The objectieve of this study is to gain insight into the effect of methylphenidate on sleep and the circadian rhythm in adults with ADHD.
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
DLMO (Dim light melatonin onset)
Circadian actografic parameters
PAD (phase angle difference)
Secondary outcome
subjective sleepparameters measured with self reporting lists
Background summary
Previous studies showed that sleep problems are common in adults with ADHD.
Treatment with methylphenidate treatment leads to later bedtime and a longer
sleep time. However, the methylphenidate-treated patients with ADHD are less
likely to wake during the night and reported improved sleep quality.
Falling asleep late may indicate a disturbance of the biological clock,
characterized by delayed endogenous melatonin production (DLMO). There is only
one study in adults and in one in children which looked at the effect of
methylphenidate on the circadian rhythm. These studies show a delayed circadian
measured with actigraphy. To understand the effect of methylphenidate in adults
with ADHD on the circadian rhythm, this study will not only focus on
actigraphic circadian parameters but also on the endogenous melatonin
production (DLMO).
This pilot aims to answer the question whether improved sleep, or even worse
sleep through the use of methylphenidate is caused by shifting of the circadian
rhythm. Maybe in the future before the start of treatment, measuring the DLMO
could give a prediction about the effect of methylphenidate on sleep in adults
with ADHD.
Study objective
The objectieve of this study is to gain insight into the effect of
methylphenidate on sleep and the circadian rhythm in adults with ADHD.
Study design
Open pilot study
Study burden and risks
The burden for the subjects in time is 185 minutes (questionnaires, DLMO ,
blood samples, actography. Except for increased risk of hematoma through blood
tests, the risks are negligible.
Willy Brandtlaan 20
6716 RR Ede
NL
Willy Brandtlaan 20
6716 RR Ede
NL
Listed location countries
Age
Inclusion criteria
Adult ADHD patients between 21-60 years old
Exclusion criteria
Use of medication which influences sleep and/or the endogenous melatonin production
recent traveling within more than one time zone or participation in shift work
Substance abuse
Contraindications for the use of methylphenidate
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38784.091.11 |