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Behavioural Intervention

Breathing Interventions for SUDEP Prevention in Epilepsy (BreatheS Trial)

N/A

Recruiting

Led By Nuria L Lecumberri, MD,PhD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (before breathing task), at the time of the breathing task(about 8 minutes after start of baseline)

Awards & highlights

BreatheS Trial Summary

This trial aims to map brain networks that control breathing & find ways to stop seizures from affecting it.

Who is the study for?

This trial is for individuals with intractable focal epilepsy who are admitted to the Epilepsy Monitoring Unit at Memorial Hermann-Texas Medical Center for specific brain monitoring procedures. It's not suitable for pregnant women, prisoners, or those with respiratory, cardiac, or cerebrovascular diseases.Check my eligibility

What is being tested?

The study aims to map out brain networks that control breathing and find ways to stimulate certain brain areas to prevent breathing failure during seizures using tasks and mapping techniques.See study design

What are the potential side effects?

Potential side effects may include discomfort from the breathing tasks or adverse reactions from the brain stimulation, such as headaches or temporary changes in mood or cognition.

BreatheS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Saturation of peripheral oxygen (SpO2) during stimulation as assessed by the pulse oximetry

Change in end tidal carbon dioxide (CO2) during stimulation

Change in percentage of breathing node size as assessed by electroencephalogram (EEG) signal

+3 more

Secondary outcome measures

Quantification of the breathing changes as assessed by the change in breathing depth

Quantification of the breathing changes as assessed by the change in breathing minute ventilation (MV)

Quantification of the breathing changes as assessed by the change in breathing rate

BreatheS Trial Design

1Treatment groups

Experimental Treatment

Group I: Breathing tasks and Brain mapping with stimulationExperimental Treatment2 Interventions

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,860 Total Patients Enrolled

7 Trials studying Epilepsy

393 Patients Enrolled for Epilepsy

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,341 Previous Clinical Trials

649,489 Total Patients Enrolled

78 Trials studying Epilepsy

24,953 Patients Enrolled for Epilepsy

Nuria L Lecumberri, MD,PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Breathing Rescue (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05981755 — N/A

Epilepsy Research Study Groups: Breathing tasks and Brain mapping with stimulation

Epilepsy Clinical Trial 2023: Breathing Rescue Highlights & Side Effects. Trial Name: NCT05981755 — N/A

Breathing Rescue (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05981755 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new participants being recruited for this research project?

"Data on clinicaltrials.gov reveals that this trial has not been actively recruiting since July 31st 2023, and there are currently no plans to re-open recruitment for the study. Fortunately, 30 other trials have remained open with participants still being welcomed in."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Breathing Rescue for SUDEP Prevention

Nuria Lacuey Lecumberri 2023. "Breathing Rescue for SUDEP Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05981755.