Status:
COMPLETED
Sleep IntervEntion as Symptom Treatment for ADHD
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Research Foundation Flanders
KU Leuven
Conditions:
ADHD
Sleep
Eligibility:
All Genders
13-17 years
Phase:
NA
Brief Summary
Up to 72% of adolescents with ADHD portray sleep problems. The most common sleep difficulties in adolescents with ADHD are initial insomnia, nocturnal awakenings, non-restorative or restless sleep. Th...
Eligibility Criteria
Inclusion
- Attending secondary education and between 13-17 years old
- prior diagnosis of ADHD (any presentation) and confirmation of DSM-5 criteria of ADHD in current study
- Displaying sleep problems for at least 3 nights per week for at least 3 months
- sleep onset latency of at least 20-30 minutes
- and/or wake after sleep onset greater than 30 min
- and/or an average sleep time of less than 7 hours
- and at least one poor sleep hygiene practice
- and experienced distress as indicated by parent/guardian and/or adolescent.
- estimated IQ≥80
- stable ADHD medication use at least 4 weeks before start of treatment and no dose or medication type changes planned during active treatment
Exclusion
- the following comorbidities: sleep-breathing disorder, restless leg syndrome, narcolepsy, conduct disorder, depressive disorder with suicide risk or active suicidality, autism spectrum disorder, or substance use disorder, with an exception for nicotine
- acute crisis situation at home
- physical problems that interfere with sleep (e.g. pain) or medical disorders and related medication that could affect sleep
- participation in a behaviorally based sleep intervention in the 6 months prior to our study
- currently taking pharmacological medication for sleep (including melatonin), anxiety or depression. Participation will be allowed after a two-week wash-out period of the medication
Key Trial Info
Start Date :
January 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04723719
Start Date
January 28 2021
End Date
February 1 2024
Last Update
May 14 2024
Active Locations (1)
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1
UPC Leuven
Leuven, Vlaams Brabant, Belgium, 3000