Circadian Rhythm Phase ShiftNCT02690311

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

A study testing smartphone display in people with Circadian Rhythm Phase Shift, run by Samsung Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 20 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Circadian Rhythm Phase Shift
What is being tested?: smartphone display
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: No sites listed yet
Study dates: Aug 2013to Jan 2014
Phase: Interventional
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 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 10Show fewer

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.

About this study

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

Conditions: Circadian Rhythm Phase Shift
Being tested: smartphone display

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

smartphone displayDevice

Study groups in NCT02690311
Study group	Role	What they receive
LED with bluelight	Sham comparator	Two types of smartphone were used. One type had a conventional LED display with the full range of blue light. The LED in the other type newly developed by Samsung Display was suppressed for the blue light portion of the spectrum (wavelength 450 ~ 470 nm). The smartphones were indistinguishable from each other with the naked eye, because other wavelengths mimicked blue light in the suppressed LED. Receives: Device: smartphone display
LED without bluelight	Experimental	Two types of smartphone were used. One type had a conventional LED display with the full range of blue light. The LED in the other type newly developed by Samsung Display was suppressed for the blue light portion of the spectrum (wavelength 450 ~ 470 nm). The smartphones were indistinguishable from each other with the naked eye, because other wavelengths mimicked blue light in the suppressed LED. Receives: Device: smartphone display

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes of serum melatonin
Measured: 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.
Changes of serum cortisol
Measured: 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
Measured: 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 (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Jan 2014

First posted24 Feb 2016 (estimated)
Study startAug 2013
Primary completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Circadian Rhythm Phase ShiftStudies of the same condition, open and under way.
More trials run by Samsung Medical CenterThe 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: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02690311
Sponsor's protocol ID: 2013-08-072
Status last verified: Aug 2013
First submitted: 28 Jan 2016
Last updated: 24 Feb 2016
Results posted: No

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study on the Changes of the Biological Rhythm by Display Image Modulation
ClinicalTrials.gov ID: NCT02690311
Acronym / sponsor ID: 2013-08-072
Conditions: Circadian Rhythm Phase Shift
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Samsung Medical CenterUniversity, hospital or other
Study start: Aug 2013
Primary completion: Jan 2014 (actual)
First posted: 24 Feb 2016 (estimated)
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.

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

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
LED with bluelight	Sham comparator	Device: smartphone displayTwo types of smartphone were used. One type had a conventional LED display with the full range of blue light. The LED in the other type newly developed by Samsung Display was suppressed for the blue light portion of the spectrum (wavelength 450 ~ 470 nm). The smartphones were indistinguishable from each other with the naked eye, because other wavelengths mimicked blue light in the suppressed LED.
LED without bluelight	Experimental	Device: smartphone displayTwo types of smartphone were used. One type had a conventional LED display with the full range of blue light. The LED in the other type newly developed by Samsung Display was suppressed for the blue light portion of the spectrum (wavelength 450 ~ 470 nm). The smartphones were indistinguishable from each other with the naked eye, because other wavelengths mimicked blue light in the suppressed LED.

Who may qualify

Ages: 20 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
smartphone display	Device	LED with bluelight, LED without bluelight

Primary outcome

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.
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.

4 secondary outcomes

profile of mood states(POMS)
Time frame: day 1,3
Epworth Sleepiness Scale(ESS)
Time frame: day 1,3
Fatigue severity scale(FSS)
Time frame: day 1,3
continuous performance test(CPT)
Time frame: day1,3

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 24 Feb 2016.

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing smartphone display in people with Circadian Rhythm Phase Shift, run by Samsung Medical Center.

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 10 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 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

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.). The study lists 3 primary outcomes in all. 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 NCT02690311.

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 24 Feb 2016.