Clinical Efficacy of a Supplement on Sleep Quality

Study Overview
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Brief Summary
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This is a prospective randomized clinical study of 30 patients to evaluate a novel sleep supplement. This study will be evaluating the effectiveness of the supplement over a 2 month program. The study will assess the effects that the supplement has on a patient's sleep metrics and epigenetic age biomarkers.

Official Title
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Clinical Efficacy of a Novel Delivery Supplement on Sleep Quality

Conditions
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Sleep

Intervention / Treatment
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* Dietary Supplement: Circadian Wellness sleep SL strip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women of any ethnicity. Age Range - 16 - 65 Patient must be able to comply with treatment plan and laboratory tests Exclusion Criteria: Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision No immune system issues or immunodeficiency disease No history of viral illness which could be reactivated by immune downregulation Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke) Diagnosis of a transient ischemic attack in the 6 months prior to screening Patients infected with hepatitis, C or HIV Patients with Body Mass Index (BMI) > 40 kg/m2 Presence of active infection Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study Unable or unwilling to provide required blood sample for testing As for the male-participants they are recommended to avoid fertilization for the first 6 months after the clinical trial. If the patient has previously used any products in a month prior to the start of the trial. Known sleep disorder ie. obstructive sleep apnea Presence of schizophrenia, bipolar disorder Concurrent use of cannabis

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients will be in the control group for 1 month and in the intervention group for one month
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep supplement<br>Circadian Wellness sleep SL strip nightly for 30 days. | Dietary Supplement: Circadian Wellness sleep SL strip<br>* Participants in the intervention group will be asked to begin Circadian Wellness sleep SL strip nightly for 30 days. Participants will continue the supplementation for the 30 days.<br>|
| Placebo Comparator: Control Group<br>Participants in the control group will have no intervention and no change in their usual daily routine or supplements. They will be asked to not take any sleep aid supplement during the study period. | Dietary Supplement: Circadian Wellness sleep SL strip<br>* Participants in the intervention group will be asked to begin Circadian Wellness sleep SL strip nightly for 30 days. Participants will continue the supplementation for the 30 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epigenetic Age |  | Change from baseline to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep duration |  | change from baseline to 2 months |