The main objective of the study is to determine a delayed DLMO in adults with ADHD and delayed sleep phase syndrome compared to a group healthy persons.The second objective is to determine intra-individual variability in the group of participants…
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The DLMO will be compared between adults with ADHD and delayed sleep phase
disorder, and healthy volunteers;
- specific comparison of variability of the DLMO in saliva on 5 consecutive
days;
- the rhythm of body skin temperature and the melatonin production in the
patients and controls;
- results of sleepparameters such as: bed-time, sleep onset, sleep latency,
wake-up time, get up time and total sleep duration in hh:mm.
Secondary outcome
- correlation between individual parameters such as: gender, age, weight,
length, subtype ADHD, daylength at time of measurement, DLMO, body skin
temperature-curve, severity of ADHD, actigraph data;
- actigraph data: among others number of wake bouts, level of activity in least
active period, variation in SO/WT-time per day and between different days in
research period.
Background summary
ADHD in adults with delayed sleep phase syndrome (DSPS) has only been
investigated to a modest extent, with a lot of possibilities for future
research. In recent publications on adults with ADHD and delayed sleep phase
syndrome a relationship was found with a circadian rhythm disorder. It was
shown that there was a delayed onset of melatonin production (Dim Light
Melatonin Onset or DLMO) in patients compared to controls, a finding that could
be consistent with DSPS: a clinical diagnosis of a chronic sleep onset insomnia
in which there is a delayed sleep-wake rhythm in subjects with a normal sleep
pattern. Unknown is whether there is a intra-individual variablilty in DLMO
determined on consecutive nights in subjects with a delayed DLMO, or whether
this is constantly delayed. Clinical observation is consistent with the former,
although this has not yet been proven. It is important to know if there is
variability in the DLMO for both further research and treatment of ADHD and
DSPS. If there is intra-individual variability in the DLMO a single measurement
of the DLMO will suffice, which is the current procedure in most studies
conducted in this area. In this study the DLMO will be measured on five
consecutive nights to determine if there is intra-individual variability in the
DLMO.
Study objective
The main objective of the study is to determine a delayed DLMO in adults with
ADHD and delayed sleep phase syndrome compared to a group healthy persons.
The second objective is to determine intra-individual variability in the group
of participants with a delayed DLMO.
Study design
Observational research without invasive measurements.
Study burden and risks
Risks are minimal. The burden consists of 6 visits to the clinic. Each visit
has a mean duration of 15 minutes.
Carel Reinierszkade 197
2593 HR Den Haag
NL
Carel Reinierszkade 197
2593 HR Den Haag
NL
Listed location countries
Age
Inclusion criteria
ADHD and delayed sleep phase syndrome has been diagnosed according to regular clinical diagnostic procedures
Age 18-55
Patient/participant is able to read and understand Patient Information
Patient/participant has signed Informed Consent Form
Patient/participant is able and willing to meet follow up appointments for the study
Exclusion criteria
A-Comorbid disorder (Axis I) that is very severe at intake and that may interfere with need of rapid treatment or with the goals of the study:
Psychosis
Depressive disorder
Anxiety disorder
Current substance abuse or substance dependence (alcohol: more than 2 consumptions per day or for women more than 15 consumptions in total per week or for men more than 21 consumptionsin total per week. Cannabis and hard drugs: exclusion per se)
- Use of the following medications within a month prior to participation to the study: stimulants, anti-depressive medication, melatonin, anti-psychotic medication, clonidine, benzodiazepines, beta-blockers
- symptoms of dementia , anamnestic disorders or other cognitive disorders
- mental retardation
- insufficient fluency in the Dutch language
-shift working (evening or night) or traveling in 2 timezones within two weeks prior to participation to the study
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 | NL27699.097.09 |