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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04086589
Other study ID # 832866
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date August 19, 2019
Est. completion date December 17, 2024

Study information

Verified date December 2023
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Suspended
Enrollment 40
Est. completion date December 17, 2024
Est. primary completion date July 17, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observational study without intervention
Observational study without intervention

Locations

Country Name City State
United States University of Pennsylvania School of Medicine Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Chronotype Assessed per survey; chronotypes per Munich Chronotype questionnaire are extreme early type, moderate early type, slight early type, normal type, slight late type, moderate late type, extreme late type 4 weeks
Secondary Acrophase Clock hour of peak physical activity averaged from 7 or more days of actigraphy 7 days
Secondary Physical activity Vector magnitude of physical activity averaged from 7 or more days of actigraphy 7 days
Secondary Sleep quantity Hours of sleep averaged from 7 or more days of actigraphy 7 or more days
Secondary Sleep quality: actigraphy Sleep fragmentation averaged from 7 or more days of actigraphy 7 days
Secondary Ambient light exposure Ambient light exposure averaged from 7 or more days of actigraphy 7 days
Secondary Heart rate variability Heart rate variability (RR intervals) averaged from 24 hours of BioPatch 24 hours
Secondary Saliva cortisol Difference in concentrations of cortisol measured in saliva between morning versus evening 24 hours
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