To investigate the effect of sleep treatment on ADHD, mood and sleep quality.
ID
Source
Brief title
Condition
- Other condition
- Sleep disorders and disturbances
Synonym
Health condition
ADHD
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Each intervention is evaluated for its effect on the reduction of self-reported
and objective ADHD symptoms, mood symptoms, and sleep quality. Treatment of
sleep is hypothesized to lead to a reduction of ADHD symptoms. The combined
treatment of sleep and ADHD is expected to have the highest effect on ADHD.
Secondary outcome
The data will give insight into any treatment effect on the objective PSG
signals, and also a cluster analysis for sleep and ADHD will be possible in
order to examine if sleep parameters are related to behavioural or psychiatric
aspects in ADHD.
Background summary
Attention-deficit/hyperactivity disorder (ADHD) is highly associated with a
delayed circadian rhythm, which is prevalent in 73-78% of children and adults
with ADHD. Also sleep disorders such as restless legs syndrome,
sleep-disordered breathing, and insomnia are increased in ADHD. The
persistence of ADHD symptoms from childhood into adulthood is even predicted by
sleep problems. Sleep problems are currently seldom diagnosed and treated in
psychiatry. Sleep problems increase cognitive symptoms of ADHD. Treating sleep
problems is hypothesized to decrease the severity of ADHD.
Study objective
To investigate the effect of sleep treatment on ADHD, mood and sleep quality.
Study design
Open-label randomized controlled trial
Intervention
Participants have a routine sleep screening using the HSDQ. After a positive
screen, they are asked to participate. Participation means clinical assessment
and polysomnography (PSG) at home. Then, they are randomized for a 12-week
intervention of (1) a protocolled sleep treatment for their sleep disorder
aimed at improving the sleep, irrespective of the underlying sleep disorder;
(2) treatment as usual (TAU) for ADHD consisting of psyco-education, coaching,
pharmacological therapy,, aimed to improving the ADHD and daily functioning; or
(3) a combined treatment of sleep and TAU. At three time points the ADHD
symptoms, sleep and mood are evaluated objectively and subjectively.
Study burden and risks
The participants will have standard screening for sleep disorders and
diagnostic assessment for sleep disorders using home-PSG. To have the PSG at
home is more comfortable than in a sleep lab, as is currently the common
practice. For the current study, the home-PSG is equally valuable as lab-PSG.
The sleep treatments in case of a sleep diagnosis is standard treatment for
those with sleep disorders. TAU for ADHD does not include sleep treatment. The
combined treatment for sleep and ADHD is novel in the current study. The burden
for the participants is regarded to be low as each of the three interventions
involves regular treatment for their assessed sleep disorder and ADHD. For the
current study, the participants fill out a set of questionnaires and do the
computerized objective QbTest (for the severity of ADHD symptoms) at three time
points (3 x 40 minutes); wear an actometer (measuring sleep and wake) during a
week at two time points; and have an second (re-test) home-PSG at the end of
the intervention period. The assessments are non-invasive.
Carel Reinierszkade 197
Den Haag 2593 HR
NL
Carel Reinierszkade 197
Den Haag 2593 HR
NL
Listed location countries
Age
Inclusion criteria
Age 18-50 years, diagnosed ADHD (or ADD), understanding of the Dutch language,
a positive screening on the HSDQ for at least one of the following sleep
disorders: DSPS, RLS / PLMS, sleep-disordered breathing, and/or insomnia.
Exclusion criteria
Comorbid disorders that require immediate treatment, psychotic disorder, mental
retardation, pregnancy or active wish to conceive (in females), use of ADHD or
sleep medication in the prior month, history of sleep treatment, and any
morbidity affecting sleep (e.g. diabetes).
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68572.058.18 |
| OMON | NL-OMON20912 |