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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through the recovery room stay, on average 2.5 hours
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Opioid requirements during first postoperative TES session
Pain scores during first postoperative TES session
Postoperative opioid consumption during recovery room stay
+1 moreSecondary outcome measures
Change from baseline in QoR15 score (Quality of Recovery 15-question score)
Post-discharge postoperative opioid consumption
Postoperative opioid consumption during hospital stay
+3 moreTrial 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
2,393 Previous Clinical Trials
17,341,147 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total size of the population participating in this experiment?
"Affirmative. Per clinicaltrials.gov, this research initiative is attempting to enroll 45 individuals at a single site and was first posted on July 18th 2017 with its most recent update occurring on May 17th 2021."
Answered by AI
Is this research experiment open to people under 35 years of age?
"Patients between the ages of 18 to 70 are eligible for enrollment in this trial. For younger individuals, there are 36 studies available while 188 clinical trials accept patients above 65 years old."
Answered by AI
Are there still opportunities for patient participation in this clinical trial?
"Affirmative. According to clinicaltrials.gov, the trial is currently open for enrolment and was initially listed on July 18th 2017 with most recent alterations done in May 17th 2021. 45 individuals are required from 1 medical center as participants."
Answered by AI
Is it feasible for me to join this clinical experiment?
"In order to partake in this research, prospective patients must have received transcranial electrical stimulation and possess an age between 18 and 70. A total of 45 individuals are sought for the experiment."
Answered by AI
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