Novel Formulation for Sleep Among People With Poor Sleep Quality
NCT ID: NCT05609890
Last Updated: 2023-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2023-01-15
2023-07-31
Brief Summary
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Detailed Description
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This is a randomized, doble-blind, placebo controlled clinical trial. The primary outcome is sleep efficiency. A sample size of 60 participants is needed for having a power of 95%, a one type error of 5% and a minimal difference of at least 2.8% between groups in the primary outcome. As we estimate a loss to follow-up of 10%, 66 participants will be enrolled. The main inclusion criteria will be having a poor sleep quality demonstrated as having a Pittsburgh Sleep Quality Index (PSQI) equal to or greater than five. In a random allocation design, one group of participants will receive the active intervention and the other one will receive a placebo with similar organoleptic features. The study will be executed in three main phases: First, a run-in phase where eligible participants will receive the active intervention during one week, and only those with adherence 85% or greater continue to the next phase. Second, a wash-out phase in which participants will not receive any intervention but actigraphic data will be collected. Finally, in the third (intervention) phase participants will be randomized following a minimization algorithm to the active or placebo group, to be taken for six weeks. Subjective and objective sleep variables will be measured at the beginning and the end of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active intervention
A formulation made of natural components. Each sachet contains saffron, tea extract, lemon balm and valerian.
Supplement
Supplement: a mixture of saffron, tea extract, lemon balm and valerian.
Dose: The participant will take one sachet every day, one hour before going to bed, for six weeks.
Placebo
Placebo sachet will contain inert excipient.
Placebo
Placebo sachet
Dose: The participant will take one sachet everyday, one hour before going to bed, for six weeks.
Interventions
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Supplement
Supplement: a mixture of saffron, tea extract, lemon balm and valerian.
Dose: The participant will take one sachet every day, one hour before going to bed, for six weeks.
Placebo
Placebo sachet
Dose: The participant will take one sachet everyday, one hour before going to bed, for six weeks.
Eligibility Criteria
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Inclusion Criteria
* PSQI \>=5
* Provision of informed consent
* Adherence \>= 85%
Exclusion Criteria
* Taking any specific pharmacologic treatment to improve sleep or planning to take it in the next two months
* Medical history of generalized anxiety disorder, depression or other serious psychiatric / neurological disease
* Uncontrolled hypothyroidism
* Medical history of deficit or excess of corticosteroids (Cushing syndrome, Addison syndrome, chronic steroid use)
* Alcohol intake (more than two standard drinks/day, on average)
* Caffeine intake more than 400 mg per day, on average
* Frequent sleep deprivation over the last two months
* Women with desire to become pregnant
18 Years
ALL
Yes
Sponsors
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Team Foods Colombia S.A.
INDUSTRY
Carlos O Mendivil
OTHER
Responsible Party
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Carlos O Mendivil
Professor of Medicine
Locations
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Universidad de los Andes, School of Medicine
Bogotá, Bogota D.C., Colombia
Countries
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References
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Ruiz AJ, Sepulveda MA, Martinez PH, Munoz MC, Mendoza LO, Centanaro OP, Carrasco LF, Garcia JC. Prevalence of sleep complaints in Colombia at different altitudes. Sleep Sci. 2016 Apr-Jun;9(2):100-5. doi: 10.1016/j.slsci.2016.05.008. Epub 2016 Jun 4.
Ong JL, Lau T, Massar SAA, Chong ZT, Ng BKL, Koek D, Zhao W, Yeo BTT, Cheong K, Chee MWL. COVID-19-related mobility reduction: heterogenous effects on sleep and physical activity rhythms. Sleep. 2021 Feb 12;44(2):zsaa179. doi: 10.1093/sleep/zsaa179.
Medic G, Wille M, Hemels ME. Short- and long-term health consequences of sleep disruption. Nat Sci Sleep. 2017 May 19;9:151-161. doi: 10.2147/NSS.S134864. eCollection 2017.
Meerlo P, Sgoifo A, Suchecki D. Restricted and disrupted sleep: effects on autonomic function, neuroendocrine stress systems and stress responsivity. Sleep Med Rev. 2008 Jun;12(3):197-210. doi: 10.1016/j.smrv.2007.07.007. Epub 2008 Jan 25.
McCoy JG, Strecker RE. The cognitive cost of sleep lost. Neurobiol Learn Mem. 2011 Nov;96(4):564-82. doi: 10.1016/j.nlm.2011.07.004. Epub 2011 Aug 22.
Meng L, Zheng Y, Hui R. The relationship of sleep duration and insomnia to risk of hypertension incidence: a meta-analysis of prospective cohort studies. Hypertens Res. 2013 Nov;36(11):985-95. doi: 10.1038/hr.2013.70. Epub 2013 Sep 5.
Pan XL, Nie L, Zhao SY, Zhang XB, Zhang S, Su ZF. The Association Between Insomnia and Atherosclerosis: A Brief Report. Nat Sci Sleep. 2022 Mar 15;14:443-448. doi: 10.2147/NSS.S336318. eCollection 2022.
Hargens TA, Kaleth AS, Edwards ES, Butner KL. Association between sleep disorders, obesity, and exercise: a review. Nat Sci Sleep. 2013 Mar 1;5:27-35. doi: 10.2147/NSS.S34838. Print 2013.
Knutson KL. Does inadequate sleep play a role in vulnerability to obesity? Am J Hum Biol. 2012 May-Jun;24(3):361-71. doi: 10.1002/ajhb.22219. Epub 2012 Jan 24.
Schipper SBJ, Van Veen MM, Elders PJM, van Straten A, Van Der Werf YD, Knutson KL, Rutters F. Sleep disorders in people with type 2 diabetes and associated health outcomes: a review of the literature. Diabetologia. 2021 Nov;64(11):2367-2377. doi: 10.1007/s00125-021-05541-0. Epub 2021 Aug 16.
Lin CL, Chien WC, Chung CH, Wu FL. Risk of type 2 diabetes in patients with insomnia: A population-based historical cohort study. Diabetes Metab Res Rev. 2018 Jan;34(1). doi: 10.1002/dmrr.2930. Epub 2017 Oct 4.
Aggarwal S, Loomba RS, Arora RR, Molnar J. Associations between sleep duration and prevalence of cardiovascular events. Clin Cardiol. 2013 Nov;36(11):671-6. doi: 10.1002/clc.22160. Epub 2013 Oct 1.
Choi Y, Choi JW. Association of sleep disturbance with risk of cardiovascular disease and all-cause mortality in patients with new-onset type 2 diabetes: data from the Korean NHIS-HEALS. Cardiovasc Diabetol. 2020 May 13;19(1):61. doi: 10.1186/s12933-020-01032-5.
Mogavero MP, DelRosso LM, Fanfulla F, Bruni O, Ferri R. Sleep disorders and cancer: State of the art and future perspectives. Sleep Med Rev. 2021 Apr;56:101409. doi: 10.1016/j.smrv.2020.101409. Epub 2020 Nov 28.
Rod NH, Vahtera J, Westerlund H, Kivimaki M, Zins M, Goldberg M, Lange T. Sleep disturbances and cause-specific mortality: Results from the GAZEL cohort study. Am J Epidemiol. 2011 Feb 1;173(3):300-9. doi: 10.1093/aje/kwq371. Epub 2010 Dec 30.
Chattu VK, Manzar MD, Kumary S, Burman D, Spence DW, Pandi-Perumal SR. The Global Problem of Insufficient Sleep and Its Serious Public Health Implications. Healthcare (Basel). 2018 Dec 20;7(1):1. doi: 10.3390/healthcare7010001.
Related Links
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Filip I, Tidman M, Saheba N, Bennet H, Wick B, Rouse N, Patriche D, Radfar A. Public health burden of sleep disorders underreported problem. J Public Health 2016;25:243-248.
Koninklijke Philips N.V. Wake up call: global sleep satisfaction trends. Philips Global Survey \[Internet\] 2020 \[consultado 2022 junio 28\].
Other Identifiers
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PAC2422037
Identifier Type: -
Identifier Source: org_study_id
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