None listed
Conditions
Brief summary
The primary aim of the study is to test the usefulness of melatonin treatment in delayed sleep phase patients who present with delayed melatonin rhythms.
Interventions
Melatonin (0.5mg) will be adminstered via oral tablet day 1 hour prior to bedtime for a minimum of 5 nights per week for a duration of 4 weeks.
Sponsors
A/Prof Shantha Rajaratnam
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1) Aged 16 to 65 years (equal gender) 2) Body mass index >18 and < 30kg/m2 3)High risk of DSPD according to established criteria (scoring online or written survey) on the DSPD screening questionnaire 4) Five or more consecutive days each week in which the individual participates in day work or school 5) Self-reported willingness to go to bed at the desired bedtime (as determined by participants) 6) Able to abstain from tobacco and alcohol for the entire trial and caffeine late in the day.
Exclusion criteria
1) Comorbid sleep disorder (except insomnia) 2) Drugs of abuse or concurrent medication (including OTC medicines or herbal substances) likely to affect sleep (other than antidepressants) 3) History of psychiatric disorder in the past 12 months, other than depression 4) Caffeine consumption > 300mg per day 5) Alcohol consumption > 14 standard drinks per week 6) History of substance in the past 12 months 7) Investigational drug use in the past 60 days 8) Pregnancy or lactation 9) Night shift work in the past 6 months 10) Transmeridian travel in the past 2 months 11) Allergies to any medicines, foods, preservatives or dyes 12) Liver, kidney, or autoimmune disease
Outcome results
None listed