InsomniaSip2SleepNCT06299488
Combined Effects of Prunus Cerasus and Apocynum Venetum On Sleep and Anxiety in Adults With Insomnia
A study testing Sip2Sleep: Montmorency Cherry and Apocynum Venetum in people with Insomnia, run by Lakshmi Nutraceuticals LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Sip2Sleep: Montmorency Cherry and Apocynum Venetum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2023to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Has self-reported sleep disturbance
- Insomnia Severity Index (ISI) score of > 15 at screening
- Interested in understanding more about the quality of their sleep and chose to use the Sip2Sleep product for sleep
- Willingness to do a minimum of 1 week wash out of current OTC or other products for sleep (e.g. melatonin, anticholinergics)
- Willingness to do a minimum of 1 week wash out of any cannabis products
Show all 12Show fewer
- Able to receive shipment of the product at an address within the United States If taking prescription hypnotics (e.g. zolpidem, zaleplon, benzodiazepines) or other class of medication for sleep, must be on a stable dose for at least 4 weeks.
- Able to read and understand English
- Able to use a personal smartphone
- Has and is able to use a personal health tracking wearable device (e.g., Apple Watch, Fitbit Smartwatch, Oura Ring, etc.)
- Able to understand and provide informed consent
- Able to complete study assessments over 5 weeks
Who cannot join
- Research participants who have no computer, smartphone, and internet access and/or do not use a computer or smartphone
- The following concomitant therapies are excluded:
- Participants taking daily prescription medication for sleep (for example, prescription hypnotics like zolpidem, zaleplon, benzodiazepines) not on a stable dose for at least 4 weeks
- Participants receiving Cognitive Behavioral Therapy for Insomnia (CBTi)
- Participants receiving any investigational therapies or treatments
- Other Illnesses or Conditions: Participants who have the following co-morbidities are excluded:
Show all 13Show fewer
- Confirmed diagnoses of the following sleep disorders: Narcolepsy, Restless Leg Syndrome, Circadian Rhythm Disorders
- Confirmed diagnosis of Sleep Apnea that is untreated or not well controlled
- Current or prior psychotic disorder
- Current or prior Substance Abuse Disorder
- Current or prior cardiac dysrhythmias (for example, atrial fibrillation, supraventricular tachycardia)
- Currently pregnant, planning to become pregnant in the next 1 month, or breastfeeding
- Allergies or adverse reactions (for example, anxiety) to Montmorency tart cherry extract and/or Venetron®
Trial locations and contacts
1 site in 1 country.
United States1 site
People Science Inc.
West Hollywood, California, 90069
About this study
Official title: Combined Effects of Prunus Cerasus (Montmorency Tart Cherry) and Apocynum Venetum (Venetron®) On Sleep and Anxiety in Adults With Insomnia
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.
Read the 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 (e.g. 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 patient's 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 patient's perception of treatment outcome, and a good degree of convergence exists between the patient and the clinician's evaluation of insomnia severity.13,14 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 subject's 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 dimensions.15 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.
- Conditions
- Insomnia
- Being tested
- Sip2Sleep: Montmorency Cherry and Apocynum Venetum
- Keywords
- Sleep, Herbal, Sleep Aid
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sip2Sleep: Montmorency Cherry and Apocynum VenetumOther
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Montmorency Cherry + Apocynum Venetum | Experimental | Sip2Sleep® is a proprietary formula of Montmorency tart cherry extract and Venetron®, a purified, powdered extract derived from Apocynum Venetum. Recommended dose is ¼ teaspoon which contains 553 mg (1:5 fruit extract) of Montmorency tart cherry and 25mg of Venetron® leaf extract. The compound was prepared as an oral dropper, consumed alone or in water 30-60 minutes prior to bedtime. The study was conducted over a period of four weeks, consisting of two weeks without intervention and two weeks with intervention as follows: (1 week off (baseline) - 1 week on - 1 week off - 1 week on) for each participant Receives: Other: Sip2Sleep: Montmorency Cherry and Apocynum Venetum |
| No intervention: Typical Sleep Routine | No intervention | The study was conducted over a period of four weeks, consisting of two weeks without intervention and two weeks with intervention (ABAB) as follows: (1 week off (baseline) - 1 week on - 1 week off - 1 week on) for each participant. Participants did not consume any intervention or placebo during this time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Sleep Quality
Change in average sleep quality score by 1 point as measured by daily 10-point visual analogue rating scale (VAS) from baseline and 1 week of no product use
Measured: 14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.
Secondary outcomes (3)
Insomnia Sleep Index
Change in Insomnia Sleep Index (ISI) by at least 4 points or more from baseline and 1 week of no product use
Measured: 14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.
Generalized Anxiety Disorder-7 (GAD-7)
Change in Generalized Anxiety Disorder-7 (GAD-7) by 4 points or more from baseline and 1 week of no product use
Measured: 14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.
Subjective Alertness
Change in average level of alertness during the daytime score by 1 point as measured by daily 10-point visual analogue rating scale (VAS)
Measured: 14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start5 Apr 2023
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakshmi Nutraceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
- Investigators
- Noah Craft, MD/PhD, Principal investigator, People Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299488
- Sponsor's protocol ID
- PS03
- Acronym
- Sip2Sleep
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foley L. Sleep Foundation: Insomnia.
Losso JN, Finley JW, Karki N, Liu AG, Prudente A, Tipton R, Yu Y, Greenway FL. Pilot Study of the Tart Cherry Juice for the Treatment of Insomnia and Investigation of Mechanisms. Am J Ther. 2018 Mar/Apr;25(2):e194-e201. doi: 10.1097/MJT.0000000000000584.
PubMed 28901958Pigeon WR, Carr M, Gorman C, Perlis ML. Effects of a tart cherry juice beverage on the sleep of older adults with insomnia: a pilot study. J Med Food. 2010 Jun;13(3):579-83. doi: 10.1089/jmf.2009.0096.
PubMed 20438325Grundmann O, Nakajima J, Seo S, Butterweck V. Anti-anxiety effects of Apocynum venetum L. in the elevated plus maze test. J Ethnopharmacol. 2007 Apr 4;110(3):406-11. doi: 10.1016/j.jep.2006.09.035. Epub 2006 Oct 13.
PubMed 17101250Yang, J. et al. 2009. Safety study of Apocynum venetum extract in healthy adults. Journal of Nutritional Food, no. 12:1-9.
Vissiennon C, Nieber K, Kelber O, Butterweck V. Route of administration determines the anxiolytic activity of the flavonols kaempferol, quercetin and myricetin--are they prodrugs? J Nutr Biochem. 2012 Jul;23(7):733-40. doi: 10.1016/j.jnutbio.2011.03.017. Epub 2011 Aug 12.
PubMed 21840194
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Prunus Cerasus (Montmorency Tart Cherry) and Apocynum Venetum (Venetron®) On Sleep and Anxiety in Adults With Insomnia
- ClinicalTrials.gov ID
- NCT06299488
- Acronym / sponsor ID
- Sip2Sleep / PS03
- Conditions
- Insomnia
- Keywords
- Sleep, Herbal, Sleep Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Lakshmi Nutraceuticals LLCIndustry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (e.g. 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 patient's 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 patient's perception of treatment outcome, and a good degree of convergence exists between the patient and the clinician's evaluation of insomnia severity.13,14 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 subject's 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 dimensions.15 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention: Montmorency Cherry + Apocynum Venetum | Experimental | Other: Sip2Sleep: Montmorency Cherry and Apocynum VenetumSip2Sleep® is a proprietary formula of Montmorency tart cherry extract and Venetron®, a purified, powdered extract derived from Apocynum Venetum. Recommended dose is ¼ teaspoon which contains 553 mg (1:5 fruit extract) of Montmorency tart cherry and 25mg of Venetron® leaf extract. The compound was prepared as an oral dropper, consumed alone or in water 30-60 minutes prior to bedtime. The study was conducted over a period of four weeks, consisting of two weeks without intervention and two weeks with intervention as follows: (1 week off (baseline) - 1 week on - 1 week off - 1 week on) for each participant |
| No intervention: Typical Sleep Routine | No intervention | –The study was conducted over a period of four weeks, consisting of two weeks without intervention and two weeks with intervention (ABAB) as follows: (1 week off (baseline) - 1 week on - 1 week off - 1 week on) for each participant. Participants did not consume any intervention or placebo during this time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age > 18 years old
- Has self-reported sleep disturbance
- Insomnia Severity Index (ISI) score of > 15 at screening
- Interested in understanding more about the quality of their sleep and chose to use the Sip2Sleep product for sleep
- Willingness to do a minimum of 1 week wash out of current OTC or other products for sleep (e.g. melatonin, anticholinergics)
Key exclusion criteria (13 listed)
- Research participants who have no computer, smartphone, and internet access and/or do not use a computer or smartphone
- The following concomitant therapies are excluded:
- Participants taking daily prescription medication for sleep (for example, prescription hypnotics like zolpidem, zaleplon, benzodiazepines) not on a stable dose for at least 4 weeks
- Participants receiving Cognitive Behavioral Therapy for Insomnia (CBTi)
- Participants receiving any investigational therapies or treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sip2Sleep: Montmorency Cherry and Apocynum VenetumSee arm description | Other | Intervention: Montmorency Cherry + Apocynum Venetum |
Primary outcome
Subjective Sleep Quality
Time frame: 14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.
Change in average sleep quality score by 1 point as measured by daily 10-point visual analogue rating scale (VAS) from baseline and 1 week of no product use
3 secondary outcomes
Insomnia Sleep Index
Time frame: 14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.
Subjective Alertness
Time frame: 14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- BackgroundFoley L. Sleep Foundation: Insomnia.
- Background: PubMed 28901958Losso JN, Finley JW, Karki N, Liu AG, Prudente A, Tipton R, Yu Y, Greenway FL. Pilot Study of the Tart Cherry Juice for the Treatment of Insomnia and Investigation of Mechanisms. Am J Ther. 2018 Mar/Apr;25(2):e194-e201. doi: 10.1097/MJT.0000000000000584.
- Background: PubMed 20438325Pigeon WR, Carr M, Gorman C, Perlis ML. Effects of a tart cherry juice beverage on the sleep of older adults with insomnia: a pilot study. J Med Food. 2010 Jun;13(3):579-83. doi: 10.1089/jmf.2009.0096.
- Background: PubMed 17101250Grundmann O, Nakajima J, Seo S, Butterweck V. Anti-anxiety effects of Apocynum venetum L. in the elevated plus maze test. J Ethnopharmacol. 2007 Apr 4;110(3):406-11. doi: 10.1016/j.jep.2006.09.035. Epub 2006 Oct 13.
- BackgroundYang, J. et al. 2009. Safety study of Apocynum venetum extract in healthy adults. Journal of Nutritional Food, no. 12:1-9.
- Background: PubMed 21840194Vissiennon C, Nieber K, Kelber O, Butterweck V. Route of administration determines the anxiolytic activity of the flavonols kaempferol, quercetin and myricetin--are they prodrugs? J Nutr Biochem. 2012 Jul;23(7):733-40. doi: 10.1016/j.jnutbio.2011.03.017. Epub 2011 Aug 12.
- Individual participant dataSharing planned: No
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Craft, MD/PhD principal investigator
People Science, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sip2Sleep: Montmorency Cherry and Apocynum Venetum in people with Insomnia, run by Lakshmi Nutraceuticals LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Sleep Quality (time frame: 14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06299488, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.