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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03692650
Other study ID # 201805059RINC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date December 14, 2018

Study information

Verified date September 2019
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Partial sleep deprivation (PSD), is a common problem among current university students in Taiwan. Students often get inadequate sleep time due to burden schoolwork during exam period. In recent years, Issue of sleep quality has gradually been emphasized. According to previous research, lacking in sleep easily results in sleepiness, fatigue, and poor problem-solving performance. Sleep deprivation may also affects cognitive performance, like reducing working memory performance. Furthermore, sleep deprivation will probably alter autonomic nervous function, such as sympathetic/parasympathetic activity change. Previous researches also suggested that sleep deprivation may associated with the risk of being obesity or suffering from diabetes. However, most researches focused on the effects of total sleep deprivation, especially those who usually have night shift work, such as medical staff. Few studies investigated the cognitive function and physiological function of university students after a period of time of partial sleep deprivation. As a results, the aim of the study is to investigate how partial sleep deprivation affects the cognitive performance and physiological function before and after the final exam period in healthy young university students between 20 and 30 years old in Taiwan, in order to promote the importance of healthy sleep and improve sleep quality among university students.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date December 14, 2018
Est. primary completion date December 14, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Taiwan University, College of Medicine, Department of Physical Therapy Taipei Zhongzheng

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (14)

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. Review. — View Citation

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. — View Citation

Knutson KL, Spiegel K, Penev P, Van Cauter E. The metabolic consequences of sleep deprivation. Sleep Med Rev. 2007 Jun;11(3):163-78. Epub 2007 Apr 17. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Pérez-Olmos I, Ibáñez-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. — View Citation

Purim KS, Guimarães 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. Portuguese, English. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2005 Feb 17. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary heart rate variability 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. Change from baseline heart rate variability at 4 weeks
Secondary Grasp strength(kilogram) 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
Secondary Single N-back test(correct rate, %) 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
Secondary Stroop effects(seconds) 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. Change from baseline performance(seconds) at 4 weeks
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