CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
continuous positive airway pressure (CPAP) +1 moredevice
Likely dose
Continuous positive airway pressure (CPAP) — specific device settings not specifiedAI-extracted
Key inclusion· 5
  • ✓Age 18 years or older
  • ✓History supportive of obstructive sleep apnea
  • ✓Four or more quantifiable seizures per month
  • ✓Antiepileptic medication regimen optimized to therapeutic benefit prior to baseline
Key exclusion· 12
  • ✕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 other primary sleep disorder requiring medication intervention that may affect study results
  • ✕Effectively treated OSA or prior exposure to CPAP

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00047463
NCT00047463Phase 2Completed
CompareCT.gov

Effects of Treating Obstructive Sleep Apnea in Epilepsy

Vanderbilt University·interventional·Posted Oct 8, 2002·Updated Jul 21, 2016

In Brief

A Phase 2 clinical trial evaluating continuous positive airway pressure (CPAP) and Placebo-CPAP for Epilepsy and 2 related conditions. Completed, enrolled 68 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Sleep Apnea, Obstructive Sleep Apnea
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 8, 2002
Enrollment StartSep 1, 2002
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 23.7 years ago

Interventions

continuous positive airway pressure (CPAP)device

a mask treatment for sleep apnea

Placebo-CPAPdevice

Placebo-CPAP