Phase 2
Completed N=35
Effects of Treating Obstructive Sleep Apnea in Epilepsy
Source: ClinicalTrials.gov NCT00047463 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: CPAP Adherence/Tolerance as Measured by Proportion of Nights Used — 0.74; 0.66 proportion of nights used (total nights — p=0.26
Summary
The purpose of this trial is to work out design issues prior to conducting a definitive phase 3 trial to determine whether treating sleep-related breathing disorders in people with epilepsy results in improvement in seizure control or an improvement in alertness during the day.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CPAP Adherence/Tolerance as Measured by Proportion of Nights Used |
0.74; 0.66 | 0.26 |
| SECONDARY Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP |
22; 13 | — |
| SECONDARY Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea |
39 | — |
Eligibility Criteria
Inclusion Criteria
- Age of 18 years or older.
- A history supportive of obstructive sleep apnea.
- Subject is able and willing to provide informed consent and to cooperate with polysomnography.
- Four or more quantifiable seizures per month.
- Subjects and their physicians agree to have their medication regimens optimized so that they are on the best regimen titrated to therapeutic benefit prior to the baseline phase of the study.
Exclusion Criteria
- Seizures secondary to drugs, alcohol, infection, neoplasia, demyelination, metabolic illness, or progressive degenerative disease.
- Non-epileptic spells (e.g., pseudoseizures) alone or in combination with epileptic seizures.
- Narcolepsy or another primary sleep disorder that requires intervention with medications and which may affect results of study (e.g., severe periodic limb movement disorder).
- Effectively treated OSA or prior exposure to continuous positive airway pressure.
- History of poor compliance with antiepileptic medications.
- Current treatment with the vagus nerve stimulator.
- Pregnancy.
- A significant history of medical or psychiatric disease which may impair participation in the trial.
- A history of alcohol or drug abuse during the one-year period prior to trial participation.
- Evidence of medical instability (e.g., congestive heart failure, cardiac arrhythmias, pulmonary disease) due to obstructive sleep apnea.
- Subjects who are unaware of the majority of their seizures and lack a reliable witness.
- Greater than ten seizures a day.
Data sourced from ClinicalTrials.gov (NCT00047463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.