Sleep Apnea SyndromesSASERNCT03200769
Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy
A study testing CPAP active in people with Sleep Apnea Syndromes and Epilepsies, Partial, run by University Hospital, Lille at 1 site in France.
Trial summary
Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy. The primary goal is to evaluate the efficacity after 3 months of obstructive sleep apnea syndrome treatment by CPAP on the epilepsy seizures frequency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes, Epilepsies, Partial
- What is being tested?
- CPAP active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2014to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age ≥ 18.
- Patient suffering of pharmacoresistant epilepsy.
- Frequency of epilepsy crisis : minimum 4 per month.
- Antiepileptic drug on a stable dose for at least 2 months.
- SA-SDQ score ≥ 25.
- Written informed consent obtained.
- Patient affiliated with a social security regimen.
Who cannot join
- Pregnant females (female subjects who are lactating are not excluded).
- Anterior CPAP treatment.
- Central apnea >20% during the initial polysomnography.
- Mental retardation or severe cognitive impairment.
- Presence of pseudo-crisis.
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU de Lille - Rue Emile LAINE - Hopitâl Roger Salengro Rez de Chaussée - Neurophysiologie Clinique
Lille, 59037
About this study
Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy. The primary goal is to evaluate the efficacity after 3 months of obstructive sleep apnea syndrome treatment by CPAP on the epilepsy seizures frequency.
- Conditions
- Sleep Apnea Syndromes, Epilepsies, Partial
- Being tested
- CPAP active, CPAP placebo
- Keywords
- CPAP, Sleep Apnea Syndrome, Pharmacoresistant Epilepsy, Apnea Hypopnea-Index
- Medical subject headings
- Sleep Apnea Syndromes, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP activeDevice
CPAP PR1 Philips Respironics with a pression between 4 and 14 mm Hg
CPAP placeboDevice
CPAP PR1 Philips Respironics with a constant pression of 4 mm Hg.
| Study group | Role | What they receive |
|---|---|---|
| Group I | No intervention | AHI/h < 15 |
| Group IIa | Experimental | 15 < AHI/h < 30. Randomization group. Intervention : CPAP active Receives: Device: CPAP active |
| Group IIb | Experimental | 15 < AHI/h < 30. Randomization group. Intervention : CPAP placebo during the first 3 months. After this period, the patient will have the possibility to continue with an active CPAP. Receives: Device: CPAP placebo |
| Group III | Active comparator | AHI/h > 30. Intervention : CPAP active Receives: Device: CPAP active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients from group IIa and IIb with decreased seizure frequency
Decreased > 50% after CPAP treatment
Measured: At 3 months
Secondary outcomes (10)
Number of patients from group IIa and IIb with decreased seizure frequency
Decreased > 50% after CPAP treatment
Measured: At 6 months ; At 12 months
Number of patients from group III with decreased seizure frequency
Decreased > 50% after CPAP treatment
Measured: At 3 months ; At 6 months ; At 12 months
Impact of AHI on the number of night seizures
Does the AHI has an impact on the number of night seizure?
Measured: At 12 months
Impact of the localisation and the type of epilepsy based on patient medical history exam (video-electroencephalogram) on the SAS risk
Does the AHI is impacted by the localisation and the type of epilepsy?
Measured: At 12 months
Number of seizures based on the seizures diary
Impact of SAS treatment on the pharmacoresistance
Measured: At 12 months
Number of patients who became drug-susceptible based on the seizures diary
Impact of SAS treatment on the pharmacoresistance
Measured: At 3 months ; At 6 months ; At 12 months
Quality of life questionnaire (QOLIE 31)
Impact of SAS treatment on the quality of life
Measured: At 3 months ; At 6 months ; At 12 months
Anxiety and depression questionnaire (BECK)
Impact of SAS treatment on anxiety and depression
Measured: At 3 months ; At 6 months ; At 12 months
Somnolence questionnaire (Epworth)
Impact of SAS treatment on somnolence
Measured: At 3 months ; At 6 months ; At 12 months
Cognitive capacity questionnaire (MOCA)
Impact of SAS treatment on cognitive capacity questionnaire
Measured: At 3 months ; At 6 months ; At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start21 Jul 2014
- Primary completionJul 2021
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe DERAMBURE, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200769
- Sponsor's protocol ID
- 2012_66
- Other IDs
- 2013-A01156-39
- Acronym
- SASER
- Status last verified
- Sep 2022
- First submitted
- 12 Jun 2017
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy
- ClinicalTrials.gov ID
- NCT03200769
- Acronym / sponsor ID
- SASER / 2012_66
- Conditions
- Sleep Apnea Syndromes, Epilepsies, Partial
- Keywords
- CPAP, Sleep Apnea Syndrome, Pharmacoresistant Epilepsy, Apnea Hypopnea-Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 21 Jul 2014 (actual)
- Primary completion
- Jul 2021 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy. The primary goal is to evaluate the efficacity after 3 months of obstructive sleep apnea syndrome treatment by CPAP on the epilepsy seizures frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | No intervention | –AHI/h < 15 |
| Group IIa | Experimental | Device: CPAP active15 < AHI/h < 30. Randomization group. Intervention : CPAP active |
| Group IIb | Experimental | Device: CPAP placebo15 < AHI/h < 30. Randomization group. Intervention : CPAP placebo during the first 3 months. After this period, the patient will have the possibility to continue with an active CPAP. |
| Group III | Active comparator | Device: CPAP activeAHI/h > 30. Intervention : CPAP active |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female age ≥ 18.
- Patient suffering of pharmacoresistant epilepsy.
- Frequency of epilepsy crisis : minimum 4 per month.
- Antiepileptic drug on a stable dose for at least 2 months.
- SA-SDQ score ≥ 25.
Key exclusion criteria (5 listed)
- Pregnant females (female subjects who are lactating are not excluded).
- Anterior CPAP treatment.
- Central apnea >20% during the initial polysomnography.
- Mental retardation or severe cognitive impairment.
- Presence of pseudo-crisis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP activeCPAP PR1 Philips Respironics with a pression between 4 and 14 mm Hg | Device | Group III, Group IIa |
| CPAP placeboCPAP PR1 Philips Respironics with a constant pression of 4 mm Hg. | Device | Group IIb |
Primary outcome
Number of patients from group IIa and IIb with decreased seizure frequency
Time frame: At 3 months
Decreased > 50% after CPAP treatment
10 secondary outcomes
Number of patients from group IIa and IIb with decreased seizure frequency
Time frame: At 6 months ; At 12 months
Number of patients from group III with decreased seizure frequency
Time frame: At 3 months ; At 6 months ; At 12 months
Impact of AHI on the number of night seizures
Time frame: At 12 months
Impact of the localisation and the type of epilepsy based on patient medical history exam (video-electroencephalogram) on the SAS risk
Time frame: At 12 months
Number of seizures based on the seizures diary
Time frame: At 12 months
Number of patients who became drug-susceptible based on the seizures diary
Time frame: At 3 months ; At 6 months ; At 12 months
Quality of life questionnaire (QOLIE 31)
Time frame: At 3 months ; At 6 months ; At 12 months
Anxiety and depression questionnaire (BECK)
Time frame: At 3 months ; At 6 months ; At 12 months
Somnolence questionnaire (Epworth)
Time frame: At 3 months ; At 6 months ; At 12 months
Cognitive capacity questionnaire (MOCA)
Time frame: At 3 months ; At 6 months ; At 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe DERAMBURE, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP active in people with Sleep Apnea Syndromes and Epilepsies, Partial, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients from group IIa and IIb with decreased seizure frequency (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.