Clinical Efficacy of a Supplement on Sleep Quality

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2022-04-30

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.

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Detailed Description

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Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients will be in the control group for 1 month and in the intervention group for one month

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sleep supplement

Circadian Wellness sleep SL strip nightly for 30 days.

Group Type EXPERIMENTAL

Circadian Wellness sleep SL strip

Intervention Type DIETARY_SUPPLEMENT

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.

Control Group

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.

Group Type PLACEBO_COMPARATOR

Circadian Wellness sleep SL strip

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Circadian Wellness sleep SL strip

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.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes