Status:
COMPLETED
Better Nights, Better Days for Typically Developing Children
Lead Sponsor:
IWK Health Centre
Conditions:
Nonorganic Insomnia
Primary Insomnia
Eligibility:
All Genders
1-10 years
Phase:
NA
Brief Summary
Up to 25% of children suffer from sleep problems categorized as "insomnia": difficulty settling, falling asleep, and staying asleep. This leads to daytime sleepiness and negatively effects behaviour, ...
Detailed Description
Rationale: Evidence demonstrates that behavioural interventions should be the first line of treatment for children with insomnia, but this is not typically the case. Evidence-based behavioural interv...
Eligibility Criteria
Inclusion
- Potential participants must meet the following criteria to be eligible to participate in the study:
- Primary caregiver of a child aged 1 to 10 years.
- Live in any province or territory in Canada.
- Have regular access to high speed internet connection and an email account.
- Comfortable communicating in English or French for day-to-day tasks (e.g., listening to the news on the radio or watching TV, reading books, magazines, etc.).
- Child has insomnia, defined as having Sleep Onset Disturbance. For Sleep Onset Disturbance, child must meet two of the following three criteria. These episodes must have been occurring for at least one month:
- 1\. More than three reunions for 12-24 month olds/more than two reunions for \>24 month olds that occur two or more nights per week 2. 30 or more minutes to fall asleep for 12-24 month olds/20 or more minutes to fall asleep for \>24 month olds 3. Parent remains in room for sleep onset for two or more nights per week
Exclusion
- Potential participants who meet any of the following criteria are not eligible to participate in the study:
- Parent wishes to "bed-share" with his/her child.
- Child has a probable intrinsic sleep disorder (e.g., sleep apnea) as assessed using the Pediatric Sleep Questionnaire (PSQ).
- Child has a significant medical disorder that interferes with sleep (e.g., asthma attacks during night, tube feeding, non-ambulatory, severe developmental disability affecting sensory systems such as vision).
- Child has a mental health disorder that has required hospitalization or residential care and/or current use of psychotropic medications which are known to interfere with sleep (e.g., stimulant medication for ADHD).
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
534 Patients enrolled
Trial Details
Trial ID
NCT02243501
Start Date
September 1 2016
End Date
October 1 2018
Last Update
April 8 2025
Active Locations (1)
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1
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 2R1