A Phase 2 interventional study of continuous positive airway pressure (CPAP) and Placebo-CPAP in Epilepsy, Sleep Apnea and Obstructive Sleep Apnea, sponsored by Vanderbilt University. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-21.
Sponsored by Vanderbilt University · Phase 2, Interventional, and Treatment
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.
Despite appropriate treatment with medications, individuals with epilepsy often continue to have seizures, and many suffer from excessive daytime sleepiness and poor quality of life. Evidence from case studies suggests that treatment of coexisting obstructive sleep apnea (OSA)-stoppage in breathing during sleep-can reduce the frequency of seizures in people with epilepsy that is resistant to antiepileptic medication.
In this study, individuals with symptoms of OSA and 2 or more seizures a month who meet study criteria will undergo polysomnography, a test that continuously monitors normal and abnormal physiological activity during sleep. Those individuals who test positive for OSA will be randomized to either therapeutic or placebo continuous positive airway pressure (CPAP)-a mask treatment for sleep apnea-for 10 weeks, during which time seizure frequency, daytime sleepiness, health-related quality of life, and CPAP compliance will be assessed.
1,423 studies on the registry are indexed under Apnea; 160 are open to participants now.
This study's enrollment of 68 is above the median of 51 across 966 interventional studies indexed under Apnea.
Browse Apnea studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
continuous positive airway pressure (CPAP)
Device: continuous positive airway pressure (CPAP)
Placebo-CPAP
Device: Placebo-CPAP
a mask treatment for sleep apnea
Placebo-CPAP
CPAP Adherence/Tolerance as Measured by Proportion of Nights Used
This measure quantifies how well patients use their CPAP. The standard unit of measurement is proportion of nights that the CPAP is used by a participant (total nights used/total nights the device could have been used), averaged across all participants . Data were downloaded by a card placed in the CPAP machine reflecting use over the entire 10 weeks.
Time frame: 10 weeks
Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP
Patients all received a CPAP machine which either delivered CPAP or provided the patient with placebo CPAP, which had the same sensation as receiving CPAP
Time frame: 10 weeks
Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea
The data presented below represent the number of participants who required only one night of baseline sleep study prior to randomization
Time frame: prior to randomization
This pilot clinical trial was conducted between September 2002 and July 2005 at University of Michigan, Cleveland Clinic, University of North Carolina at Chapel Hill, and Vanderbilt University, with a Data Coordinating Center at the University of Michigan. 68 participants were enrolled and 35 were randomized.
| Milestone | Placebo Continuous Positive Airway Pressure | Continuous Positive Airway Pressure |
|---|---|---|
| Started | 13 | 22 |
| Completed | 13 | 19 |
| Not completed | 0 | 3 |
| Withdrew: Withdrawal by subject | 0 | 3 |
This measure quantifies how well patients use their CPAP. The standard unit of measurement is proportion of nights that the CPAP is used by a participant (total nights used/total nights the device could have been used), averaged across all participants . Data were downloaded by a card placed in the CPAP machine reflecting use over the entire 10 weeks.
| proportion of nights used (total nights | Placebo Continuous Positive Airway Pressure | Continuous Positive Airway Pressure |
|---|---|---|
| CPAP Adherence/Tolerance as Measured by Proportion of Nights Used | 0.74 ± 0.24 | 0.66 ± 0.3 |
Patients all received a CPAP machine which either delivered CPAP or provided the patient with placebo CPAP, which had the same sensation as receiving CPAP
| participants | Continuous Positive Airway Pressure (CPAP) | Placebo-CPAP |
|---|---|---|
| Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP | 22 | 13 |
The data presented below represent the number of participants who required only one night of baseline sleep study prior to randomization
| Participants | All Participants Prior to Randomization |
|---|---|
| Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea | 39 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Continuous Positive Airway Pressure | — | 0/13 (0%) | 2/13 (15.4%) |
| Continuous Positive Airway Pressure | — | 0/22 (0%) | 5/22 (22.7%) |
| Event | Placebo Continuous Positive Airway Pressure | Continuous Positive Airway Pressure |
|---|---|---|
| skin irritationSkin and subcutaneous tissue disorders | 0/13 | 2/22 |
| tachycardia or chest tightnessCardiac disorders | 1/13 | 1/22 |
| anxietyPsychiatric disorders | 1/13 | 0/22 |
| nasal congestionEar and labyrinth disorders | 0/13 | 1/22 |
| GI discomfortGastrointestinal disorders | 0/13 | 1/22 |
| Age, Categorical(Participants) | Placebo Continuous Positive Airway Pressure | Continuous Positive Airway Pressure | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 22 | 35 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Placebo Continuous Positive Airway Pressure | Continuous Positive Airway Pressure | Total |
|---|---|---|---|
| Mean | 40.2 ± 14.3 | 42.7 ± 12.3 | 41.8 ± 12.9 |
| Sex: Female, Male(Participants) | Placebo Continuous Positive Airway Pressure | Continuous Positive Airway Pressure | Total |
|---|---|---|---|
| Female | 7 | 8 | 15 |
| Male | 6 | 14 | 20 |
| Region of Enrollment(participants) | Placebo Continuous Positive Airway Pressure | Continuous Positive Airway Pressure | Total |
|---|---|---|---|
| United States | 13 | 22 | 35 |
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University