Phase 4
Completed N=40
Randomized Controlled Trial on the Treatment Effects of Melatonin and Light Therapy on Delayed Sleep Phase Syndrome
Delayed Sleep Phase Syndrome
Source: ClinicalTrials.gov NCT00834886 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.