SleepNCT04988542
Clinical Efficacy of a Supplement on Sleep Quality
A study testing Circadian Wellness sleep SL strip in people with Sleep, run by TruDiagnostic.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Circadian Wellness sleep SL strip
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2021to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Men and women of any ethnicity.
- Age Range - 16 - 65
- Patient must be able to comply with treatment plan and laboratory tests
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
Annie Prestrud contact
About this study
Official title: Clinical Efficacy of a Novel Delivery Supplement on Sleep Quality
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.
- Conditions
- Sleep
- Being tested
- Circadian Wellness sleep SL strip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian Wellness sleep SL stripDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep supplement | Experimental | Circadian Wellness sleep SL strip nightly for 30 days. Receives: Dietary Supplement: Circadian Wellness sleep SL strip |
| Control Group | Placebo comparator | 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. Receives: Dietary Supplement: Circadian Wellness sleep SL strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetic Age
Measured: Change from baseline to 2 months
Secondary outcomes (1)
Sleep duration
Measured: change from baseline to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start30 Aug 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will be in the control group for 1 month and in the intervention group for one month
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TruDiagnostic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Circadian Wellness Corp
- Responsible party
- Sponsor
- Investigators
- Sanjeev Goel, Principal investigator, Peak Human Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988542
- Sponsor's protocol ID
- TD-SQ-001
- Status last verified
- Aug 2021
- First submitted
- 26 Jul 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cui XY, Cui SY, Zhang J, Wang ZJ, Yu B, Sheng ZF, Zhang XQ, Zhang YH. Extract of Ganoderma lucidum prolongs sleep time in rats. J Ethnopharmacol. 2012 Feb 15;139(3):796-800. doi: 10.1016/j.jep.2011.12.020. Epub 2011 Dec 21.
PubMed 22207209
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of a Novel Delivery Supplement on Sleep Quality
- ClinicalTrials.gov ID
- NCT04988542
- Acronym / sponsor ID
- TD-SQ-001
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- TruDiagnosticIndustry (pharma, biotech, devices)
- Collaborators
- Circadian Wellness Corp
- Study start
- 30 Aug 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be in the control group for 1 month and in the intervention group for one month
| Arm | Type | Receives |
|---|---|---|
| Sleep supplement | Experimental | Dietary Supplement: Circadian Wellness sleep SL stripCircadian Wellness sleep SL strip nightly for 30 days. |
| Control Group | Placebo comparator | Dietary Supplement: Circadian Wellness sleep SL stripParticipants 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. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women of any ethnicity.
- Age Range - 16 - 65
- Patient must be able to comply with treatment plan and laboratory tests
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circadian Wellness sleep SL stripParticipants 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. | Dietary supplement | Control Group, Sleep supplement |
Primary outcome
Epigenetic Age
Time frame: Change from baseline to 2 months
1 secondary outcome
Sleep duration
Time frame: change from baseline to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Background: PubMed 22207209Cui XY, Cui SY, Zhang J, Wang ZJ, Yu B, Sheng ZF, Zhang XQ, Zhang YH. Extract of Ganoderma lucidum prolongs sleep time in rats. J Ethnopharmacol. 2012 Feb 15;139(3):796-800. doi: 10.1016/j.jep.2011.12.020. Epub 2011 Dec 21.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annie Prestrud contact
Sanjeev Goel principal investigator
Peak Human Labs
Questions about this trial
What is this clinical trial studying?
A study testing Circadian Wellness sleep SL strip in people with Sleep, run by TruDiagnostic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanjeev Goel, MD (647-966-4385, DRGOEL@PEAKHUMAN.CA), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic Age (time frame: Change from baseline to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04988542, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.