Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:55 AM
Study NCT ID:
NCT07485959
Status:
COMPLETED
Last Update Posted:
2026-03-20
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of NP-2006 on Sleep Quality and Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score', 'timeFrame': 'Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks', 'description': 'The PSQI is a self-report questionnaire that assesses sleep quality. The total score ranges from 0 to 21, where lower scores indicate better sleep quality. A decrease in the score represents an improvement in sleep health.'}, {'measure': 'Change from Baseline in Insomnia Severity Index (ISI) Score', 'timeFrame': 'Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks', 'description': "The ISI is a brief instrument that assesses the severity of insomnia. The total score ranges from 0 to 28, where 0-7 indicates 'no clinically significant insomnia' and higher scores indicate more severe insomnia. A lower score represents a better outcome (improvement in insomnia symptoms)."}, {'measure': 'Change from Baseline in Epworth Sleepiness Scale (ESS) Score', 'timeFrame': 'Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks', 'description': 'The ESS is used to determine the level of daytime sleepiness. The total score ranges from 0 to 24. A lower score indicates less daytime sleepiness, representing a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Sleep Efficiency measured by Actigraphy', 'timeFrame': 'Baseline (Day 0), End of treatment (Day 29)', 'description': 'Sleep efficiency is the ratio of total sleep time to time spent in bed, measured using a wrist-worn actigraph. The value is expressed as a percentage (%). A higher percentage indicates better sleep quality.'}, {'measure': 'Change from Baseline in Total Sleep Time (TST) from Sleep Diary', 'timeFrame': 'Baseline (Day 0), End of treatment (Day 29)', 'description': 'Participants recorded their total sleep time daily in a sleep diary. The unit of measure is minutes (min). A higher value indicates an improvement in sleep duration and health.'}, {'measure': 'Change from Baseline in Subjective Sleep Quality Score', 'timeFrame': 'Baseline (Day 0), End of treatment (Day 29)', 'description': "Participants rated their sleep quality on a 5-point Likert scale, where 1 indicates 'Very Poor' and 5 indicates 'Very Good'. A higher score represents a better outcome (improved sleep quality)."}, {'measure': 'Change from Baseline in Sleep Latency measured by Polysomnography (PSG)', 'timeFrame': '0, 4, 8, 12 weeks', 'description': 'Sleep latency is the time it takes to fall asleep from lights-out, measured by professional PSG equipment. The unit of measure is minutes (min). A lower value indicates a better outcome (faster sleep onset).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Disorder (Disorder)']}, 'descriptionModule': {'briefSummary': 'The main objective will be to assess the effect of NP-2006 on sleep efficiency in volunteers presented with persistent subclinical insomnia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Those who agreed to participate in this study and signed a written consent form\n2. Adults aged 19 to 65 years, male or female\n3. Those with poor sleep quality (PSQI score \\> 5 points)\n\nExclusion Criteria:\n\n1. Those with severe sleep disturbances (ISI ≥ 22 points)\n2. Those with severe daytime sleepiness (ESS ≥ 16 points)\n3. Those with the following conditions:\n\n * Snoring, sleep apnea, restless legs syndrome, periodic limb movement disorder (PLMD), depression, narcolepsy, or respiratory disease that cause sleep disturbances\n * Itching, nocturia, chronic pain, or muscle cramps that affect sleep\n * Uncontrolled diabetes or hypertension\n4. Those experiencing changes that could cause excessive stress within 2 weeks of the first visit: death of a spouse, family discord, lawsuits/disputes, sudden financial difficulties, immigration, etc.\n5. Those taking medications (corticosteroids, psychotropic medications, etc.) that could affect sleep within 1 month of the first visit or expected to take them during the study participation\n6. Those receiving hormone therapy\n7. Those who regularly consume excessive alcohol\n\n * Men \\> 210 g/week (approximately 4 bottles of soju/week, approximately 4 glasses/day)\n * Women \\> 140 g/week (approximately 2.5 bottles of soju/week, approximately 2.5 glasses/day)\n8. Those who smoke excessively (\\> 10 cigarettes/day) or show withdrawal symptoms\n9. Those who consume excessive amounts of caffeine (\\> 3 cups/day)\n10. Those who work night shifts or have irregular bedtimes due to their job\n11. Those who have traveled or plan to travel long distances to a country with a different time zone within 1 month of the first visit\n12. Those with a BMI of 18 kg/m2 or less or 35 kg/m2 or more\n13. Those who have continuously taken herbal medicines or health functional foods that may affect sleep within 1 month of the first visit\n14. Those who are hypersensitive to ingredients in the test or control foods or have experienced severe food allergies\n15. Those who have participated in a clinical trial within 1 month of the first visit\n16. Those who are pregnant or lactating, or who are planning to become pregnant\n17. Those who the researcher deems unsuitable for participation in this study'}, 'identificationModule': {'nctId': 'NCT07485959', 'briefTitle': 'The Effect of NP-2006 on Sleep Quality and Health', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanpoong Nature Pharm Co., Ltd.'}, 'officialTitle': 'Effect of NP-2006 on Sleep Efficiency and Quality in Healthy Volunteers With Persistent Subclinical Insomnia', 'orgStudyIdInfo': {'id': 'NP2006_HPN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NP-2006', 'description': 'Group that took tablets containing 500mg of NP-2006 (NP-2006, crystalline cellulose, tapioca starch, hydroxypropylmethylcellulose, etc.) 30 to 60 minutes before going to sleep', 'interventionNames': ['Dietary Supplement: NP-2006', 'Dietary Supplement: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Group that took tablets not containing NP-2006 (crystalline cellulose, maltodextrin, lactose mixed powder, hydroxypropylmethylcellulose, etc.) 30 to 60 minutes before bedtime', 'interventionNames': ['Dietary Supplement: NP-2006', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'NP-2006', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take a tablet containing 500 mg of NP-2006 once a day, 30 to 60 minutes before bedtime for 4 weeks.', 'armGroupLabels': ['NP-2006', 'Placebo']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take a placebo tablet (identical in appearance to NP-2006 but containing no active ingredients) once a day, 30 to 60 minutes before bedtime for 4 weeks.', 'armGroupLabels': ['NP-2006', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanpoong Nature Pharm Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}