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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Sham light + CBT | Active Comparator | 1 hour of sham light flashes (one flash) and cognitive behavioral therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light | Device | Broad-spectrum white light flashes are ~4000 lux, 2 msec long, occur every 20 s |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total sleep time | Average nightly total sleep time | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Melatonin timing | Timing of the onset of salivary melatonin | 8 weeks |
| Mood | Score on the Center for Epidemiologic Studies Depression Scale for Children. Scored 0-60 with higher scores indicating greater depressive symptomatology. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamie Zeitzer, PhD | Contact | 6504935000 | jzeitzer@stanford.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41180604 | Derived | 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. |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 18, 2023 | Apr 18, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| D000294 | Adolescent Behavior |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D014467 | Ultraviolet Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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| CBT | Behavioral | Cognitive behavioral therapy including psychoeducation, sleep hygiene, stimulus control, activity scheduling, motivational interviewing |
|
| Sham Light | Device | Broad-spectrum white light flashes are ~4000 lux, 2 msec long, occur once |
|
| 20 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D001519 | Behavior |