Effects of melatonin treatment, light therapy, and sleep improvement on psychosocial, cognitive, and behavioural outcomes in children with Delayed Sleep Phase Syndrome and their parents

Completed

• Conditions: slaapstoornissen/circadiane ritmiekstoornissen; delayed sleep phase syndrome; sleep onset insomnia

• Registration Number: NL-OMON39468
• Lead Sponsor: niversiteit van Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 192

Inclusion Criteria

- The child is between 7 and 12 years old,
and
- The child has chronic sleep onset problems, which is indicated by:
a. complaint of inability to fall asleep at the desired clock time (Sleep onset later than 20:45 h in children aged 7 years and for older children 15 minutes later per year until and including age 12, and a latency between lights-off time and sleep onset (sleep onset latency) of more than 30 minutes),
b.
the symptoms are present for at least 4 nights a week, for at least 1 month during a regular
school period,
and
- Dim Light Melatonin Onset (DLMO, the clock time at which the endogenous melatonin secretion reaches the threshold of 4 pg/ml) later than 19:45 h in children aged 7 years and for older children 15 minutes later per year until and including age 12,
and
- the sleep problems result in problems with daytime functioning . Children should have the following symptoms:
a) sleepiness/tiredness during the day
and at least one of the following:
b) external behaviour problems
c) internal behaviour problems
d) problems with functioning at school.

Exclusion Criteria

- pervasive developmental disorder
- chronic pain
- known disturbed hepatic or renal function
- Roter or Dubin-Johnson syndrome
- epilepsy
- use of stimulants, neuroleptics, benzodiazepines, clonidine, antidepressants, hypnotics, or *-blockers within 4 weeks before enrolment
- total IQ <80

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our primary endpoints are DLMO, sleep onset time, chronic sleep reduction,<br /><br>behaviour problems, and cognitive functioning. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Significant improvements on other variables measured with the questionnaires<br /><br>(attention problems, inhibitory control, mood, health, functioning at school,<br /><br>parental sleep, parenting stress, parenting) during and directly after<br /><br>treatment compared to baseline.</p><br>