NCT06333301

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
96mo left

Started Apr 2024

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Apr 2024Apr 2034

First Submitted

Initial submission to the registry

March 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2034

Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

10 years

First QC Date

March 20, 2024

Last Update Submit

March 26, 2024

Conditions

Biological Aging

Keywords

SleepChronotype

Outcome Measures

Primary Outcomes (1)

  • 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

    At baseline

Secondary Outcomes (3)

  • Effect of Chronotype Alignment and Depression Risk in Relation to Rate of Aging

    At baseline

  • Identification of DNA methylation markers associated with chronotype

    At baseline

  • Identification of DNA methylation markers associated with depression

    At baseline

Study Arms (1)

TIME-ZZZ

Group will complete several surveys

Other: Surveys

Interventions

SurveysOTHER

Group will complete several surveys

TIME-ZZZ

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults

You may qualify if:

  • 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

You may not qualify if:

  • Consent to participate not given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Dayle Sampson, PhD

    Elysium Health

    PRINCIPAL INVESTIGATOR

  • Russell Foster, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan W Dellinger, PhD

CONTACT

8882206436care@elysiumhealth.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2024

First Posted

March 27, 2024

Study Start

April 1, 2024

Primary Completion (Estimated)

April 1, 2034

Study Completion (Estimated)

April 1, 2034

Last Updated

March 27, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share