Completed
NCT Number: NCT02690311
A Study on the Changes of the Biological Rhythm by Display Image Modulation
Effects of Smartphone Use at Night with Light Emitting Diode Display With and Without Blue Light in Healthy Adults: A Randomized, Double-blind, Cross-over, Placebo-controlled Comparison
Completed
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Notify MeKey information
Conditions
Age range
20 year–40 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(1) Healthy males 20-40 years of age who understood the study procedure and agreed to participate after being fully informed about the study were included.
Exclusion criteria
- psychiatric diseases according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria;15
- cognitive or neurological disorders;
- alcohol or substance abuse;
- unstable or serious medical illness;
- current use of psychoactive mediations including antidepressants, anxiolytics, neuroleptics, anticonvulsants, hypnotics, or stimulant medications;
- primary sleep disorder;
- habitual sleep onset earlier than 21:00 or later than 24:00;
- shift worker;
- travel across more than two time zones within 90 days of the study; and
- ophthalmologic disease during the study period.
Treatment and study plan
Primary outcomes
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Changes of serum melatonin
Time frame: serum melatonin levels were measured every 60 min from 7:00 PM on day 1 to 8:00 AM on day 2, from 7:00 PM on day 2 to 8:00 AM on day 3, and from 7:00 PM to 11:00 PM on day 3 for 3 days.
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Changes of serum cortisol
Time frame: cortisol levels were measured every 120 min from 7:00 PM on day 1 to 8:00 AM on day 2, from 7:00 PM on day 2 to 8:00 AM on day 3, and from 7:00 PM to 11:00 PM on day 3 for 3 days.
-
Changes of body temperature
Time frame: body temperature was measured every 120 min from 7:00 PM on day 1 to 8:00 AM on day 2, from 7:00 PM on day 2 to 8:00 AM on day 3, and from 7:00 PM to 11:00 PM on day 3 for 3days.
Secondary outcomes
-
profile of mood states(POMS)
Time frame: day 1,3
Mood was measured using the POMS,17 a well-validated self-report measure of mood states.
-
Epworth Sleepiness Scale(ESS)
Time frame: day 1,3
ESS18 is comprised of eight questions that query the subject's likelihood of dozing off or falling asleep in a particular situation that is commonly met in daily life.
-
Fatigue severity scale(FSS)
Time frame: day 1,3
The FSS20 is composed of 9 statements (items) that describe fatigue symptoms. Respondents select the most relevant level of agreement over the last week on a 7-point scale (1 strongly disagree; 7 strongly agree).
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continuous performance test(CPT)
Time frame: day1,3
Integrated visual-auditory CPTs were performed at days 1 and 3 by a psychologist who was an expert on cognitive tests
Sponsors and collaborators
Lead sponsor
Samsung Medical Center
Other
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2014
- First posted
- Feb 24, 2016
- Registry last updated
- Feb 24, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.