Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299488
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2024-02-28
Brief Title:
Combined Effects of Prunus Cerasus and Apocynum Venetum On Sleep and Anxiety in Adults With Insomnia
Sponsor:
Lakshmi Nutraceuticals LLC
Organization:
Lakshmi Nutraceuticals LLC
Study Overview
Official Title:
Combined Effects of Prunus Cerasus Montmorency Tart Cherry and Apocynum Venetum Venetron On Sleep and Anxiety in Adults With Insomnia
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Sip2Sleep
Brief Summary:
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
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
Detailed Description:
The rationale for this study is to determine the effect of a consumer-grade unique formula called Sip2Sleep which is a combination of Montmorency tart cherry extract and Venetron a patented purified powdered extract derived from the Rafuma leaf Apocynum venetum on sleep disturbance in adults Because this product is currently available in the OTC market across the United States a consumer-driven decentralized observational clinical research study is well-suited for examining the effect of this formulation on sleep
Sleep disturbance is highly prevalent and impacted by many interdependent variables We will examine self-reported sleep disturbance in a broad age-range of adults who have chosen to use this product The study will incorporate participant reported outcome questionnaires daily surveys and the participants personal health tracking wearable device eg Apple Watch Fitbit Smartwatch etc to engage the participant in their sleep health and explore objective digital outcome measures of sleep An important feature of this consumer-driven study design is to help individual consumers observe the effects of this product on their own sleep patterns during the study itself There is no doctor-patient relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures Findings from this study will contribute knowledge toward the design of future sleep research studies the improvement of the Sip2Sleep product formulation and may help inform clinical recommendations for adults interested in using alternative products for sleep
The following self-reporting measures are used in order to evaluate the effect of Sip2Sleep in adults with self-reported sleep disturbance
Surveys to reflect sleep quality sleep latency total sleep duration and level of alertness during the day to be distributed daily Sleep quality and level of alertness during the day will be evaluated with a single 10-point visual analogue scale VAS and objective sleep data reflecting sleep latency and total sleep duration will be collected from personal wearable devices
Insomnia Sleep Index ISI is a brief self-report instrument measuring the patients perception of both nocturnal and diurnal symptoms of insomnia during the past two weeks The ISI comprises seven items assessing the perceived severity of difficulties initiating sleep staying asleep and early morning awakenings satisfaction with current sleep pattern interference with daily functioning noticeability of impairment attributed to the sleep problem and degree of distress or concern caused by the sleep problem Each item is rated on a five-point scale and the total score indicates the severity of insomnia with a range of possible scores from 0-28 A score higher than 14 has been indicated to be the optimal cut-off for insomnia as a disorder The ISI has been widely used in clinical and research settings as it is brief and easy to administer and can provide valuable information for diagnosis and treatment planning Research has found that the ISI is sensitive in detecting changes in the patients perception of treatment outcome and a good degree of convergence exists between the patient and the clinicians evaluation of insomnia severity1314 Generalized Anxiety Disorder-7 GAD-7 is a self-reported anxiety survey utilized in primary care consisting of a 7-item anxiety scale The instrument is well supported to use in a general population and normative data can be used to compare a subjects GAD-7 score with those determined from a general population reference group with evidence of significant reliability and validity with congruent agreement in self-reported and interviewer-administered versions of the scale GAD and Depression symptoms frequently occur together but previous studies have supported via factor analysis that this measure can detect GAD and depression as distinct dimensions15 This measure will be used in combination with other scales to observe self-reported effects on sleep disturbances and insomnia such as anxiety or other psychiatric disorders
Sleep disturbance is highly prevalent and impacted by many interdependent variables We will examine self-reported sleep disturbance in a broad age-range of adults who have chosen to use this product The study will incorporate participant reported outcome questionnaires daily surveys and the participants personal health tracking wearable device eg Apple Watch Fitbit Smartwatch etc to engage the participant in their sleep health and explore objective digital outcome measures of sleep An important feature of this consumer-driven study design is to help individual consumers observe the effects of this product on their own sleep patterns during the study itself There is no doctor-patient relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures Findings from this study will contribute knowledge toward the design of future sleep research studies the improvement of the Sip2Sleep product formulation and may help inform clinical recommendations for adults interested in using alternative products for sleep
The following self-reporting measures are used in order to evaluate the effect of Sip2Sleep in adults with self-reported sleep disturbance
Surveys to reflect sleep quality sleep latency total sleep duration and level of alertness during the day to be distributed daily Sleep quality and level of alertness during the day will be evaluated with a single 10-point visual analogue scale VAS and objective sleep data reflecting sleep latency and total sleep duration will be collected from personal wearable devices
Insomnia Sleep Index ISI is a brief self-report instrument measuring the patients perception of both nocturnal and diurnal symptoms of insomnia during the past two weeks The ISI comprises seven items assessing the perceived severity of difficulties initiating sleep staying asleep and early morning awakenings satisfaction with current sleep pattern interference with daily functioning noticeability of impairment attributed to the sleep problem and degree of distress or concern caused by the sleep problem Each item is rated on a five-point scale and the total score indicates the severity of insomnia with a range of possible scores from 0-28 A score higher than 14 has been indicated to be the optimal cut-off for insomnia as a disorder The ISI has been widely used in clinical and research settings as it is brief and easy to administer and can provide valuable information for diagnosis and treatment planning Research has found that the ISI is sensitive in detecting changes in the patients perception of treatment outcome and a good degree of convergence exists between the patient and the clinicians evaluation of insomnia severity1314 Generalized Anxiety Disorder-7 GAD-7 is a self-reported anxiety survey utilized in primary care consisting of a 7-item anxiety scale The instrument is well supported to use in a general population and normative data can be used to compare a subjects GAD-7 score with those determined from a general population reference group with evidence of significant reliability and validity with congruent agreement in self-reported and interviewer-administered versions of the scale GAD and Depression symptoms frequently occur together but previous studies have supported via factor analysis that this measure can detect GAD and depression as distinct dimensions15 This measure will be used in combination with other scales to observe self-reported effects on sleep disturbances and insomnia such as anxiety or other psychiatric disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None