Sleep InsufficiencyNCT05808179
Shifting Sleep Timing in Teens
A study testing Light and CBT in people with Sleep Insufficiency and Sleep, run by Stanford University at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine whether a combination of a novel lighting intervention and a behavioral intervention are able to increase total sleep time in adolescents. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Insufficiency, Sleep, Adolescent Behavior
- What is being tested?
- Light and CBT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 30 Jun 2027
- Phase
- Interventional
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 14-18 and a full-time student in grades 9-12
- Male or female
- Willing and with a schedule permitting them to go to bed at an earlier time
- Planning on sleeping at home in their bedroom for at least 75% of the study
Who cannot join
- Currently taking any medications (including over-the-counter medications, e.g., melatonin) specifically for the treatment of sleep disorders
- Sleep only in the prone (face-down) position
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Passive Phototherapy to Improve Sleep in Teens
The goal of this clinical trial is to determine whether a combination of a novel lighting intervention and a behavioral intervention are able to increase total sleep time in adolescents. The main questions this trial aims to answer are whether this combination therapy is able to meaningfully increase total sleep time in adolescents, and do so over a sustained period of time, and whether such a changes is associated with concomitant changes in mood and cognitive performance.
- Conditions
- Sleep Insufficiency, Sleep, Adolescent Behavior
- Being tested
- Light, CBT, Sham Light
- Medical subject headings
- Sleep Deprivation, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LightDevice
Broad-spectrum white light flashes are ~4000 lux, 2 msec long, occur every 20 s
CBTBehavioural
Cognitive behavioral therapy including psychoeducation, sleep hygiene, stimulus control, activity scheduling, motivational interviewing
Sham LightDevice
Broad-spectrum white light flashes are ~4000 lux, 2 msec long, occur once
| Study group | Role | What they receive |
|---|---|---|
| Light + Cognitive Behavioral Therapy (CBT) | Experimental | 1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy Receives: Device: Light; Behavioral: CBT |
| Sham light + CBT | Active comparator | 1 hour of sham light flashes (one flash) and cognitive behavioral therapy Receives: Behavioral: CBT; Device: Sham Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time
Average nightly total sleep time
Measured: 20 weeks
Secondary outcomes (2)
Melatonin timing
Timing of the onset of salivary melatonin
Measured: 8 weeks
Mood
Score on the Center for Epidemiologic Studies Depression Scale for Children. Scored 0-60 with higher scores indicating greater depressive symptomatology.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Jul 2022
- Primary completion20 Jun 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep InsufficiencyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 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
- NCT05808179
- Sponsor's protocol ID
- 1R01HD102344
- Status last verified
- Sep 2026
- First submitted
- 29 Mar 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be made freely available on Dryad.com. Study protocol, analysis plan, consent form (unsigned), and analytic code will be made available upon request.
Publications
Keskinel D, Karan M, Kaplan KA, Mirchandaney R, Asarnow L, Zeitzer JM. Piloting a brief digital behavioral intervention for adolescent sleep. Sleep Sci Pract. 2025;9(1):34. doi: 10.1186/s41606-025-00157-4. Epub 2025 Oct 31.
PubMed 41180604
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Phototherapy to Improve Sleep in Teens
- ClinicalTrials.gov ID
- NCT05808179
- Acronym / sponsor ID
- 1R01HD102344
- Conditions
- Sleep Insufficiency, Sleep, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Apr 2023 (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.
The goal of this clinical trial is to determine whether a combination of a novel lighting intervention and a behavioral intervention are able to increase total sleep time in adolescents. The main questions this trial aims to answer are whether this combination therapy is able to meaningfully increase total sleep time in adolescents, and do so over a sustained period of time, and whether such a changes is associated with concomitant changes in mood and cognitive performance.
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 + Cognitive Behavioral Therapy (CBT) | Experimental | Device: Light, Behavioral: CBT1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy |
| Sham light + CBT | Active comparator | Behavioral: CBT, Device: Sham Light1 hour of sham light flashes (one flash) and cognitive behavioral therapy |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 14-18 and a full-time student in grades 9-12
- Male or female
- Willing and with a schedule permitting them to go to bed at an earlier time
- Planning on sleeping at home in their bedroom for at least 75% of the study
Key exclusion criteria (2 listed)
- Currently taking any medications (including over-the-counter medications, e.g., melatonin) specifically for the treatment of sleep disorders
- Sleep only in the prone (face-down) position
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 |
|---|---|---|
| LightBroad-spectrum white light flashes are ~4000 lux, 2 msec long, occur every 20 s | Device | Light + Cognitive Behavioral Therapy (CBT) |
| CBTCognitive behavioral therapy including psychoeducation, sleep hygiene, stimulus control, activity scheduling, motivational interviewing | Behavioural | Light + Cognitive Behavioral Therapy (CBT), Sham light + CBT |
| Sham LightBroad-spectrum white light flashes are ~4000 lux, 2 msec long, occur once | Device | Sham light + CBT |
Primary outcome
Total sleep time
Time frame: 20 weeks
Average nightly total sleep time
2 secondary outcomes
Melatonin timing
Time frame: 8 weeks
Mood
Time frame: 20 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 25 Sep 2026.
- Derived from this study: PubMed 41180604Keskinel D, Karan M, Kaplan KA, Mirchandaney R, Asarnow L, Zeitzer JM. Piloting a brief digital behavioral intervention for adolescent sleep. Sleep Sci Pract. 2025;9(1):34. doi: 10.1186/s41606-025-00157-4. Epub 2025 Oct 31.
- Individual participant dataSharing planned: Yes. Deidentified data will be made freely available on Dryad.com. Study protocol, analysis plan, consent form (unsigned), and analytic code will be made available upon request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light and CBT in people with Sleep Insufficiency and Sleep, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. 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. 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?
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?
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?
Total sleep time (time frame: 20 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 NCT05808179, which also lists 1 linked publication.
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 25 Sep 2026.