Sleep DeprivationNCT03692650
Influence of Cognition and Physiological Function by Partial Sleep Deprivation
An observational study of Sleep Deprivation, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2018to 14 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The investigators will recruit 40 healthy young university students between 20 to 30 years old as research participants
Who may be able to join
- healthy young university students
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University, College of Medicine, Department of Physical Therapy
Taipei, Zhongzheng, 100
About this study
Official title: Influence of Cognition and Physiological Function by Partial Sleep Deprivation of Taiwan University Students During Final Exam
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.
Read the 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.
- Conditions
- Sleep Deprivation
- Medical subject headings
- Sleep Deprivation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline heart rate variability at 4 weeks
Secondary outcomes (3)
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.
Measured: Change from baseline grasp strength at 4 weeks
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.
Measured: Change from baseline correct rate at 4 weeks
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.
Measured: Change from baseline performance(seconds) at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Sep 2018
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng Yueh Chien, PhD, Study chair, National Taiwan University, College of Medicine, Department of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692650
- Sponsor's protocol ID
- 201805059RINC
- Status last verified
- Sep 2019
- First submitted
- 20 Sep 2018
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28680341Hirshkowitz 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.
PubMed 29073412Perez-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.
PubMed 25341213Saadat 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.
PubMed 27900800Hershner 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.
PubMed 25018659Purim 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.
PubMed 28273216Tobaldini 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.
PubMed 27397854Knutson 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.
PubMed 17442599Pasula 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.
PubMed 29361107Wang 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.
PubMed 29200073Nano 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.
PubMed 29059210Zhong 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.
PubMed 15718408Lo 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.
PubMed 26612392Kuriyama 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.
PubMed 18829972
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Cognition and Physiological Function by Partial Sleep Deprivation of Taiwan University Students During Final Exam
- ClinicalTrials.gov ID
- NCT03692650
- Acronym / sponsor ID
- 201805059RINC
- Conditions
- Sleep Deprivation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The investigators will recruit 40 healthy young university students between 20 to 30 years old as research participants
Key inclusion criteria (1 listed)
- healthy young university students
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Grasp strength(kilogram)
Time frame: Change from baseline grasp strength at 4 weeks
Single N-back test(correct rate, %)
Time frame: Change from baseline correct rate at 4 weeks
Stroop effects(seconds)
Time frame: Change from baseline performance(seconds) at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Background: PubMed 28680341Patrick 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.
- Background: PubMed 29073412Hirshkowitz 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.
- Background: PubMed 25341213Perez-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.
- Background: PubMed 27900800Saadat 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.
- Background: PubMed 25018659Hershner 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.
- Background: PubMed 28273216Purim 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.
- Background: PubMed 27397854Tobaldini 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.
- Background: PubMed 17442599Knutson 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.
- Background: PubMed 29361107Pasula 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.
- Background: PubMed 29200073Wang 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.
- Background: PubMed 29059210Nano 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.
- Background: PubMed 15718408Zhong 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.
- Title: Lifestyle and Environmental Factors Associated with Sleep Quality of PreserviceLink provided by the sponsor.
- Title: The Effects of Three Physical Trainings on Heart Rate Variability of the College Students after Sleep DeprivationLink provided by the sponsor.
- Title: Sleep Deprivation and Fatigue in CliniciansLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng Yueh Chien, PhD study chair
National Taiwan University, College of Medicine, Department of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Deprivation, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate variability (time frame: Change from baseline heart rate variability at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03692650, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.