SleepInTeNSSNCT03567343
Investigational Test of a New Sleep Supplement
A study testing Proprietary Spearmint Extract Blend in people with Sleep and Mood, run by University of Arizona at 1 site in United States.
Trial summary
This study seeks to observe the effects of a proprietary spearmint extract and green tea blend on sleep quality and duration. The study observes the effect of the supplement regarding sleep quality, and mental health. Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Mood, Cognitive Performance
- What is being tested?
- Proprietary Spearmint Extract Blend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2018to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be included in the study, patients must:
- Subject is a male or female, 22-50 years of age, inclusive.
- Subject is judged by the Investigator to be in general good health on the basis of medical history.
- Subject is a non-user of nicotine products for 6 months prior to screening.
- Subject's initial online screen reveals a score >5 on the PSQI.
- Subject has a BMI of 18.50-29.99 kg/m2, inclusive, at screening.
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- Subject is willing to maintain habitual diet and activity patterns throughout the study period, other than the study instructions given for caffeine, alcohol, and vigorous physical activity.
- Subject is willing to consume study product 30 minutes before bed throughout the study period.
- Subject will consume no more than 14 alcoholic drinks (12oz beer, 5oz wine, 1.5oz distilled spirits) per week while in the study, no more than 4 drinks on a single occasion, and no more than 1 alcoholic drink within 4 hours of bedtime.
- Subject will consume no more than 4 servings of caffeine substances per day (8oz coffee, 1oz espresso, 12oz caffeinated soda, 8oz energy drink) and no caffeine within 6 hours of bedtime.
- Subject will refrain from vigorous physical activity (causing sweating) within 2 hours of bedtime.
- Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- Subject has a history or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, chronic pain condition(s), or neurologic disorders.
- Subject has a history of diagnosed clinical depression in the prior 2 years of screening. This will be determined by self report at screening (PHQ9 scores indicating likely depression diagnosis (<=2 on items 1 or 2, plus <=2 on at least 5 other symptoms) will be exclusionary) and with the Mini International Neuropsychiatric Inventory assessed at the screening visit.
- Subject has an active infection or signs/symptoms of an infection. Clinic visits and/or sleep evaluations will be rescheduled to allow subject to be symptom-free of any type of systemic infection for at least 5 days.
- Subject has uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg) at screening.
- Subject has a known allergy or sensitivity to any ingredients in the study products.
- Subject is a heavy consumer of caffeinated beverages (>400 mg caffeine/d from caffeine-containing products) within 2 weeks of screening.
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- Subject diagnosed with a psychiatric disorder that would impair their ability to perform the study, such as a psychotic disorder, bipolar disorder, neurodevelopmental disorder, post-traumatic stress disorder, etc. The subject should not currently be experiencing a major depressive episode. Psychiatric history will be assessed at screening then reassessed at the screening visit; In addition, the Mini International Neuropsychiatric Inventory will be conducted at the screening visit.
- Subject has a history of use of psychotropic medications (including antidepressants, beta-blockers, and tranquilizers), stimulant medications, medical marijuana and/or narcotics within 4 weeks of screening.
- Subject has used sleep aid medications, supplements, and/or products (over-the-counter or prescription), including antihistamines, within 2 weeks of screening. If use has occurred a wash-out period can be conducted.
- Subject has a history of unconventional sleep patterns (e.g., night shift), chronic insomnia (defined as insomnia at least 3 d/week over the past month), a diagnosed sleep disorder (e.g., OSA), or a chronic medical condition that may impact energy/fatigue levels, in the judgment of the Investigator.
- Subject has a history of cancer within 5 years prior to screening except for non-melanoma skin cancer.
- Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to use of a medically approved form of contraception throughout the study period.
- Subject has a current or recent history (past 12 months of screening) or strong potential for drug or alcohol abuse. Alcohol abuse will be defined as > 14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 1.5 oz. hard liquor).
- Subject has been exposed to any non-registered drug product within 30 d prior to screening.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, might confound the interpretation of the study results, or put the person at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Dept of Psychiatry Research facilities
Tucson, Arizona, 85724
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of a Proprietary Spearmint Extract Blend, on Sleep in Healthy Men and Women
This study seeks to observe the effects of a proprietary spearmint extract and green tea blend on sleep quality and duration. The study observes the effect of the supplement regarding sleep quality, and mental health.
Read the detailed description
Sleep disturbance is common in adults and when it persists may result in chronic disease, excess health care utilization, mental disorders, health-risk behaviors, limitations of daily functioning, lost productivity, injury, and mortality (IOM 2006). An estimated 50-70 million adults in the United States have chronic sleep and wakefulness disorders (IOM 2006; Ram 2010) and many more adults report insufficient or deprived sleep. Data from 2014 indicates that approximately 35% of the US population is receiving insufficient sleep (Liu et al., 2016). This is alarming, since insufficient sleep is associated with cardiometabolic disease risk factors including weight gain, obesity, hypertension, diabetes, and inflammation (Grandner et al., 2016), as well as poor daytime functioning and many other outcomes (Grandner, 2017). Cognitive deficits are routinely seen in the laboratory, especially on the Psychomotor Vigilance Task (PVT) (Lim and Dinges, 2010). The National Institutes of Health suggests that adults aim for 7-8 h of sleep per night; however, approximately 28% of adults in the United States reported sleeping 6 h or less based on data from 2008 to 2010 (Schoenborn 2010).
A number of strategies are recommended to promote sleep quality and quantity, including a series of behavioral recommendations, such as keeping to a routine sleeping schedule, the timing of eating and physical activity in relation to bedtime, avoidance of stimulants, and maintaining a bedroom environment conducive to sleep (National Sleep Foundation 2015). Although, pharmacologic options are available to treat sleep disturbances, there is consumer interest in natural sleep remedies due to concerns with side effects, dependency, and the safety of prescription medications. The current study seeks observe the effects of a new proprietary blend containing spearmint and green tea extract. It will be the first randomized, double-blind, placebo controlled trial observing the effects of 30 days of 500 mg of a blend containing Spearmint extract and green tea on sleep when administered 30 minutes before bed. This study will utilize Fit-bit (San Francisco, California) (a tool whose use for evaluation of sleep is growing) for daily evaluation of sleep throughout the study in addition to polysomnography, considered by many researchers to be the gold standard for evaluation of sleep outcomes, at chosen timepoints.
- Conditions
- Sleep, Mood, Cognitive Performance
- Being tested
- Proprietary Spearmint Extract Blend, Control
- Keywords
- sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprietary Spearmint Extract BlendDietary supplement
Water extracted spearmint extract and green tea blend
ControlOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Proprietary Spearmint Extract Blend | Active comparator | Subjects randomized into the active treatment group will be asked to consume 500 mg/day of the Proprietary Spearmint Extract Blend blend by mouth every night 30 mins before bed, complete a sleep diary upon waking and wear a Fitbit Charge 2 device for sleep monitoring for 30 days.
A subset of this group will undergo 2 overnight polysomnography studies Receives: Dietary Supplement: Proprietary Spearmint Extract Blend |
| Control | Placebo comparator | Subjects randomized into the active treatment group will be asked to consume 500 mg/day of the excipient, microcrystalline cellulose by mouth every night 30 mins before bed, complete a sleep diary upon waking and wear a Fitbit Charge 2 device for sleep monitoring for 30 days.
A subset of this group will undergo 2 overnight polysomnography studies Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Diary- Sleep Latency
Time it takes to fall asleep after the lights have been turned off in minutes (Weekly averages)
Measured: Change from baseline after 30 days supplementation
Fitbit - Rapid Eye Movement (REM) Sleep
Change in Rapid Eye Movement (REM) Sleep in minutes (Weekly averages)
Measured: Change from baseline after 30 days supplementation
Secondary outcomes (15)
Sleep Diary -Total Sleep Time
Total Sleep Time in minutes
Measured: Change from baseline after 30 days supplementation
Sleep Diary-Wake After Sleep Onset
Number of awakenings after sleep onset
Measured: Change from baseline after 30 days supplementation
Sleep Diary- Sleep Efficiency
ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)
Measured: Change from baseline after 30 days supplementation
Sleep Diary - Objective Sleep Quality
Sleep Quality (units on a visual analogue scale from 0-10, 0 being the worst outcome, 10 being the best outcome)
Measured: Change from baseline after 30 days supplementation
Fitbit- Light Sleep
Change in Light Sleep in minutes (Weekly averages)
Measured: Change from baseline after 30 days supplementation
Fitbit - Total Sleep Time
Total sleep time in minutes
Measured: Change from baseline after 30 days supplementation
Fitbit- Sleep Efficiency
ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed (percentage)
Measured: Change from baseline after 30 days supplementation
Fitbit- Deep Sleep
Change in Deep Sleep in minutes (Weekly averages)
Measured: Change from baseline after 30 days supplementation
The Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI): Total Score. Self-report rating scale assessing the severity of insomnia symptoms. Range 0-28 with higher scores indicating a more severe insomnia.
Measured: Change from baseline after 30 days supplementation
Sustained Attention
Attentional lapses (failure to respond to stimuli within 500 ms) using the psychomotor vigilance test (PVT)
Measured: Change from baseline after 30 days supplementation
Profile of Mood States (POMS)
Profile of Mood States (POMS): Mood scores. The Profile of Mood States (POMS) is a psychological rating scale used to assess transient, distinct mood states. 65 adjectives rated on 5-point scale 0= not at all; 1=a little; 2=moderately; 3=quite a bit; 4=extremely. Factor analysis: 6 subscales tension-anxiety (9 items, score range: 0-36) depression (15 items, range 0-60) anger-hostility (12 items, range 0-48) vigor-activity (8 items, range 0-32) fatigue (7 items, range 0-28) confusion-bewilderment (7 items, range 0-28) Total mood disturbance (TMD) (range 0-200): TMD = (Tension + Depression + Anger + Fatigue + Confusion) - Vigour
Measured: Change from baseline after 30 days supplementation
Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS): Total Score. The PSS is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances.Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4 - "Very often." Scores range from 0-56 higher scores indicate greater perceived stress.
Measured: Change from baseline after 30 days supplementation
The Center for Epidemiological Studies Depression Scale (CESD)
The Center for Epidemiological Studies Depression scale (CESD) Total score. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Measured: Change from baseline after 30 days supplementation
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI): Total Score. The PSQI is a validated self-rating instrument assessing aspects of sleep quality.Minimum score 0 (better); maximum score 21 (worse) < or = 5 associated with good sleep quality; > 5 associated with poor sleep quality.
Measured: Change from baseline after 30 days supplementation
Sustained Attention
Mean reaction time to stimuli using the psychomotor vigilance test (PVT)
Measured: Change from baseline after 30 days supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start18 May 2018
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Kemin Foods LC
- Responsible party
- Principal investigator, MICHAEL A GRANDNER, University of Arizona
- Investigators
- Michael Grandner, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567343
- Sponsor's protocol ID
- 1803377507
- Acronym
- InTeNSS
- Status last verified
- Feb 2024
- First submitted
- 16 May 2018
- Last updated
- 18 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tubbs AS, Kennedy KER, Alfonso-Miller P, Wills CCA, Grandner MA. A Randomized, Double-Blind, Placebo-Controlled Trial of a Polyphenol Botanical Blend on Sleep and Daytime Functioning. Int J Environ Res Public Health. 2021 Mar 16;18(6):3044. doi: 10.3390/ijerph18063044.
PubMed 33809544
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of a Proprietary Spearmint Extract Blend, on Sleep in Healthy Men and Women
- ClinicalTrials.gov ID
- NCT03567343
- Acronym / sponsor ID
- InTeNSS / 1803377507
- Conditions
- Sleep, Mood, Cognitive Performance
- Keywords
- sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Kemin Foods LC
- Study start
- 18 May 2018 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Posted 18 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to observe the effects of a proprietary spearmint extract and green tea blend on sleep quality and duration. The study observes the effect of the supplement regarding sleep quality, and mental health.
Detailed description
Sleep disturbance is common in adults and when it persists may result in chronic disease, excess health care utilization, mental disorders, health-risk behaviors, limitations of daily functioning, lost productivity, injury, and mortality (IOM 2006). An estimated 50-70 million adults in the United States have chronic sleep and wakefulness disorders (IOM 2006; Ram 2010) and many more adults report insufficient or deprived sleep. Data from 2014 indicates that approximately 35% of the US population is receiving insufficient sleep (Liu et al., 2016). This is alarming, since insufficient sleep is associated with cardiometabolic disease risk factors including weight gain, obesity, hypertension, diabetes, and inflammation (Grandner et al., 2016), as well as poor daytime functioning and many other outcomes (Grandner, 2017). Cognitive deficits are routinely seen in the laboratory, especially on the Psychomotor Vigilance Task (PVT) (Lim and Dinges, 2010). The National Institutes of Health suggests that adults aim for 7-8 h of sleep per night; however, approximately 28% of adults in the United States reported sleeping 6 h or less based on data from 2008 to 2010 (Schoenborn 2010).
A number of strategies are recommended to promote sleep quality and quantity, including a series of behavioral recommendations, such as keeping to a routine sleeping schedule, the timing of eating and physical activity in relation to bedtime, avoidance of stimulants, and maintaining a bedroom environment conducive to sleep (National Sleep Foundation 2015). Although, pharmacologic options are available to treat sleep disturbances, there is consumer interest in natural sleep remedies due to concerns with side effects, dependency, and the safety of prescription medications. The current study seeks observe the effects of a new proprietary blend containing spearmint and green tea extract. It will be the first randomized, double-blind, placebo controlled trial observing the effects of 30 days of 500 mg of a blend containing Spearmint extract and green tea on sleep when administered 30 minutes before bed. This study will utilize Fit-bit (San Francisco, California) (a tool whose use for evaluation of sleep is growing) for daily evaluation of sleep throughout the study in addition to polysomnography, considered by many researchers to be the gold standard for evaluation of sleep outcomes, at chosen timepoints.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprietary Spearmint Extract Blend | Active comparator | Dietary Supplement: Proprietary Spearmint Extract BlendSubjects randomized into the active treatment group will be asked to consume 500 mg/day of the Proprietary Spearmint Extract Blend blend by mouth every night 30 mins before bed, complete a sleep diary upon waking and wear a Fitbit Charge 2 device for sleep monitoring for 30 days. A subset of this group will undergo 2 overnight polysomnography studies |
| Control | Placebo comparator | Other: ControlSubjects randomized into the active treatment group will be asked to consume 500 mg/day of the excipient, microcrystalline cellulose by mouth every night 30 mins before bed, complete a sleep diary upon waking and wear a Fitbit Charge 2 device for sleep monitoring for 30 days. A subset of this group will undergo 2 overnight polysomnography studies |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subject is a male or female, 22-50 years of age, inclusive.
- Subject is judged by the Investigator to be in general good health on the basis of medical history.
- Subject is a non-user of nicotine products for 6 months prior to screening.
- Subject's initial online screen reveals a score >5 on the PSQI.
- Subject has a BMI of 18.50-29.99 kg/m2, inclusive, at screening.
Key exclusion criteria (15 listed)
- Subject has a history or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, chronic pain condition(s), or neurologic disorders.
- Subject has a history of diagnosed clinical depression in the prior 2 years of screening. This will be determined by self report at screening (PHQ9 scores indicating likely depression diagnosis (<=2 on items 1 or 2, plus <=2 on at least 5 other symptoms) will be exclusionary) and with the Mini International Neuropsychiatric Inventory assessed at the screening visit.
- Subject has an active infection or signs/symptoms of an infection. Clinic visits and/or sleep evaluations will be rescheduled to allow subject to be symptom-free of any type of systemic infection for at least 5 days.
- Subject has uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg) at screening.
- Subject has a known allergy or sensitivity to any ingredients in the study products.
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 |
|---|---|---|
| Proprietary Spearmint Extract BlendWater extracted spearmint extract and green tea blend | Dietary supplement | Proprietary Spearmint Extract Blend |
| ControlPlacebo | Other | Control |
Primary outcome
Sleep Diary- Sleep Latency
Time frame: Change from baseline after 30 days supplementation
Time it takes to fall asleep after the lights have been turned off in minutes (Weekly averages)
Fitbit - Rapid Eye Movement (REM) Sleep
Time frame: Change from baseline after 30 days supplementation
Change in Rapid Eye Movement (REM) Sleep in minutes (Weekly averages)
15 secondary outcomes
Sleep Diary -Total Sleep Time
Time frame: Change from baseline after 30 days supplementation
Sleep Diary-Wake After Sleep Onset
Time frame: Change from baseline after 30 days supplementation
Sleep Diary- Sleep Efficiency
Time frame: Change from baseline after 30 days supplementation
Sleep Diary - Objective Sleep Quality
Time frame: Change from baseline after 30 days supplementation
Fitbit- Light Sleep
Time frame: Change from baseline after 30 days supplementation
Fitbit - Total Sleep Time
Time frame: Change from baseline after 30 days supplementation
Fitbit- Sleep Efficiency
Time frame: Change from baseline after 30 days supplementation
Fitbit- Deep Sleep
Time frame: Change from baseline after 30 days supplementation
The Insomnia Severity Index (ISI)
Time frame: Change from baseline after 30 days supplementation
Sustained Attention
Time frame: Change from baseline after 30 days supplementation
Profile of Mood States (POMS)
Time frame: Change from baseline after 30 days supplementation
Perceived Stress Scale (PSS)
Time frame: Change from baseline after 30 days supplementation
The Center for Epidemiological Studies Depression Scale (CESD)
Time frame: Change from baseline after 30 days supplementation
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline after 30 days supplementation
Sustained Attention
Time frame: Change from baseline after 30 days supplementation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33809544Tubbs AS, Kennedy KER, Alfonso-Miller P, Wills CCA, Grandner MA. A Randomized, Double-Blind, Placebo-Controlled Trial of a Polyphenol Botanical Blend on Sleep and Daytime Functioning. Int J Environ Res Public Health. 2021 Mar 16;18(6):3044. doi: 10.3390/ijerph18063044.
- Individual participant dataSharing planned: No
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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.
Michael Grandner, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprietary Spearmint Extract Blend in people with Sleep and Mood, run by University of Arizona 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 15 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 18 Jul 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 18 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sleep Diary- Sleep Latency (time frame: Change from baseline after 30 days supplementation). The study lists 2 primary outcomes in all. 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 NCT03567343, which also lists 1 linked publication.
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 18 Jul 2024.