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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NS042698-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP active comparator | Active Comparator | continuous positive airway pressure (CPAP) |
|
| CPAP Placebo | Placebo Comparator | Placebo-CPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous positive airway pressure (CPAP) | Device | a mask treatment for sleep apnea |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 weeks |
| Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth Malow, M.D., M.S. | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States | ||
| University of North Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18711110 | Result | Malow BA, Foldvary-Schaefer N, Vaughn BV, Selwa LM, Chervin RD, Weatherwax KJ, Wang L, Song Y. Treating obstructive sleep apnea in adults with epilepsy: a randomized pilot trial. Neurology. 2008 Aug 19;71(8):572-7. doi: 10.1212/01.wnl.0000323927.13250.54. | |
| 18513353 | Result | Selwa LM, Marzec ML, Chervin RD, Weatherwax KJ, Vaughn BV, Foldvary-Schaefer N, Wang L, Song Y, Malow BA. Sleep staging and respiratory events in refractory epilepsy patients: Is there a first night effect? Epilepsia. 2008 Dec;49(12):2063-8. doi: 10.1111/j.1528-1167.2008.01681.x. Epub 2008 May 29. |
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Epilepsy clinic patients initially meeting trial eligibility on the basis of chart review completed a validated instrument that assesses the likelihood of having obstructive sleep apnea, and underwent a sleep and epilepsy evaluation by the site investigator. 68 patients consented, 33 not randomized due to not meeting criteria or declined.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Continuous Positive Airway Pressure | With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open. |
| FG001 | Continuous Positive Airway Pressure | Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Continuous Positive Airway Pressure | With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | proportion of nights used (total nights | 10 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Continuous Positive Airway Pressure | With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tachycardia or chest tightness | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment | patient described a rapid heart rate |
Being a pilot study with a relatively small sample size, we were unable to isolate the effects of specific medications or seizure types on the presence of sleep apnea.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Malow/Principal Investigator | Vanderbilt University | 615-322-0283 | beth.malow@vanderbilt.edu |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001049 | Apnea |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Placebo-CPAP | Device | Placebo-CPAP |
|
The data presented below represent the number of participants who required only one night of baseline sleep study prior to randomization |
| prior to randomization |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Continuous Positive Airway Pressure |
Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Continuous Positive Airway Pressure |
Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep. |
|
|
|
| Secondary | 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 | Posted | Number | participants | 10 weeks |
|
|
|
| Secondary | 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 | These are participants that were enrolled and assessed to determine if one night of baseline sleep study was sufficient to detect sleep apnea. This occurred prior to randomization. Five of the assessed participants were not randomized. | Posted | Number | Participants | prior to randomization |
|
|
|
| 0 |
| 13 |
| 2 |
| 13 |
| EG001 | Continuous Positive Airway Pressure | Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep. | 0 | 22 | 5 | 22 |
|
| skin irritation | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment | Skin irritation at site of CPAP mask |
|
| nasal congestion | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment | nasal congestion for CPAP use |
|
| GI discomfort | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment | Gastrointestinal discomfort after use of CPAP |
|
| anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment | anxious using CPAP |
|
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| D012120 |
| Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D012138 |
| Respiratory Therapy |