Novel Formulation for Sleep Among People With Poor Sleep Quality

Study Overview
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Brief Summary
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Sleep disorders are highly prevalent all around the world and have a strong negative impact on quality of life (QoL). In Colombia, up to 60% of adults report any sleep disturbance and more than 45% have required medical assistance for this. There is abundant anecdotal and scientific evidence supporting the efficacy and safety of several plant extracts on sleep quality. In this context, the development of safe and effective natural products may have a positive impact on sleep and general QoL.

Detailed Description
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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.

Official Title
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Effect of a Novel Formulation on Sleep Parameters Among People With Poor Sleep Quality: A Randomized Controlled Trial

Conditions
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Sleep, Sleep Disorder, Insomnia, Quality of Life, Poor Quality Sleep

Intervention / Treatment
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* Dietary Supplement: Supplement
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active intervention<br>A formulation made of natural components. Each sachet contains saffron, tea extract, lemon balm and valerian. | Dietary Supplement: Supplement<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo sachet will contain inert excipient. | Other: Placebo<br>* Placebo sachet Dose: The participant will take one sachet everyday, one hour before going to bed, for six weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency | 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 | 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 | Change in QoL measured by the 36-Item Short Form Survey (SF-36) | Baseline (week 0) - Final (week 6) | 
| Morning salivary cortisol | Change in salivary cortisol (as a measurement of response to stress) | Baseline (week 0) - Final (week 6) | 
| Blood creatinine | Change in blood creatinine | Baseline (week 0) - Final (week 6) | 
| Blood alanine amino transferase | Change in blood alanine amino transferase | Baseline (week 0) - Final (week 6) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Supplement, Nutraceutical, Health, Quality of life, Actigraphy