N/A
N=6
Exploratory Study of Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02249793 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Calls and Text Messages — 18.7; 0.9 Calls and text messages
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Calls and Text Messages |
18.7; 0.9 | — |
| PRIMARY Changes Over Time in Ambulatory Blood Pressure - Systolic Blood Pressure |
20.7; 126.1; 106.8 | — |
| PRIMARY Percentage of Total Metabolites |
5.4; 5.6 | — |
| PRIMARY Mobility Radius |
6.8 | — |
| PRIMARY Calls |
2.7; 0.1 | — |
| PRIMARY Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure |
20.7; 78.5; 58.8 | — |
| PRIMARY Unanswered Calls |
0.6; 0.03 | — |
| PRIMARY Unique Contacts |
7.2; 0.5 | — |
| PRIMARY Call Duration |
820.4; 22.0 | — |
| PRIMARY Text Message Length |
868.0; 47.0 | — |
| PRIMARY Text Messages |
16.0; 0.8 | — |
| SECONDARY Self-reported Sleep Times [Survey] |
7.6 | — |
| SECONDARY Time Asleep |
7.931449224 | — |
| SECONDARY Physical Activity |
1904.0; 307.2 | — |
| SECONDARY Changes Over Time in Nutrient Intake - Energy |
1967; 1609 | — |
| SECONDARY Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH |
23.3; 17.9 | — |
| SECONDARY Genera Displaying Different Abundances Measured During Morning Versus Evening Hours in the Oral Microbiome |
3 | — |
| SECONDARY Proteins Displaying Different Abundances Measured in the Morning Versus Evening Hours |
2 | — |
| SECONDARY Changes Over Time in Kidney Function |
12.925 | — |
Summary
As citizens of the information age, humans leave digital traces of behavior in their communication and movement patterns through our cell phone. The Global Positioning System (GPS) technology tracks the way persons commute to school or work or when visiting family and friends. Circadian rhythmicity describes the concept that many of the bodily functions follow a roughly 24-hour rhythm. Usually, the ability to do concentrated and focused work is best during daytime while humans rest and sleep during nighttime. The current study wishes to look for a relationship between patterns in participants' cell phone use (Android only at this point) and several of their bodily functions.
Eligibility Criteria
Inclusion Criteria
- Volunteers must be in good health as based on medical history, physical examination, vital signs, and laboratory tests as deemed by PI;
- Volunteers are capable of giving informed consent;
- 25-35 years of age;
- Own a cell phone with internet access (smartphone with Android operating system only at this point) which installs the social sensing application ginger.io;
- Non-smoking;
- Male subjects only if feasible during recruitment; and
- In case female volunteers are invited to enroll: non-pregnant, female subjects must consent to a urine pregnancy test.
Exclusion Criteria
- Recent travel across time zones (within the past month);
- Planned travel across time zones during the planned study activities;
- Volunteers with irregular work hours, e.g. night shifts.
- Use of illicit drugs;
- Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening.
- Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject.
Data sourced from ClinicalTrials.gov (NCT02249793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.