Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-12 @ 4:42 AM
Study NCT ID:
NCT06510335
Status:
COMPLETED
Last Update Posted:
2024-07-22
First Post:
2024-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lavender Essential Oil-based Product System for Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The study includes a single arm. Participants did not know the market name of the products they used. Products were packaged in plain bottles with the instruction label affixed.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-07-15', 'lastUpdatePostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gene expression', 'timeFrame': '6 weeks', 'description': 'Gene expression analysis refers to a genome-wide quantification of methylation. This represents approximately 900,000 gene locations. The main feature performed is a differential methylation analysis to determine what has significantly changed from one time point to another.'}, {'measure': 'Interleukin 6 (pg/mL)', 'timeFrame': '6 weeks', 'description': 'Serum marker for inflammation'}, {'measure': 'Cortisol (ug/mL)', 'timeFrame': '6 weeks', 'description': 'Serum marker for stress response'}, {'measure': 'Uric acid (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Serum marker for inflammation and signal of developing various disease processes'}, {'measure': 'C-reactive protein (mg/L)', 'timeFrame': '6 weeks', 'description': 'Serum marker for inflammation'}, {'measure': 'Minutes awake', 'timeFrame': '6 weeks', 'description': 'Mean nightly minutes awake determined by fitness tracker'}, {'measure': 'Minutes asleep', 'timeFrame': '6 weeks', 'description': 'Mean nightly minutes asleep determined by fitness tracker'}, {'measure': 'Number of awakenings', 'timeFrame': '6 weeks', 'description': 'Mean nightly number of awakenings determined by fitness tracker'}, {'measure': 'Rapid Eye Movement (REM) sleep (minutes)', 'timeFrame': '6 weeks', 'description': 'Mean nightly minutes of REM sleep determined by fitness tracker'}, {'measure': 'Light sleep (minutes)', 'timeFrame': '6 weeks', 'description': 'Mean nightly minutes of light sleep determined by fitness tracker'}, {'measure': 'Deep sleep (minutes)', 'timeFrame': '6 weeks', 'description': 'Mean nightly minutes of deep sleep determined by fitness tracker'}], 'secondaryOutcomes': [{'measure': 'Albumin (g/dL)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Blood urea nitrogen (BUN) (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Creatinine (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Alkaline phosphatase (U/L)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Alanine transaminase (ALT) (U/L)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Aspartate aminotransferase (AST) (U/L)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Calcium (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Carbon Dioxide (mmol/L)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Chloride (mmol/L)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Potassium (mmol/L)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Sodium (mmol/L)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Total bilirubin (mg/dL)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Total protein (g/dL)', 'timeFrame': '6 weeks', 'description': 'Item in comprehensive metabolic panel for safety assessment'}, {'measure': 'Safety/tolerability', 'timeFrame': '6 weeks', 'description': 'This study will monitor the occurrence and frequency of adverse events and safety through participant report and blood analyses.'}, {'measure': 'Leeds Sleep Evaluation Questionnaire (LSEQ)', 'timeFrame': '6 weeks', 'description': 'Validated, self-reported scale for the measurement of sleep quality. The LSEQ is a 10-item scale. Each item is scored 0 to 100. Higher scores indicate better sleep quality.'}, {'measure': 'Short Form-20 (SF-20) scale', 'timeFrame': '6 weeks', 'description': 'Validated, self-reported scale for the assessment of subjective quality of life. The SF-20 is a 20-item scale. Each item is scored 0-100. Higher scores indicate better subjective quality of life.'}, {'measure': 'Functional Outcomes of Sleep Questionnaire (FOSQ)', 'timeFrame': '6 weeks', 'description': 'Validated, self-reported scale for the measurement of sleep quality. The FOSQ is a 10-item scale. Higher scores indicate better sleep-related functional outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lavender essential oil', 'Sleep quality', 'Gene expression'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn whether lavender essential oil-based product system can affect gene expression, serum protein markers, and sleep quality in healthy volunteers. The main questions this study aims to answer are:\n\n* Does the lavender essential oil-based product system affect gene expression and protein markers as measured in blood?\n* Does the lavender essential oil-based product system affect subjective quality of life and sleep assessments?\n* Is daily use of the product system safe, as measured by laboratory tests and adverse events?\n\nThe lavender essential oil-based product system contains three components: an essential oil blend, a topical stick, and a dietary supplement.\n\nParticipants will:\n\n* Receive a fitness tracker to monitor their sleep and physical activity.\n* Use the lavender essential oil-based product system for six weeks total according to this schedule:\n* 1 week: Essential oil blend\n* 1 week: Essential oil blend + topical stick\n* 4 weeks: Essential oil blend + topical stick + dietary supplement\n* Attend two study visits in which they provide blood and urine samples, and complete subjective sleep and quality of life assessments\n* Complete weekly subjective sleep assessments from home', 'detailedDescription': 'This single-blind study will recruit healthy men and women to compare gene expression profile and serum protein markers before and after consumption of sleep system products for 6 weeks. Quality of life and sleep quality will be assessed using subjective surveys and questionnaires. Safety markers (liver and kidney function, hematology, urinalysis, and adverse events) will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, 35-50 years old\n* Non-smokers\n* Local to Pleasant Grove, Utah, and/or willing to come to clinical research center for study visits\n* Willing and able to apply study products internally, topically and aromatically for about 6 weeks\n* Willing to track use of study product on paper forms, via survey, or other means\n* Willing to washout from all over-the-counter sleep aids, internally-consumed essential oils, alcohol, and lavender-based products for approximately 7 weeks\n* Taking \\<100 mg caffeine daily, and willing to avoid consumption of caffeine after 3pm\n* Not working night shift or swing shift\n* Not consistently traveling to other time zones (or willing to arrange schedule to avoid during study)\n* No known medical condition or sensitivity which would make the application of these study products unsafe\n* Own a smart device that can download and run the accelerometer application\n* Willing and able to keep the same sleeping arrangements as much as possible throughout the study\n* Willing to receive and respond to regular texts, emails, and/or phone calls from study staff\n* No pregnancy within the last 60 days or currently breastfeeding (females)\n* Not currently or previously participating in any other clinical trial within the last 30 calendar days\n* Signed informed consent, HIPAA Authorization, and Confidentiality Agreement\n* No major medical conditions (especially cardiac, lung, metabolic, cancer, or sleep) under the active care of a doctor\n* No prescription medications that may interfere with sleep (e.g. attention deficit hyperactivity disorder stimulants, antihistamines, psychiatric drugs, sleep medications, narcotics, etc.)\n* No evidence of medical condition, significant disease or disorder, medication, or surgery within the past 12 months that may, in the judgment of the medical reviewer, put the participant at risk or affect study results, procedures, or outcomes (e.g. obstructive sleep apnea, morbid obesity, cardiometabolic disease, cancer, lung-related conditions)\n* Willing and able (in the opinion of the investigator) to comply with all study requirements and procedures\n\nExclusion Criteria:\n\n* Failure to meet any of the above inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06510335', 'briefTitle': 'Lavender Essential Oil-based Product System for Sleep', 'organization': {'class': 'INDUSTRY', 'fullName': 'dōTERRA International'}, 'officialTitle': 'Evaluation of a Lavender-based Natural Product System for Sleep Support', 'orgStudyIdInfo': {'id': 'DO-123048-SER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lavender essential oil-based product system', 'description': 'Participants used the system in a sequential additive series. They used only the oil blend aromatically for 1 week, then the aromatic blend plus a topical stick application for 1 week, and then, for 4 weeks, the aromatic blend, the topical stick, and took 2 capsules of the dietary supplement nightly.', 'interventionNames': ['Other: Lavender essential oil-based product system']}], 'interventions': [{'name': 'Lavender essential oil-based product system', 'type': 'OTHER', 'otherNames': ['doTERRA Serenity Sleep System'], 'description': 'Participants used the study products in a sequential, additive manner approximately 30-60 minutes before bedtime each night for 6 weeks. Usage consists of the following:\n\n* 20 drops of essential oil blend in approximately 250 mL of water in a diffuser, which operated for 8 hours at nighttime.\n* 3 x 6" swipes of the topical stick on the upper chest area, and 2 x 3" swipes on the inside of each wrist for topical application.\n* 2 capsules of the dietary supplement.\n\nParticipants used the essential oil blend alone for 1 week, then added the topical stick for another 1 week. Finally, participants used the essential oil blend, the topical stick, and the dietary supplement for four weeks.', 'armGroupLabels': ['Lavender essential oil-based product system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84062', 'city': 'Pleasant Grove', 'state': 'Utah', 'country': 'United States', 'facility': 'doTERRA International', 'geoPoint': {'lat': 40.36412, 'lon': -111.73854}}], 'overallOfficials': [{'name': 'Nicole Stevens, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'doTERRA International'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'dōTERRA International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}