- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05609890
Novel Formulation for Sleep Among People With Poor Sleep Quality
Effect of a Novel Formulation on Sleep Parameters Among People With Poor Sleep Quality: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It is estimated that up to 90% of people will have a sleep concern over their adult life. According to a worldwide survey, one out of two people report unsatisfactory sleep. In Colombia, a Latin American country, more than 60% of adults report sleep concerns. For a long time, positive effects on sleep of plant extracts have been described, and more recently their mechanisms of action and safety have been largely elucidated. This study aims to assess the efficacy and safety of a supplement formulation based on natural products (Saffron, Tea extract, Lemon Balm and Valerian) on objective and subjective sleep parameters.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carlos O Mendivil, MD, PhD
- Phone Number: 3780 +57 3394949
- Email: cmendivi@uniandes.edu.co
Study Locations
-
-
Bogota
-
Bogotá, Bogota, Colombia, 110111
- Universidad de los Andes, School of Medicine
-
Contact:
- Carlos O Mendivil, MD, PhD
- Phone Number: 3780 +57 3394949
- Email: cmendivi@uniandes.edu.co
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age >=18, male or female.
- PSQI >=5
- Provision of informed consent
- Adherence >= 85%
Exclusion Criteria:
- Medical history of a specific sleep disorder according to the DSM-5
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active intervention
A formulation made of natural components.
Each sachet contains saffron, tea extract, lemon balm and valerian.
|
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 Comparator: Placebo
Placebo sachet will contain inert excipient.
|
Placebo sachet Dose: The participant will take one sachet everyday, one hour before going to bed, for six weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep efficiency
Time Frame: Baseline (week 0) - Final (week 6)
|
The change (Week 6 - baseline) in Sleep Efficiency (the ratio of total sleep time to time in bed)
|
Baseline (week 0) - Final (week 6)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburg Sleep Quality Index (PSQI) (0-21) higher scores means worse sleep quality
Time Frame: Baseline (week 0) - Final (week 6)
|
Change from baseline in the PSQI
|
Baseline (week 0) - Final (week 6)
|
Short Form-36 Quality of Life score (SF-36) (0-100), higher score means better quality of life
Time Frame: Baseline (week 0) - Final (week 6)
|
Change in QoL measured by the 36-Item Short Form Survey (SF-36)
|
Baseline (week 0) - Final (week 6)
|
Morning salivary cortisol
Time Frame: Baseline (week 0) - Final (week 6)
|
Change in salivary cortisol (as a measurement of response to stress)
|
Baseline (week 0) - Final (week 6)
|
Blood creatinine
Time Frame: Baseline (week 0) - Final (week 6)
|
Change in blood creatinine
|
Baseline (week 0) - Final (week 6)
|
Blood alanine amino transferase
Time Frame: Baseline (week 0) - Final (week 6)
|
Change in blood alanine amino transferase
|
Baseline (week 0) - Final (week 6)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
Helpful Links
- 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].
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAC2422037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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