Phase 4
N=40
Randomized Controlled Trial on the Treatment Effects of Melatonin and Light Therapy on Delayed Sleep Phase Syndrome
Delayed Sleep Phase Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00834886 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: To Investigate the Efficacy on Rise Time of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. — 530; 506; 520; 543 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Melatonin (Dietary_supplement); Bright light (Other); Placebo red light (Other); Placebo capsule (Other)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- University of Bergen
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Investigate the Efficacy on Rise Time of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. |
530; 506; 520; 543 | — |
| PRIMARY To Investigate the Efficacy on Subjective Sleepiness of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. |
6.0; 5.9; 6.3; 6.5 | — |
| PRIMARY To Investigate the Efficacy on Sleep Onsel Latency of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests. |
11; 21; 15; 24 | — |
Summary
In this study the investigators will examine the effects of melatonin and light therapy on delayed sleep phase syndrome in adolescents 16 up to 20 years old. 60 subjects will be randomized into four different groups; melatonin + light therapy (N=15), melatonin + placebo light (N=15), placebo + light therapy (N=15) and placebo + placebo light. This is a double-blinded treatment and the participants will receive this treatment for 2 weeks. Then they will be re-randomized into two groups; full treatment with light therapy + melatonin (N=30) and no treatment (N=30) for 3 months unblinded. The investigators will test the subjects pre-treatment, post 2 week treatment and after 3 months.
Eligibility Criteria
Inclusion Criteria
- 16-25 years old
- lives in the Bergen area
- has Delayed Sleep Phase Disorder
Exclusion Criteria
- pregnant or nursing women
- other sleep disorders (i.e. sleep apnoea or PLMS)
- moderate to serious psychiatric disease
- use of psychopharmacological medicines
- in psychotherapeutic treatment
Data sourced from ClinicalTrials.gov (NCT00834886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.