DELAYED SLEEP PHASE SYNDROME. SLEEP, PERSONALITY, DEVELOPMENTAL HISTORY, CIRCADIAN RHYTHM AND TREATMENT - DSPS in youth
Phase 1
- Conditions
- Delayed sleep phase syndrome - DSPS.MedDRA version: 9.1Level: LLTClassification code 10012209Term: Delayed sleep phase
- Registration Number
- EUCTR2007-005986-36-NO
- Lead Sponsor
- niversity of Bergen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Age 16 to 19
- meet the criterions for DSPS
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Severe to moderate psychopatholgy
- Other sleep disturbances than DSPS (sleep apnoe, restless legs etc.)
- Being pregnant/nursing
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the efficacy of bright light therapy and melatonin treatment using a 4 armed placebo controlled design;Secondary Objective: To investigate which gives better efficacy on DSPS - melatonin, light therapy or both;Primary end point(s):
- Secondary Outcome Measures
Name Time Method