Safety will be evaluated at the last visit.'}, {'measure': 'Restorative Sleep Questionnaire-Daily (RSQ-D)', 'timeFrame': '30 days', 'description': 'Provides a valid and reliable measure for assessing nonrestorative sleep complaints. It includes 9 self-report items related to various aspects of the restorative quality of sleep. The paper printed questionnaire will be completed on a daily basis by subject upon awakening. Minimum score is 0 and maximum is 100. The higher the score, the better the sleep quality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Disorder']}, 'descriptionModule': {'briefSummary': 'The Research Hypothesis for the present pilot study in a special care setting is that in a population suffering of mild and recent sleep disorders the pre-sleep arousal measured by the Pre-Sleep Arousal Scale (PSAS) after 30 days of oral administration with a nutraceutical composed of hawthorn, lavender and hop (Sonidor®) shall significantly improve in comparison with the baseline condition.', 'detailedDescription': 'Sonidor® was developed as a nutraceutical composed of hawthorn, lavender and hop inducing sleep and relaxation in subjects with mild sleep disturbances. In addition, the Sonidor® innovative three-layer-tablet formulation should allow the active components to be released with different speeds into the gastrointestinal tract exerting a synergistic action to induce sleep-promoting effects.\n\nPrimary objective is to have a preliminary evaluation of the efficacy of Sonidor® in subjects affected by persistent mild sleep disorders (difficulty in initiating sleep for at least 1 month and reduced quality of sleeping) to whom in special care setting have been suggested sleep hygiene guidelines and administered the tested nutraceutical for one month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men and women, aged 18 to 70 years with persistent, recent (at least 1 month) and mild sleep disorders related to pre-sleep arousal and reduced quality of sleeping;\n2. PSAS at baseline between 16 and 24;\n3. ISI at baseline ≥ 12;\n4. Able to communicate adequately with the Investigator and to comply with the requirements for the entire study;\n5. Capable of and freely willing to provide written informed consent prior to participating in the study;\n\nExclusion Criteria:\n\nl. Subjects with Morningness-Eveningness Questionnaire Self-Assessment (MEQSA) values between 16 and 41; 2. Pregnancy and/or breast-feeding; 3. Subjects assuming beta blockers, hypnotic or sedative drugs or other nutraceuticals; 4. Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt, or suicidal ideation, or any other psychiatric illness (with the exception of intermittent anxiety); 5. Known intolerance to the tested product or at one of the ingredients (hawthorn, lavender or hop); 6. Drug or alcohol abuse within 12 months of Day 0; 7. All clinical conditions that, at the evaluation of the Investigator, can be referred to as secondary insomnia; 8. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days; 9. Presence of any clinically significant medical condition judged by the investigator to preclude the subject's inclusion in the study;"}, 'identificationModule': {'nctId': 'NCT04245761', 'briefTitle': 'Open Non-Comparative Study To Evaluate Administration Of a New Nutraceutical', 'organization': {'class': 'INDUSTRY', 'fullName': 'Italfarmaco'}, 'officialTitle': 'Pilot Open Non-Comparative Study To Evaluate In Special Care Setting The Administration Of A New Nutraceutical Associated With Sleep Hygiene Guidelines In Subjects Affected By Persistent Mild Sleep Disorders', 'orgStudyIdInfo': {'id': 'DMS/18/SON/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sonidor®', 'description': 'Application: following the summary of product characteristics (l tablet per day) At the 7-day phone call the Investigator can increase the dosage to 2 tablets per day only in non-responding subjects.', 'interventionNames': ['Dietary Supplement: Sonidor®']}], 'interventions': [{'name': 'Sonidor®', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Sonidor® triple layer release tablets are developed with a specialized process to improve stability and bioavailability of the formulation based on hawthorn, lavender and hop extracts. The hawthorn, lavender and hop extracts used to product Sonidor® have an elevated content of vitexin (3%), monoterpens (4% as linalool) and flavonoids (4%), respectively.', 'armGroupLabels': ['Sonidor®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Timișoara', 'state': 'Timiș County', 'country': 'Romania', 'facility': 'Fizio Center', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}], 'overallOfficials': [{'name': 'Cecilia Turcu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fizio Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Italfarmaco', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Opera CRO, a TIGERMED Group Company', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}