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Intra-individual variability in Dim Light Melatonin Onset in adults with ADHD and delayed sleep phase syndrome

Intra-individual variability in Dim Light Melatonin Onset in adults with ADHD and delayed sleep phase syndrome - DLMO in adults with ADHD and delayed sleep phase syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON33409
Enrollment
24
Registered
2009-05-26
Start date
2010-07-10
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Interventions

None listed

Sponsors

Parnassia (Den Haag)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)