Translational Initiative to Map Epigenetics in Sleep (TIME-ZZZ)

March 26, 2024 updated by: Elysium Health
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy adults

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Consent to participate not given

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TIME-ZZZ
Group will complete several surveys
Other: Surveys
Group will complete several surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Chronotype Alignment and Depression Risk in Relation to Rate of Aging
Time Frame: At baseline
Determine the effect of chronotype alignment and depression risk (from TIME-ZZZ surveys) on biological rate of aging
At baseline
Identification of DNA methylation markers associated with chronotype
Time Frame: At baseline
Identify specific DNA methylation markers associated with chronotype (from TIME-ZZZ surveys) thereby providing potential insights into the epigenetic regulation of sleep-wake patterns
At baseline
Identification of DNA methylation markers associated with depression
Time Frame: At baseline
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.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elysium Health

Collaborators

University of Oxford

Investigators

  • Principal Investigator: Dayle Sampson, PhD, Elysium Health
  • Principal Investigator: Russell Foster, PhD, University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2034

Study Completion (Estimated)

April 1, 2034

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TIME-ZZZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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