| Study name |
Investigating the relationship between sleep disturbance and learning in children with Benign Epilepsy of Childhood with Centrotemporal Spikes (BECCTS): a randomised double blind placebo controlled crossover trial |
| Methods |
Randomised, double‐blind, placebo‐controlled, cross‐over trial. Six‐week treatment period (period A), followed by two‐week washout period, followed by six weeks of alternate treatment (period B) |
| Participants |
Inclusion criteria
Male and female children six to 16 years of age Within six months of diagnosis with BECCTS and onset of symptoms With clinical electroencephalographic (EEG) characteristics consistent with typical BECCTS With no current or prior treatment for BECCTS Signed informed (parental) consent
Exclusion criteria
Inability to comply with assessments Any serious intercurrent illness or uncontrolled disease that could compromise participation in the study With contraindications for treatment with sulthiame
History of hypersensitivity to sulphonamides History of acute porphyria History of hyperthyroidism History of arterial hypertension Impaired renal function Psychiatric disorder Hereditary galactose intolerance, Lapp lactase deficiency, glucose‐galactose malabsorption syndrome
|
| Interventions |
Sulthiame versus placebo |
| Outcomes |
Frequency of interictal epileptic discharges (IEDs) during slow wave sleep (SWS) on active treatment, relative to placebo, as measured by EEG at baseline, end of treatment period A and end of treatment period B Sleep quality (efficiency, number of awakenings, density of sleep spindles and percentage rapid eye movement (REM) and percentage SWS on polysomnography) on active treatment relative to placebo, as measured at baseline, end of treatment period A and end of treatment period B Performance on consolidation of learning (CoL) tasks on active treatment, relative to placebo, as measured (by validated CoL tools) at baseline, end of treatment period A and end of treatment period B Performance on cognitive assessments including IQ and event‐related potential (ERP) utilising the commonly employed auditory oddball paradigm as a measure of basic sensory processing and attention, as measured at baseline, end of treatment period A and end of treatment period B |
| Starting date |
13 July 2011 |
| Contact information |
finbar.ocallaghan@bristol.ac.uk |
| Notes |
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