Biological AgingTIME-ZZZNCT06333301
Translational Initiative to Map Epigenetics in Sleep
An observational study of Biological Aging, run by Elysium Health.
Trial summary
The primary aim of TIME-ZZZ is to explore the relationship between chronotype, incidence of depression and biological age, and whether individuals working "out-of-phase" with their chronotype are more likely to exhibit signs of depression and accelerated biological aging. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Biological Aging
- What is being tested?
- Surveys
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Apr 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults
Who may be able to join
- Has taken an INDEX test within the last 3 months
- Has registered at least 1 INDEX kit via the Elysium Health website
- Able and willing to provide digital consent to the RSCF, and the TIME-ZZZ Research Subject Consent Form
Who cannot join
- Consent to participate not given
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The primary aim of TIME-ZZZ is to explore the relationship between chronotype, incidence of depression and biological age, and whether individuals working "out-of-phase" with their chronotype are more likely to exhibit signs of depression and accelerated biological aging.
Read the detailed description
Understanding the relationship between chronotype, depression, and biological age is important in the field of sleep research and mental health. Sleep patterns and their alignment with an individual's internal body clock, or chronotype, have been increasingly recognized as influential factors in various aspects of well-being, including mental health and overall physiological aging. By conducting a study that investigates the potential correlation between chronotype, incidence of depression, and biological age, along with the impact of working "out-of-phase" with one's chronotype, the investigators can shed light on crucial aspects of sleep, mental health, and their interplay with biological aging.
- Conditions
- Biological Aging
- Being tested
- Surveys
- Keywords
- Sleep, Chronotype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
Group will complete several surveys
| Study group | Role | What they receive |
|---|---|---|
| TIME-ZZZ | Group will complete several surveys Receives: Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of being "out of phase" with chronotype on biological age
Determine whether individuals working "out-of-phase" with their chronotype (from TIME-ZZZ survey responses) exhibit higher rates of biological aging compared to those working within their chronotype
Measured: At baseline
Secondary outcomes (3)
Effect of Chronotype Alignment and Depression Risk in Relation to Rate of Aging
Determine the effect of chronotype alignment and depression risk (from TIME-ZZZ surveys) on biological rate of aging
Measured: At baseline
Identification of DNA methylation markers associated with chronotype
Identify specific DNA methylation markers associated with chronotype (from TIME-ZZZ surveys) thereby providing potential insights into the epigenetic regulation of sleep-wake patterns
Measured: At baseline
Identification of DNA methylation markers associated with depression
Identify specific DNA methylation markers associated with depression (from TIME-ZZZ surveys) potentially shedding light on the underlying epigenetic mechanisms involved in the development and progression of depressive disorders.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2034 (estimated)
- Study completionApr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological AgingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elysium Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Dayle Sampson, PhD, Principal investigator, Elysium HealthRussell Foster, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333301
- Sponsor's protocol ID
- TIME-ZZZ
- Acronym
- TIME-ZZZ
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Initiative to Map Epigenetics in Sleep
- ClinicalTrials.gov ID
- NCT06333301
- Acronym / sponsor ID
- TIME-ZZZ / TIME-ZZZ
- Conditions
- Biological Aging
- Keywords
- Sleep, Chronotype
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Elysium HealthIndustry (pharma, biotech, devices)
- Collaborators
- University of Oxford
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2034 (estimated)
- Study completion
- Apr 2034 (estimated)
- First posted
- 27 Mar 2024 (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.
The primary aim of TIME-ZZZ is to explore the relationship between chronotype, incidence of depression and biological age, and whether individuals working "out-of-phase" with their chronotype are more likely to exhibit signs of depression and accelerated biological aging.
Detailed description
Understanding the relationship between chronotype, depression, and biological age is important in the field of sleep research and mental health. Sleep patterns and their alignment with an individual's internal body clock, or chronotype, have been increasingly recognized as influential factors in various aspects of well-being, including mental health and overall physiological aging. By conducting a study that investigates the potential correlation between chronotype, incidence of depression, and biological age, along with the impact of working "out-of-phase" with one's chronotype, the investigators can shed light on crucial aspects of sleep, mental health, and their interplay with biological aging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIME-ZZZ | – | Other: SurveysGroup will complete several surveys |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults
Key inclusion criteria (3 listed)
- Has taken an INDEX test within the last 3 months
- Has registered at least 1 INDEX kit via the Elysium Health website
- Able and willing to provide digital consent to the RSCF, and the TIME-ZZZ Research Subject Consent Form
Key exclusion criteria (1 listed)
- Consent to participate not given
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 |
|---|---|---|
| SurveysGroup will complete several surveys | Other | TIME-ZZZ |
Primary outcome
Effect of being "out of phase" with chronotype on biological age
Time frame: At baseline
Determine whether individuals working "out-of-phase" with their chronotype (from TIME-ZZZ survey responses) exhibit higher rates of biological aging compared to those working within their chronotype
3 secondary outcomes
Effect of Chronotype Alignment and Depression Risk in Relation to Rate of Aging
Time frame: At baseline
Identification of DNA methylation markers associated with chronotype
Time frame: At baseline
Identification of DNA methylation markers associated with depression
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Dayle Sampson, PhD principal investigator
Elysium Health
Russell Foster, PhD principal investigator
University of Oxford
Questions about this trial
What is this clinical trial studying?
An observational study of Biological Aging, run by Elysium Health.
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 1 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: opening soon, as of the sponsor's last update on 27 Mar 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan W Dellinger, PhD (8882206436, care@elysiumhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of being "out of phase" with chronotype on biological age (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2024.