- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03692650
Influence of Cognition and Physiological Function by Partial Sleep Deprivation
Influence of Cognition and Physiological Function by Partial Sleep Deprivation of Taiwan University Students During Final Exam
Study Overview
Status
Conditions
Detailed Description
40 healthy young university students who meet the inclusion criteria will be enrolled to the study. The investigators will detailed explain the research process to participants, and make sure all participants provide written informed consent. The study will be conducted in clinical cardiopulmonary function lab in school and graduate institute of physical therapy, college of medicine, National Taiwan University. Baseline evaluation will be conducted after all the midterm exam complete, and make sure there is no sleep deprivation events two weeks before and after baseline evaluation. Outcome measurement will be on the day after all final exams complete.
Participants will need to wear ActiGraph GT3X monitor (ActiGraph LLC, Pensacola, FL, USA), which is a non-invasive sleep monitoring device in order to record precise sleep hours and sleep condition, five days before baseline and outcome evaluation. On the days of both baseline and outcome evaluation, the investigators will provide computer device for participants to perform cognitive performance test, which will take around 15 minutes to complete. Next, participants can take a rest for 10 minutes on the bed in supine position before heart rate variability measurement starts. The investigators will place electrode on participant's right forearm, then the non-invasive device will record heart rate variability data for about 5 to 10 minutes. At last, the investigators will evaluate participant's dominant hand grasp strength (kg) by Jamar hand dynamometer (Jackson, MI, USA) devices in standing position.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zhongzheng
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Taipei, Zhongzheng, Taiwan, 100
- National Taiwan University, College of Medicine, Department of Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- healthy young university students
Exclusion Criteria:
- People who cannot cooperate with the research
- Any medication that may affects the autonomic nervous system(such as beta blockers)
- Pregnancy
- People who have serious musculoskeletal/neurological/cardiopulmonary disorder or other systemic diseases that cannot complete the whole research tasks
- People who have already been diagnosed with any kinds of sleep disorders
- Without sleeping for more than 24 hours
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
heart rate variability
Time Frame: Change from baseline heart rate variability at 4 weeks
|
The investigator will use heart rate variation analyzer (SS1C,.
Enjoy Research Inc., Taipei, Taiwan) to measure heart rate variability.
Participant will lie on the bed in supine position, resting for 10 minutes before measurement.
Baseline evaluation will be conducted on two weeks after all midterm exams completed and at least two months before the final exams starts.
Outcome measurement will be on the first day after all final exams subjects complete.
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Change from baseline heart rate variability at 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grasp strength(kilogram)
Time Frame: Change from baseline grasp strength at 4 weeks
|
The investigator will adopt Jamar hand dynamometer (Jackson, MI, USA) devices to evaluate dominant hand grasp strength(kg) of the participants.
Each participant will perform 3 attempts maximal isometric muscle contractions in standing position and forearm neutral position, and the best performance will be recorded as an outcome.
Baseline evaluation will be conducted on two weeks after all midterm exams completed and at least two months before the final exams starts.
Outcome measurement will be on the first day after all final exams subjects complete.
|
Change from baseline grasp strength at 4 weeks
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Single N-back test(correct rate, %)
Time Frame: Change from baseline correct rate at 4 weeks
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Single n-back test will be used to evaluate working memory function and attention.
The investigators will provide computer devices for all participants.
Participants will perform 3 same tasks, each task spend 1 minutes.
The average percentage of correct rate will be recorded as the outcome.
Baseline evaluation will be conducted on two weeks after all midterm exams completed and at least two months before the final exams starts.
Outcome measurement will be on the first day after all final exams subjects complete.
|
Change from baseline correct rate at 4 weeks
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Stroop effects(seconds)
Time Frame: Change from baseline performance(seconds) at 4 weeks
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Stroop effects is widely used to evaluate attention, executive function, inhibition process, and automatic responses.
The investigators will provide standard stroop charts(Traditional Chinese version) for all participants, which include 4 small parts in this charts.
The investigators will record the time(seconds) of each parts that participant needs to complete as the outcome.
Baseline evaluation will be conducted on two weeks after all midterm exams completed and at least two months before the final exams starts.
Outcome measurement will be on the first day after all final exams subjects complete.
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Change from baseline performance(seconds) at 4 weeks
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Collaborators and Investigators
Investigators
- Study Chair: Meng Yueh Chien, PhD, National Taiwan University, College of Medicine, Department of Physical Therapy
Publications and helpful links
General Publications
- Wang ML, Lin PL, Huang CH, Huang HH. Decreased Parasympathetic Activity of Heart Rate Variability During Anticipation of Night Duty in Anesthesiology Residents. Anesth Analg. 2018 Mar;126(3):1013-1018. doi: 10.1213/ANE.0000000000002439.
- Hirshkowitz M, Whiton K, Albert SM, Alessi C, Bruni O, DonCarlos L, Hazen N, Herman J, Katz ES, Kheirandish-Gozal L, Neubauer DN, O'Donnell AE, Ohayon M, Peever J, Rawding R, Sachdeva RC, Setters B, Vitiello MV, Ware JC, Adams Hillard PJ. National Sleep Foundation's sleep time duration recommendations: methodology and results summary. Sleep Health. 2015 Mar;1(1):40-43. doi: 10.1016/j.sleh.2014.12.010. Epub 2015 Jan 8.
- Knutson KL, Spiegel K, Penev P, Van Cauter E. The metabolic consequences of sleep deprivation. Sleep Med Rev. 2007 Jun;11(3):163-78. doi: 10.1016/j.smrv.2007.01.002. Epub 2007 Apr 17.
- Patrick Y, Lee A, Raha O, Pillai K, Gupta S, Sethi S, Mukeshimana F, Gerard L, Moghal MU, Saleh SN, Smith SF, Morrell MJ, Moss J. Effects of sleep deprivation on cognitive and physical performance in university students. Sleep Biol Rhythms. 2017;15(3):217-225. doi: 10.1007/s41105-017-0099-5. Epub 2017 Apr 13.
- Perez-Olmos I, Ibanez-Pinilla M. Night shifts, sleep deprivation, and attention performance in medical students. Int J Med Educ. 2014 Mar 29;5:56-62. doi: 10.5116/ijme.531a.f2c9.
- Saadat H, Bissonnette B, Tumin D, Raman V, Rice J, Barry N, Tobias J. Effects of partial sleep deprivation on reaction time in anesthesiologists. Paediatr Anaesth. 2017 Apr;27(4):358-362. doi: 10.1111/pan.13035. Epub 2016 Nov 30.
- Hershner SD, Chervin RD. Causes and consequences of sleepiness among college students. Nat Sci Sleep. 2014 Jun 23;6:73-84. doi: 10.2147/NSS.S62907. eCollection 2014.
- Purim KS, Guimaraes AT, Titski AC, Leite N. Sleep deprivation and drowsiness of medical residents and medical students. Rev Col Bras Cir. 2016 Dec;43(6):438-444. doi: 10.1590/0100-69912016006005. English, Portuguese.
- Tobaldini E, Costantino G, Solbiati M, Cogliati C, Kara T, Nobili L, Montano N. Sleep, sleep deprivation, autonomic nervous system and cardiovascular diseases. Neurosci Biobehav Rev. 2017 Mar;74(Pt B):321-329. doi: 10.1016/j.neubiorev.2016.07.004. Epub 2016 Jul 7.
- Pasula EY, Brown GG, McKenna BS, Mellor A, Turner T, Anderson C, Drummond SPA. Effects of sleep deprivation on component processes of working memory in younger and older adults. Sleep. 2018 Mar 1;41(3). doi: 10.1093/sleep/zsx213.
- Nano MM, Fonseca P, Vullings R, Aarts RM. Measures of cardiovascular autonomic activity in insomnia disorder: A systematic review. PLoS One. 2017 Oct 23;12(10):e0186716. doi: 10.1371/journal.pone.0186716. eCollection 2017.
- Zhong X, Hilton HJ, Gates GJ, Jelic S, Stern Y, Bartels MN, Demeersman RE, Basner RC. Increased sympathetic and decreased parasympathetic cardiovascular modulation in normal humans with acute sleep deprivation. J Appl Physiol (1985). 2005 Jun;98(6):2024-32. doi: 10.1152/japplphysiol.00620.2004. Epub 2005 Feb 17.
- Lo JC, Ong JL, Leong RL, Gooley JJ, Chee MW. Cognitive Performance, Sleepiness, and Mood in Partially Sleep Deprived Adolescents: The Need for Sleep Study. Sleep. 2016 Mar 1;39(3):687-98. doi: 10.5665/sleep.5552.
- Kuriyama K, Mishima K, Suzuki H, Aritake S, Uchiyama M. Sleep accelerates the improvement in working memory performance. J Neurosci. 2008 Oct 1;28(40):10145-50. doi: 10.1523/JNEUROSCI.2039-08.2008.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201805059RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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