BACKGROUND: Insomnia is a common complaint following chronic traumatic brain injury (TBI), with a prevalence rate ranging from 30 to 70%. Sleep disturbances such as insomnia may be associated with delayed recovery and poor quality of life in TBI patients. However, studies exploring effective interventions for insomnia in chronic TBI patients are lacking. PURPOSES: The purposes of this study are to develop treatment protocols of sensorimotor rhythm (SMT) neurofeedback and respiratory sinus arrhythmia (RSA) biofeedback for insomnia and to test their efficacy and possible mechanisms for improving sleep in patients with chronic TBI. METHODS: This 3-year study is a single blind, randomized controlled trial with a three-arm parallel-group design. Eighty-four chronic TBI patients with insomnia will be randomly allocated to the SMR group, RSA group or control group. Both SMR and RSA trainings consist of 10 one-hour sessions, once a week, over a 10-week period. The control group will receive usual care and telephone-interview support during the same period. Primary outcome variables include sleep quality and insomnia severity measured by using the Chinese version of Pittsburgh Sleep Quality Index and the Insomnia Severity Index-Chinese version, respectively. Secondary outcomes include sleep variables and quality of life measured by using the sleep logs and Quality of Life after Brain Injury scale. Heart rate variability and cognitive function tasks will also be examined to unveil the mechanisms underlying the effects of RSA biofeedback and SMR neurofeedback for insomnia. Data will be examined by analysis of variance (ANOVA), repeated measures ANOVA, and Pearson’s correlation coefficients. EXPECTED OUTCOME: The results from this study will inform nurses and TBI patients regarding the efficacy and mechanisms, if any, of neurofeedback and biofeedback for improving sleep quality.
|Effective start/end date||8/1/15 → 7/31/16|
- Chronic traumatic brain injury