Nonorganic Insomnia clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT02694003 Active, not recruiting - Clinical trials for Neurodevelopmental Disorders

Better Nights, Better Days for Children With Neurodevelopment Disorders

BNBD-NDD

Start date: June 10, 2019
Phase: N/A
Study type: Interventional

More than 90% of children with neurodevelopmental disorders (NDD) experience sleep problems, whereas less than 25% of typically developing children experience sleep problems. Poor sleep can have significant consequences for children's physical and psychosocial health, as well their caregivers' well-being. The impact of sleep problems on daytime functioning is even greater in children with NDD. Although there are a range of factors that may disturb sleep in children with NDD, the most frequent cause of sleep disturbance is behavioural insomnia. There is some evidence that behavioural interventions can be effective in improving sleep in children with NDD. However, this has not been tested through well-designed, large-scale randomized controlled trials (RCTs). Moreover, there are a number of significant barriers to access for insomnia treatment for children; most importantly, sleep interventions are often only provided by specialists, limiting access to treatment services. Instead, behavioural insomnia is often treated with advice about sleep hygiene and with the supplement melatonin, which is, at best, a short-term solution. The investigators, an interdisciplinary team of researchers, will develop and evaluate the effectiveness of an online sleep intervention that will be widely accessible and sustainable and will have the potential to dramatically improve the health of children with NDD and their families.