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Transcranial Electrical Stimulation for Obstructive Sleep Apnea
N/A
Recruiting
Led By Vladimir Nekhendzy, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients will be American Society of Anesthesiology (ASA) physical status II-III
Patients with moderate-to-severe OSA, presenting for PPP and MMA surgeries
Must not have
Patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to Sevoflurane, an inhaled anesthetic agent
Patients with the history of seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through the recovery room stay, on average 2.5 hours
Summary
This trial will test whether transcranial electrostimulation can help with postoperative pain after surgery for obstructive sleep apnea.
Who is the study for?
This trial is for patients with moderate-to-severe obstructive sleep apnea who are undergoing specific surgeries (PPP and MMA). Participants must be in stable physical condition (ASA II-III) and able to understand the study. Excluded are those with skin issues where electrodes would go, certain anesthetic allergies, pregnancy, comprehension difficulties, substance abuse problems, seizure history or significant psychological disorders.
What is being tested?
The study tests if transcranial electrostimulation (TES), which applies a weak electrical current to the head's skin, can improve pain relief and recovery after surgery for sleep apnea without drug-related side effects. It aims to see if TES can offer non-pharmacological pain control by blocking central nervous system pain.
What are the potential side effects?
Since TES is non-pharmacological—meaning it doesn't use drugs—it avoids traditional medication side effects. However, potential risks may include discomfort at the electrode sites or unforeseen reactions related to the electrical stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My health is fair to severe but not life-threatening.
Select...
I have moderate-to-severe sleep apnea and am getting surgery for it.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic or sensitive to certain anesthesia or have a genetic risk for reaction.
Select...
I have a history of seizures.
Select...
I have had major surgery on my head or eye.
Select...
I have a history of serious mental health issues, including hallucinations or delusions.
Select...
I have skin issues where the TES electrodes will be placed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through the recovery room stay, on average 2.5 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through the recovery room stay, on average 2.5 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Opioid requirements during first postoperative TES session
Pain scores during first postoperative TES session
Postoperative opioid consumption during recovery room stay
+1 moreSecondary study objectives
Change from baseline in QoR15 score (Quality of Recovery 15-question score)
Post-discharge postoperative opioid consumption
Postoperative opioid consumption during hospital stay
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: TES 60 Hz DC:ACExperimental Treatment1 Intervention
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
Group II: TES 100 Hz DC:ACActive Control1 Intervention
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
Group III: TES with DC currentPlacebo Group1 Intervention
Transcranial electrostimulation (TES) with direct current (DC) only
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,472 Previous Clinical Trials
17,501,773 Total Patients Enrolled
Vladimir Nekhendzy, MDPrincipal Investigator - Stanford University
Stanford Hospital, Stanford Hospital and Clinic
First Leningrad I P Pavlov Medical Inst (Medical School)
University Ca Sf School Of Medicine (Residency)
3 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic or sensitive to certain anesthesia or have a genetic risk for reaction.You have a serious mental health condition or are being treated for a psychiatric illness.I have a history of seizures.I have had major surgery on my head or eye.My health is fair to severe but not life-threatening.You have a history of alcohol or drug abuse.You have a history of serious eye disease, head injury, or have metal implants in your head.I have moderate-to-severe sleep apnea and am getting surgery for it.You have a medical device implanted in your body, like a pacemaker.I have a history of serious mental health issues, including hallucinations or delusions.I have skin issues where the TES electrodes will be placed.
Research Study Groups:
This trial has the following groups:- Group 1: TES 60 Hz DC:AC
- Group 2: TES with DC current
- Group 3: TES 100 Hz DC:AC
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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