Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2025-12-25 @ 8:10 PM
Study NCT ID:
NCT07183735
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2025-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Crossover Trial to Examine the Efficacy of a Powder to Improve Sleep Quality and Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance 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'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-14', 'studyFirstSubmitDate': '2025-08-07', 'studyFirstSubmitQcDate': '2025-09-14', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in sleep quality as measured by the Sleep Quality Scale (SQS)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6', 'description': 'Sleep quality will be assessed using the self-reported Sleep Quality Scale (SQS), a validated questionnaire evaluating subjective sleep quality.'}, {'measure': 'Change in sleep quantity and architecture as measured by sleep tracker', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6', 'description': 'Objective sleep metrics (e.g., time to fall asleep, deep sleep, REM sleep, sleep transitions, sleep duration, and frequency of waking) will be collected using a sleep tracking device.'}], 'secondaryOutcomes': [{'measure': 'Change in perceived restfulness as measured by self-reported questionnaire', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6', 'description': 'Participants will report perceived restfulness levels to assess subjective recovery and rest post-intervention.'}, {'measure': 'Change in overall energy levels as measured by self-reported questionnaire', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6', 'description': 'Participants will rate their energy levels using a structured questionnaire.'}, {'measure': 'Change in emotional well-being as measured by self-reported questionnaire', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6', 'description': 'Emotional well-being will be assessed using a validated self-report measure.'}, {'measure': 'Change in cognitive function as measured by self-reported questionnaire', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6', 'description': 'Cognitive function will be assessed through a participant questionnaire evaluating attention, memory, and mental clarity.'}, {'measure': 'Change in dietary behavior (e.g., hunger levels) as measured by self-reported questionnaire', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6', 'description': 'Participants will report perceived hunger levels and related dietary behavior using a structured questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep Quality'], 'conditions': ['Sleep', 'Sleep Disorder']}, 'descriptionModule': {'briefSummary': "This is a randomized, placebo-controlled crossover study to assess the efficacy of BEAM's Dream Powder in improving sleep health among 40 adults. Participants will use a placebo for 2 weeks, followed by the test product for 4 weeks, with sleep data collected via questionnaires and a Fitbit sleep tracker."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female\n* 18+ years old\n* Self-reported issues with sleeping, falling asleep, or staying asleep.\n* Willing to discontinue any supplements, medications, herbal remedies, or melatonin products used to assist with sleep for the study duration.\n* Willing to avoid introducing any other supplements, medications, herbal remedies, or melatonin products used to assist with sleep for the duration of this trial.\n* Willing to maintain their standard sleep pattern and activity level for the duration of the study.\n* Be generally healthy and not live with any uncontrolled chronic disease.\n\nExclusion Criteria:\n\n* Diagnosed with any chronic sleep condition, including but not limited to insomnia, narcolepsy, or sleep apnea.\n* Women who are pregnant, breastfeeding, or trying to conceive.\n* Anyone unwilling or unable to follow the study protocol.\n* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.\n* Is currently undergoing, or planning to undergo, any significant medical procedures during the study period.\n* Has undergone any surgeries or invasive treatments in the last six months.\n* A history of severe allergic reactions, including but not limited to any of the product's ingredients.\n* Anyone with a nut allergy.\n* Heavy drinkers. A heavy drinker is considered to be a woman who drinks 8 or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week.\n* Anyone who uses illicit drugs.\n* Use any prescription medication, over-the-counter, or herbal remedies that can affect sleep.\n* Have a job that involves working the third or night shifts."}, 'identificationModule': {'nctId': 'NCT07183735', 'briefTitle': 'A Crossover Trial to Examine the Efficacy of a Powder to Improve Sleep Quality and Performance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beam'}, 'officialTitle': 'A Crossover Trial to Examine the Efficacy of a Powder to Improve Sleep Quality and Performance', 'orgStudyIdInfo': {'id': '20417'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BEAM Dream Powder', 'interventionNames': ['Dietary Supplement: BEAM Dream Powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo Control']}], 'interventions': [{'name': 'BEAM Dream Powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A powdered sleep supplement. Administered daily, mixed with 8-12 oz hot water, 30 minutes before bedtime during Weeks 3-6.', 'armGroupLabels': ['BEAM Dream Powder']}, {'name': 'Placebo Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A powdered placebo product. Administered daily, mixed with 8-12 oz hot water, 30 minutes before bedtime during Weeks 1-2.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89118', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beam', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}