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Exploratory Study of Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics

2020년 1월 5일 업데이트: Carsten Skarke, MD, University of Pennsylvania

Exploratory Study in Healthy Volunteers to Define Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics

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.

연구 개요

상태

완전한

정황

상세 설명

Cell phones with internet access (so-called smartphones) represent a rich source for user activity data. Each time one places a call, sends a text message, or uses an app, a data trace is being produced which overall reflects the user's social activity and behavior. This data is called 'social sensing data'. Researchers connected this type of data to the health status of the person operating the cell phone. An example is that an outbreak of seasonal flu may lead to fewer calls and text messages among cell phone users. Thus, the social sensing data may show for example how severe an outbreak is and how fast it is spreading.

"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 rest and sleep occurs during nighttime. A disturbance of this pattern, for example by regular nightshift work, may lead to an increased disease risk, such as for the cardiovascular system, the heart and blood vessels. Natural factors within a body produce our 24-hour rhythm. This rhythm is affected by outside cues such as sunlight. Jet lag is a short-term form of a disturbed 24-hour rhythm. When a person travels fast through several time zones, by plane for example from the East to the West Coast of the US, s/he arrives with a time difference of 3 hours. Upon arrival, the body runs still at East Coast time, but is exposed to the environmental cues following the West Coast time, which may make the person feel groggy and disoriented at first. Within a couple of days the body time usually adjusts and the complaints discontinue.

The current study wishes to look for a relationship between patterns in the participant's cell phone use (Android only at this point) and several of the bodily functions. As bodily functions the investigators will measure blood pressure and breakdown products (metabolites) in urine, blood and saliva samples. The investigators will collect stool samples and use swabs to collect the microbes inhabiting the mouth as well as the rectum. The investigators will also measure messenger ribonucleic acid (mRNA), messenger products of the participant's heritable information, in the blood. A cell phone application called "Ginger.io" will collect the participants' cell phone usage information. This application will also ask the participant several questions during the installation, during participation as well as at the end. Furthermore, the investigators will ask the participant about the dietary intake and habits.

The aim is to learn how the 24-hour rhythm is connected to the social activity and behavior as well as blood pressure and metabolites as markers for the health status.

연구 유형

관찰

등록 (실제)

6

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

25년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Healthy volunteers

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 보병대
  • 시간 관점: 유망한

코호트 및 개입

그룹/코호트
Study group
Healthy volunteers

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Calls and Text Messages
기간: 3-4 months
Aggregate communication as behavioral features has been collected using the cell phone data streams.
3-4 months
Changes Over Time in Ambulatory Blood Pressure - Systolic Blood Pressure
기간: 48 hours
Ambulatory blood pressure monitoring
48 hours
Percentage of Total Metabolites
기간: 48 hours
Percentage of metabolites displaying different abundances in biosamples collected during the morning hours versus evening hours. Analysis was performed for all participants as a group.
48 hours
Mobility Radius
기간: 3-4 months
The approximate radius of an imaginary circle encompassing the various locations that a user has traveled across on a particular day (in miles)
3-4 months
Calls
기간: 3-4 months
Number of phone calls placed and received
3-4 months
Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure
기간: 48 hours
Ambulatory blood pressure monitoring
48 hours
Unanswered Calls
기간: 3-4 months
The number of calls unanswered.
3-4 months
Unique Contacts
기간: 3-4 months
The total number of unique individuals with whom a participant interacted through phone calls or sms messages indicating interaction diversity
3-4 months
Call Duration
기간: 3-4 months
The duration of calls (made + received)
3-4 months
Text Message Length
기간: 3-4 months
The total length of all sms messages (sent + received) in characters
3-4 months
Text Messages
기간: 3-4 months
The number of sms messages (sent + received)
3-4 months

2차 결과 측정

결과 측정
측정값 설명
기간
Self-reported Sleep Times [Survey]
기간: 3-4 months
Cell phone administered survey where participants indicated start and end of sleep times. From this the total hours of sleep per night was calculated.
3-4 months
Time Asleep
기간: 3-4 months
Hours asleep per each 24 hour period measured by actigraphy
3-4 months
Physical Activity
기간: 3-4 months
Difference in locomotion between wake and sleep times
3-4 months
Changes Over Time in Nutrient Intake - Energy
기간: 48 hours
Nutrient intake will be measured using food photography
48 hours
Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH
기간: 48 hours
48 hours
Genera Displaying Different Abundances Measured During Morning Versus Evening Hours in the Oral Microbiome
기간: 48 hours
Analysis was performed for all participants as a group.
48 hours
Proteins Displaying Different Abundances Measured in the Morning Versus Evening Hours
기간: 48 hours
Analysis was performed for all participants as a group.
48 hours
Changes Over Time in Kidney Function
기간: 48 hours
48 hours

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

협력자

수사관

  • 수석 연구원: Carsten Skarke, MD, University of Pennsylvania
  • 수석 연구원: Garret A FitzGerald, MD, University of Pennsylvania
  • 수석 연구원: Aalim Weljie, PhD, University of Pennsylvania

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 9월 1일

기본 완료 (실제)

2017년 12월 1일

연구 완료 (실제)

2017년 12월 1일

연구 등록 날짜

최초 제출

2014년 3월 25일

QC 기준을 충족하는 최초 제출

2014년 9월 25일

처음 게시됨 (추정)

2014년 9월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 1월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 1월 5일

마지막으로 확인됨

2020년 1월 1일

추가 정보

이 연구와 관련된 용어

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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