Skip to content

A Study on the Changes of the Biological Rhythm by Display Image Modulation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02690311
Enrollment
22
Registered
2016-02-24
Start date
2013-08-31
Completion date
Unknown
Last updated
2016-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Rhythm Phase Shift

Brief summary

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

Interventions

DEVICEsmartphone display

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

1. psychiatric diseases according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria;15 2. cognitive or neurological disorders; 3. alcohol or substance abuse; 4. unstable or serious medical illness; 5. current use of psychoactive mediations including antidepressants, anxiolytics, neuroleptics, anticonvulsants, hypnotics, or stimulant medications; 6. primary sleep disorder; 7. habitual sleep onset earlier than 21:00 or later than 24:00; 8. shift worker; 9. travel across more than two time zones within 90 days of the study; and 10. ophthalmologic disease during the study period.

Design outcomes

Primary

MeasureTime frame
Changes of serum melatoninserum 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.
Changes of serum cortisolcortisol 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 temperaturebody 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

MeasureTime frameDescription
profile of mood states(POMS)day 1,3Mood was measured using the POMS,17 a well-validated self-report measure of mood states.
continuous performance test(CPT)day1,3Integrated visual-auditory CPTs were performed at days 1 and 3 by a psychologist who was an expert on cognitive tests
Epworth Sleepiness Scale(ESS)day 1,3ESS18 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)day 1,3The 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026