Translational Initiative to Map Epigenetics in Sleep | NCT06333301

Studies
Translational Initiative to Map Epigenetics in Sleep

NCT06333301

Sponsor

Elysium Health

Status

Not yet recruiting

Last Update Posted

Mar 27, 2024Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Biological Aging

Interventions

Surveys

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2024Estimated

Primary Completion Date

Apr 2034Estimated

Completion Date

Apr 2034Estimated

First Submitted Date

Mar 20, 2024

First Submission Date that Met QC Criteria

Mar 26, 2024

First Posted Date

Mar 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2024

Last Update Posted Date

Mar 27, 2024Actual

Name	Class
University of Oxford	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TIME-ZZZ		Group will complete several surveys	Other: Surveys

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surveys	Other	Group will complete several surveys	TIME-ZZZ

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	At baseline
Identification of DNA methylation markers associated with chronotype

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ryan W Dellinger, PhD	Contact	8882206436		care@elysiumhealth.com

Overall Officials

Name	Affiliation	Role
Dayle Sampson, PhD	Elysium Health	Principal Investigator
Russell Foster, PhD	University of Oxford	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided