Delayed Sleep Phase DisorderPhase 4NCT01406691
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
A Phase 4 study testing Flashes in people with Delayed Sleep Phase Disorder, run by Stanford University at 1 site in United States.
Trial summary
Delayed Sleep Phase Disorder (DSPD) is a sleep disruption that commonly occurs in teens and manifests as a difficulty in waking up in the morning, going to sleep early enough at night, and daytime disturbances such as depression, fatigue, and restlessness. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Delayed Sleep Phase Disorder
- What is being tested?
- Flashes
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female
- Full-time in high school
- primary sleep complaint consistent with delayed sleep phase disorder
Who cannot join
- sleep only in prone position
- currently taking medications specifically for the treatment of a sleep disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94304
Jamie Zeitzer, PhD
Rafael Pelayo, MD
About this study
Official title: Treating Sleep Disruption in Teens With Millisecond Light Exposure During Sleep
Delayed Sleep Phase Disorder (DSPD) is a sleep disruption that commonly occurs in teens and manifests as a difficulty in waking up in the morning, going to sleep early enough at night, and daytime disturbances such as depression, fatigue, and restlessness. The purpose of this study is to determine if brief flashes of light, that are scheduled to occur during sleep, are effective in treating DSPD.
- Conditions
- Delayed Sleep Phase Disorder
- Being tested
- Flashes
- Keywords
- sleep, delayed sleep phase disorder, circadian, teen, adolescent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlashesDevice
one hour of a sequence of light flashes (4000 lux, 3 msec, every 30 seconds); occurs during the hour immediately prior to desired waketime
| Study group | Role | What they receive |
|---|---|---|
| Light | Experimental | one hour of a sequence of light flashes (4000 lux, 3 msec, every 30 seconds); occurs during hour immediately prior to desired waketime Receives: Device: Flashes |
| Fake light | Placebo comparator | during hour immediately prior to desired waketime, subjects will receive one light flash (insufficient to cause phase shift) Receives: Device: Flashes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Determined by questionnaire (Adolescent Sleep Wake Scale)
Measured: weekly for four weeks
Secondary outcomes (1)
Mood
Center for Epidemiologic Studies Depression Scale for Children (depressive symptoms) SNAP-IV 26 (ADHD symptoms)
Measured: at the begining and end of intervention (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startDec 2013
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Delayed Sleep Phase DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jamie M. Zeitzer, Ph.D., Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406691
- Sponsor's protocol ID
- kidflash
- Other IDs
- R01HD102344-01A1
- Status last verified
- Mar 2023
- First submitted
- 29 Jul 2011
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Zeitzer JM, Ruby NF, Fisicaro RA, Heller HC. Response of the human circadian system to millisecond flashes of light. PLoS One. 2011;6(7):e22078. doi: 10.1371/journal.pone.0022078. Epub 2011 Jul 8.
PubMed 21760955Zeitzer JM, Fisicaro RA, Ruby NF, Heller HC. Millisecond flashes of light phase delay the human circadian clock during sleep. J Biol Rhythms. 2014 Oct;29(5):370-6. doi: 10.1177/0748730414546532. Epub 2014 Sep 16.
PubMed 25227334Joyce DS, Spitschan M, Zeitzer JM. Optimizing Light Flash Sequence Duration to Shift Human Circadian Phase. Biology (Basel). 2022 Dec 13;11(12):1807. doi: 10.3390/biology11121807.
PubMed 36552316Joyce DS, Spitschan M, Zeitzer JM. Duration invariance and intensity dependence of the human circadian system phase shifting response to brief light flashes. Proc Biol Sci. 2022 Mar 9;289(1970):20211943. doi: 10.1098/rspb.2021.1943. Epub 2022 Mar 9.
PubMed 35259981Kaplan KA, Mashash M, Williams R, Batchelder H, Starr-Glass L, Zeitzer JM. Effect of Light Flashes vs Sham Therapy During Sleep With Adjunct Cognitive Behavioral Therapy on Sleep Quality Among Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911944. doi: 10.1001/jamanetworkopen.2019.11944.
PubMed 31553469
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Sleep Disruption in Teens With Millisecond Light Exposure During Sleep
- ClinicalTrials.gov ID
- NCT01406691
- Acronym / sponsor ID
- kidflash
- Conditions
- Delayed Sleep Phase Disorder
- Keywords
- sleep, delayed sleep phase disorder, circadian, teen, adolescent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Dec 2013 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 1 Aug 2011 (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.
Delayed Sleep Phase Disorder (DSPD) is a sleep disruption that commonly occurs in teens and manifests as a difficulty in waking up in the morning, going to sleep early enough at night, and daytime disturbances such as depression, fatigue, and restlessness. The purpose of this study is to determine if brief flashes of light, that are scheduled to occur during sleep, are effective in treating DSPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light | Experimental | Device: Flashesone hour of a sequence of light flashes (4000 lux, 3 msec, every 30 seconds); occurs during hour immediately prior to desired waketime |
| Fake light | Placebo comparator | Device: Flashesduring hour immediately prior to desired waketime, subjects will receive one light flash (insufficient to cause phase shift) |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female
- Full-time in high school
- primary sleep complaint consistent with delayed sleep phase disorder
Key exclusion criteria (2 listed)
- sleep only in prone position
- currently taking medications specifically for the treatment of a sleep disorder
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 |
|---|---|---|
| Flashesone hour of a sequence of light flashes (4000 lux, 3 msec, every 30 seconds); occurs during the hour immediately prior to desired waketime | Device | Fake light, Light |
Primary outcome
Sleep quality
Time frame: weekly for four weeks
Determined by questionnaire (Adolescent Sleep Wake Scale)
1 secondary outcome
Mood
Time frame: at the begining and end of intervention (4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Background: PubMed 21760955Zeitzer JM, Ruby NF, Fisicaro RA, Heller HC. Response of the human circadian system to millisecond flashes of light. PLoS One. 2011;6(7):e22078. doi: 10.1371/journal.pone.0022078. Epub 2011 Jul 8.
- Background: PubMed 25227334Zeitzer JM, Fisicaro RA, Ruby NF, Heller HC. Millisecond flashes of light phase delay the human circadian clock during sleep. J Biol Rhythms. 2014 Oct;29(5):370-6. doi: 10.1177/0748730414546532. Epub 2014 Sep 16.
- Background: PubMed 36552316Joyce DS, Spitschan M, Zeitzer JM. Optimizing Light Flash Sequence Duration to Shift Human Circadian Phase. Biology (Basel). 2022 Dec 13;11(12):1807. doi: 10.3390/biology11121807.
- Background: PubMed 35259981Joyce DS, Spitschan M, Zeitzer JM. Duration invariance and intensity dependence of the human circadian system phase shifting response to brief light flashes. Proc Biol Sci. 2022 Mar 9;289(1970):20211943. doi: 10.1098/rspb.2021.1943. Epub 2022 Mar 9.
- Results publication: PubMed 31553469Kaplan KA, Mashash M, Williams R, Batchelder H, Starr-Glass L, Zeitzer JM. Effect of Light Flashes vs Sham Therapy During Sleep With Adjunct Cognitive Behavioral Therapy on Sleep Quality Among Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911944. doi: 10.1001/jamanetworkopen.2019.11944.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flashes in people with Delayed Sleep Phase Disorder, run by Stanford University at 1 site in United States.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 24 Mar 2023. 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 United States. 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Zeitzer, PhD (650-493-5000 ext. 62410, jzeitzer@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: weekly for four 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 NCT01406691, which also lists 5 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 24 Mar 2023.