protocolSection identificationModule nctId: NCT06299488, orgStudyIdInfo id: PS03, briefTitle: Combined Effects of Prunus Cerasus and Apocynum Venetum On Sleep and Anxiety in Adults With Insomnia, acronym: Sip2Sleep, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-05, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2023-07-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Lakshmi Nutraceuticals LLC, class: INDUSTRY, collaborators name: People Science, Inc., descriptionModule briefSummary: Lay Summary: This study is about the effect of using a unique formula called Sip2Sleep®, a product currently available on the market which is a combination of montmorency tart cherry extract and Venetron® (Apocynum venetum leaf extract) on sleep. The purpose of this study is to evaluate the effects of taking this combination product on various aspects of sleep. This study is being conducted by People Science, and is sponsored by Lakshmi Nutraceuticals, LLC. The information we gather will help inform how people may use Sip2Sleep® to affect the quality of sleep.Participants in this study will complete a number of surveys about their difficulties falling asleep and staying asleep (insomnia), their energy level during the day and health status regarding their quality of sleep.There are no major risks associated with this study., conditionsModule conditions: Insomnia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will complete a 5-week study consisting of screening assessments, baseline scales and surveys, objective digital measure, 2 weeks of product use (1 week on - 1 week off - 1 week on), scales and surveys, and end of study assessments and surveys. This is a remote observational study that will use the People Science app-based data collection platform Consumer Health Learning and Organizing Ecosystem (CHLOE) for study participants to report their assessments and collect objective sleep data from personal wearable devices. Participants will receive the study product during the baseline period. Demographic and medical history data will be collected for the study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: This study is not blinded. Participants consume the intervention on alternating weeks. All participants receive the intervention, enrollmentInfo count: 77, type: ACTUAL, armsInterventionsModule interventions name: Sip2Sleep: Montmorency Cherry and Apocynum Venetum, outcomesModule primaryOutcomes measure: Subjective Sleep Quality, secondaryOutcomes measure: Insomnia Sleep Index, secondaryOutcomes measure: Generalized Anxiety Disorder-7 (GAD-7), secondaryOutcomes measure: Subjective Alertness, otherOutcomes measure: Exploratory: Sleep Duration, otherOutcomes measure: Exploratory: Sleep Latency, otherOutcomes measure: Participant Satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: People Science Inc., city: West Hollywood, state: California, zip: 90069, country: United States, geoPoint lat: 34.09001, lon: -118.36174, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-03-24, uploadDate: 2024-02-28T17:22, filename: Prot_SAP_000.pdf, size: 436932, hasResults: False