NCT03688984

Treatment of Insomnia for Adolescents With Mild Traumatic Brain Injury

Completed NA Last updated 28 September 2018

What this trial tests

NA trial testing Cognitive Behavioural Therapy for Insomnia in Mild Traumatic Brain Injury in 24 participants. Completed in 17 January 2018.

Timeline

1 September 2016

Primary endpoint
17 January 2018

17 January 2018

Quick facts

Lead sponsor	University of Calgary
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	24
Start date	1 September 2016
Primary completion	17 January 2018
Estimated completion	17 January 2018
Sites	1 location across Canada

Drugs / interventions tested

• Cognitive Behavioural Therapy for Insomnia

Conditions studied

• Mild Traumatic Brain Injury — all drugs for Mild Traumatic Brain Injury →
• Post-Concussion Syndrome — all drugs for Post-Concussion Syndrome →
• Insomnia — all drugs for Insomnia →

Sponsor

University of Calgary

Who can join

Adults 12 to 18, any sex, with Mild Traumatic Brain Injury or Post-Concussion Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A substantial number of children and adolescents sustain a mild traumatic brain injury (mTBI) each year. Although research supports that the vast majority of youth will recover quickly and return to normal functioning, some adolescents continue to report problems long after the injury. Disturbed sleep, notably trouble with sleep onset and sleep maintenance, is a frequently reported problem in those with slow recovery from a mTBI. Poor sleep is also associated with cognitive complaints, mood disturbance, and lower quality of life. Despite the identification of sleep disturbance as a problem associated with slow recovery, there are very few treatment options. Cognitive-behavioural therapy for insomnia (CBT-I) has shown promise in children and adolescents as an effective treatment for sleep disturbance, although it has yet to be applied to the adolescent mTBI population who also present with sleep problems. The objective of this study is to examine the treatment of sleep disturbance using cognitive-behavioural therapy for insomnia (CBT-I) in those adolescents who have a protracted recovery from their mTBI. This represents a novel treatment option for this patient population and is anticipated to improve outcomes and quality of life.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.