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Investigational Test of a New Sleep Supplement (InTeNSS Trial)
N/A
Waitlist Available
Led By Michael Grandner, PhD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline after 30 days supplementation
Summary
This trial tests a special mix of spearmint and green tea extracts on adults who have trouble sleeping. The natural compounds in these plants might help improve sleep quality and duration.
Eligible Conditions
- Cognitive Functioning
- Depression
- Sleep
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline after 30 days supplementation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline after 30 days supplementation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fitbit - Rapid Eye Movement (REM) Sleep
Sleep Diary- Sleep Latency
Secondary study objectives
Fitbit - Total Sleep Time
Fitbit- Deep Sleep
Fitbit- Light Sleep
+11 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Proprietary Spearmint Extract BlendActive Control1 Intervention
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
Group II: ControlPlacebo Group1 Intervention
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
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Who is running the clinical trial?
Kemin Foods LCIndustry Sponsor
8 Previous Clinical Trials
467 Total Patients Enrolled
University of ArizonaLead Sponsor
539 Previous Clinical Trials
161,070 Total Patients Enrolled
21 Trials studying Depression
3,224 Patients Enrolled for Depression
Michael Grandner, PhDPrincipal InvestigatorUniversity of Arizona
1 Previous Clinical Trials
200 Total Patients Enrolled