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DELAYED SLEEP PHASE SYNDROME. SLEEP, PERSONALITY, DEVELOPMENTAL HISTORY, CIRCADIAN RHYTHM AND TREATMENT - DSPS in youth

DELAYED SLEEP PHASE SYNDROME. SLEEP, PERSONALITY, DEVELOPMENTAL HISTORY, CIRCADIAN RHYTHM AND TREATMENT - DSPS in youth

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005986-36-NO
Enrollment
60
Registered
2008-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed sleep phase syndrome - DSPS. MedDRA version: 9.1 Level: LLT Classification code 10012209 Term: Delayed sleep phase

Interventions

Trade Name: Nature´s One Melatonin Product Name: Melatonin Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use

Sponsors

University of Bergen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: - Severe to moderate psychopatholgy - Other sleep disturbances than DSPS (sleep apnoe, restless legs etc.) - Being pregnant/nursing

Design outcomes

Primary

MeasureTime frame
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):—

Countries

Norway

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026