None listed
Conditions
Brief summary
The purpose of this study is to evaluate the impact of treating concurrent, previously unrecognised obstructive sleep apnoea in patients with treatment resistant epilepsy. The primary outcome is the impact of treatment on seizure control, with secondary outcomes including quality of life and sleep measures, cognitive outcomes, psychiatric outcomes, and biomarkers of neurological injury
Interventions
Patients will be treated with continuous positive airway pressure therapy.
This involves the use of a face-mask and pump, supplying room air, overnight. Patients will be asked to use CPAP therapy for a minimum of four hours per night, on seven nights per week. CPAP therapy will be delivered at home, and the pressure, humidity and other settings will be individually adjusted per patient. Patients will be instructed in the use of their machine by the treating clinical team. Compliance with CPAP th
Patients will be treated with continuous positive airway pressure therapy. This involves the use of a face-mask and pump, supplying room air, overnight. Patients will be asked to use CPAP therapy for a minimum of four hours per night, on seven nights per week. CPAP therapy will be delivered at home, and the pressure, humidity and other settings will be individually adjusted per patient. Patients will be instructed in the use of their machine by the treating clinical team. Compliance with CPAP therapy will be assessed using a digital download from the device at the specified time points within the trial.
Sponsors
Department of Neurology, The Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients must have a diagnosis of untreated moderate or severe obstructive sleep apnoea on polysomnography. Patients must have a diagnosis of pharmacoresistant epilepsy on video-electroencephalography. Patients must tolerate more than four hours of CPAP therapy for 3 nights, in a one week APAP trial, and be willing to continue on CPAP therapy.
Exclusion criteria
Patients who are not aware of their seizures. Patients who are already effectively treated for obstructive sleep apnoea, or who refuse CPAP therapy. Patients who are unable to provide informed consent.
Outcome results
None listed