NCT04086589

Brief Summary

The goal is to address the mechanisms that account for alteration of circadian rhythms with age. As the blood of aged individuals can produce this alteration, the investigators propose to use such blood samples to "age" circadian rhythms in cultured cells. The investigators will verify aged blood-dependent alteration of rhythms and then conduct molecular screens to reverse this decline. If the investigators identify specific genes that can restore molecular circadian rhythm in vitro, the investigators will explore these in animal models (Drosophila, mouse).

Trial Health

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Trial Health Score

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

Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
30mo left

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

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 Progress73%
Aug 2019Nov 2028

First Submitted

Initial submission to the registry

August 19, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 19, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

8.4 years

First QC Date

August 19, 2019

Last Update Submit

January 21, 2026

Conditions

Healthy YoungHealthy Elderly

Keywords

healthy, young, elderly

Outcome Measures

Primary Outcomes (2)

  • Delta of period length measured in hh:mm between in vitro cycling fibroblasts incubated with serum collected from cases (elderly adults) versus controls (young adults)

    To determine if serum collected from young versus old healthy study participants have a differential effect on the expression of circadian rhythms in an in vitro culture of a fibroblast cell line

    Time point 14:00 Hours

  • Delta of phase measured in HH:mm between in vitro cycling fibroblasts incubated with serum collected from cases (elderly adults) versus controls (young adults)

    The primary endpoint will be the difference in phase angle in vitro between cycling fibroblasts and incubated with serum collected from cases (old adults) versus controls (young adults)

    Time point 14:00 Hours

Secondary Outcomes (8)

  • Chronotype

    4 weeks

  • Acrophase

    7 days

  • Physical activity

    7 days

  • Sleep quantity

    7 or more days

  • Sleep quality: actigraphy

    7 days

  • +3 more secondary outcomes

Study Arms (2)

Young

Observational study without intervention

Other: Observational study without intervention

Elderly

Observational study without intervention

Other: Observational study without intervention

Interventions

Observational study without interventionOTHER

Observational study without intervention

ElderlyYoung

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Apparent healthy volunteers

You may qualify if:

  • General good health with the following conditions permissible
  • cardiovascular risk prevention, intake of low dose aspirin,
  • hypertension, intake of beta-blockers, ACE inhibitors, diuretics, calcium channel blockers
  • hypercholesterinemia, intake of statins
  • Cases: 70-85 years of age
  • Controls: 20-35 years of age
  • Patients must be able to read and understand English
  • Participants must sign the informed consent form
  • Participants must have a wrist-actigraphy-based average TST (total sleep time) ≥ 6 hours per night (measured over 7 consecutive days) occurring between 22:00 - 08:00

You may not qualify if:

  • Known history of severe psychiatric or cognitive conditions, for example mania, schizophrenia, or mental retardation
  • Shift work, defined as recurring work between 22:00-05:00
  • History of clinically significant obstructive sleep apnea
  • Transmeridian travel across ≥2 time zones in the two weeks prior to the blood draws and one week after,
  • \> 2 drinks of alcohol per day
  • Use of illicit drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

ObservationMethods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Carsten Skarke, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2019

First Posted

September 11, 2019

Study Start

August 19, 2019

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

US(1)