ADHD Delayed sleep phase syndrome
Conditions
Interventions
Baseline (week 1)
All patients fill out questionnaires about demographic characteristics, sleep
characteristics (MCTQ), ADHD symptoms (ADHD-RS), life style, daytime
sleepiness, any illness or colds
during 1 night the salivary
melatonin will be assessed between 8 PM and 3 AM on the hour, during 1 morning
salivary cortisol will be assessed (directly after wake-up, 15 minutes, and 30
minutes aft
and the assessment of blood pressure, length and weight.
Randomisation and intervention (weeks 2-4)
patients will be randomised for one
of the following interventions:
1) Sleep education plus 0,5 mg dd Melatonin 3 hours before DLMO during 3 weeks
(MEL)
2) Sleep education plus 0,5 mg dd placebo 3 h
Sponsors
Parnassia Bavo Groep (Den Haag)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age between 18-55 years old - Diagnosis ADHD - Diagnosis DSPS
Exclusion criteria
Exclusion criteria: - Psychotic illness; - Untreated mood disorder; - Untreated anxiety disorder; - Alcohol intake > 2 U/day, or for women >15 U/week, for men >;21 U/week; - Use of cannabis; - Use of harddrugs; - Suspected dementia, anamnestic disorder of other cognitive disorder (DSM-IV); - Mental retardation; - Use of the following medication within 1 month prior to study participation: psychostimulants, melatonin, mirtazapin, sleep medication, antipsychotics, clonidin, benzodiazepins, bèta-blockers; - Insufficient fluency of the Dutch language; - Evening or night shift work; - Travel over > 2 time zones within 2 weeks prior to study participation (because of possible jet lag); - Pregnancy or breast feeding; - Having joung children who may disturb night rest;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The phase advance time of the DLMO (the moment that the natural melatonin production reaches the 3 pg/mL threshold in saliva) at Followup 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Improvement of the apetite profiles of hormones leptin and ghrelin - Improvement of insulin resistence - Improvement of biomarker profiles - Improvement of heart rate variability - Improvement of blood pressure and possibly weight - Prolongiation of the sleep duration, shortening of the sleep onset delay and the advancement of the wake-up time (as measured by Actigraphy) - Decrease of daytime sleepiness - Improvement of quality of life - Decrease of ADHD symptoms - Decrease of intake of carbonhydrate-rich food - Treatment satisfaction | — |
Countries
Netherlands
Outcome results
None listed