Transcranial Electrical StimulationNCT03735004
Transcranial Electrostimulation and Obstructive Sleep Apnea Surgery
A study testing Transcranial electrostimulation (TES) in people with Transcranial Electrical Stimulation, run by Stanford University at 1 site in United States.
Trial summary
Postoperative pain after major surgery for obstructive sleep apnea (OSA), such as palatopharyngoplasty (PPP) and maxillomandibular advancement (MMA) is moderate-to-severe, and may persist for weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transcranial Electrical Stimulation
- What is being tested?
- Transcranial electrostimulation (TES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2017to 9 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to Sevoflurane, an inhaled anesthetic agent.
- Pregnant patients.
- Patients who are unable to understand the questionnaires or the visual analogue scale (VAS) pain scores, or to keep home diaries.
- Patients with clinically-significant psychological disorders, psychiatric illness or treatment.
- Alcohol and drug-abusing patients.
- Patients with the history of seizures.
Show all 13Show fewer
- Patients with the documented or suspected organic brain or psychiatric disease, in particular with the history of hallucinations and delusions.
- Patients with history of significant eye disease, or head or eye injury, which led to alteration of the cranial anatomy or metallic intracranial implants.
- Patients with the history of significant surgery of the head and/or eye.
- Patients with skin lesions and/or defects over the areas where TES electrodes will be applied.
- Patients with implanted medical devices, including cardiac pacemakers.
- Patients who participate in other research protocols that may interfere with the study outcomes and objectives.
- Other patients that may be excluded by the investigator, based on medical history and physical examination.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Univeristy Medical Center
Stanford, California, 94305
About this study
Official title: The Effects of Transcranial Electrostimulation (TES) on Postoperative Pain and Functional Patient Outcomes After Surgery for Obstructive Sleep Apnea Syndrome
Postoperative pain after major surgery for obstructive sleep apnea (OSA), such as palatopharyngoplasty (PPP) and maxillomandibular advancement (MMA) is moderate-to-severe, and may persist for weeks. Control of this pain may be difficult, because OSA patients are very sensitive to traditional opioid pain medications, and their side effects. Poorly controlled pain slows down patients' recovery after surgery, including a return to normal daily activities and work, and may also delay wound healing.
This study will investigate whether pain relief and recovery after surgery may be improved with the application of a weak electrical current to the skin of the patient's head (transcranial electrostimulation, TES). The TES works by blocking pain in the central nervous system through multiple mechanisms, which result in non-pharmacological pain relief, without drug-associated side effects.
Read the detailed description
The incidence and severity of postoperative pain in patients undergoing major airway surgery for OSA, such as palatopharyngoplasty (PPP) and maxillomandibular advancement (MMA) is high, and may persist for days, significantly contributing to patient's morbidity. High doses of intravenous and oral opioids are frequently required to achieve adequate pain relief. Yet, the increased sensitivity of OSA patients to opioid analgesics, and associated high risk of postoperative respiratory depression and upper airway obstruction limit the traditional therapeutic options, frequently making pain control after PPP and MMA surgery suboptimal.
The effect of significant postoperative pain on surgical outcomes is multifold. Poorly controlled post-surgical pain increases patient morbidity, impairs wound healing, and negatively affects patient recovery and functional outcomes, such as ambulation, a resumption of a normal oral intake, a return to normal daily activities, a return to work, and others. Side effects of opioid medications, such as urinary retention, constipation, nausea, vomiting, dizziness, and itching may further adversely affect recovery and cause patient dissatisfaction with the surgical procedure.
The development of the new, effective analgesic modalities, is therefore highly desirable for OSA surgical patients, and particularly those undergoing PPP and MMA surgeries. Transcranial electrostimulation (TES) is a non-invasive brain stimulation technique that employs administration of a weak electrical current (≤ 5 mA) through the electrodes positioned on the skin of the patient's head. TES is a safe procedure, with a low risk of associated, minor side effects It is widely believed that TES with combined direct (DC) and alternating (AC) current (TES DC:AC) triggers the release of endogenous opioids and other central neurotransmitters (e.g. norepinephrine) that interrupt nociceptive processing. The investigator's previous studies have demonstrated that TES DC:AC produces quickly evolving, effective non-pharmacological analgesia, without associated respiratory depression or other opioid-induced side effects. If analgesic effect of TES can be demonstrated in this study, the TES may become an attractive adjunct for postoperative analgesic treatment for OSA patients, allowing for improved quality of analgesia and enhanced recovery.
Moreover, demonstrating TES analgesic effect may facilitate its widespread use as a non-pharmacological analgesic adjunct postoperatively, especially in elderly patients, who have a high incidence of associated OSA and sensitivity to systemic opioids. The incidence of OSA in general surgical population reaches over 20%.
- Conditions
- Transcranial Electrical Stimulation
- Being tested
- Transcranial electrostimulation (TES)
- Keywords
- electrical stimulation, electric anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial electrostimulation (TES)Device
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC) current, or TES with DC only will be administered through the skin electrodes positioned on the patient's head
| Study group | Role | What they receive |
|---|---|---|
| TES 60 Hz DC:AC | Experimental | Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current Receives: Device: Transcranial electrostimulation (TES) |
| TES 100 Hz DC:AC | Active comparator | Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current Receives: Device: Transcranial electrostimulation (TES) |
| TES with DC current | Sham comparator | Transcranial electrostimulation (TES) with direct current (DC) only Receives: Device: Transcranial electrostimulation (TES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Requirements During First Postoperative TES Session
IV morphine milligram equivalents
Measured: Recorded during a 20 min TES session administered for first moderate-to-severe postoperative pain in the recovery room
Pain Scores During First Postoperative TES Session
VAS pain scores (Pain measured using 11-point visual analog scale 0-10, 0 no pain, 10 worst pain imaginable).
Measured: Recorded during a 20 min TES session administered for first moderate-to-severe postoperative pain in the recovery room
Postoperative Opioid Consumption During Recovery Room Stay
IV morphine milligram equivalents
Measured: During the recovery room stay until "floor ready" (on average 2.5 hours)
Postoperative Pain Scores During Recovery Room Stay
VAS pain scores (Pain measured using 11-point visual analog scale 0-10, 0 no pain, 10 worst pain imaginable).
Measured: During the recovery room stay until "floor ready" (on average 2.5 hours)
Secondary outcomes (7)
Postoperative Opioid Consumption During Post-operative Day 0
PO morphine milligram equivalents
Measured: From "floor ready" until midnight of the day after surgery (POD#0, (postoperative day #0).
Post-discharge Postoperative Opioid Consumption
PO morphine milligram equivalents
Measured: From POD#1 through the 1st postoperative week after surgery.
Time to Discharge From the Recovery Room
Measured: Day of surgery (postoperative day #0, POD#0).
Time to Start of Soft Diet
Measured: Day of surgery to starting a soft diet (up to 7 days postoperative)
Time to Return to Daily Activities
Measured: Day of surgery to return to daily activities to postoperative week 4.
Time to Return to Work
Measured: From the day of surgery to return to work to postoperative week 4.
Change From Baseline in QoR15 Score (Quality of Recovery 15-question Score)
Validated multidimensional questionnaire assessing recovery profile. Each scale is scored from 0-10, overall score from 0 to 150. The higher scores indicate better recovery.
Measured: Baseline (before surgery) to postoperative week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start18 Jul 2017
- Primary completion11 Jan 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Transcranial Electrical StimulationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Nekhendzy, Stanford University
- Investigators
- Vladimir Nekhendzy, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735004
- Sponsor's protocol ID
- 29984
- Status last verified
- Aug 2025
- First submitted
- 5 Nov 2018
- Last updated
- 22 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcranial Electrostimulation (TES) on Postoperative Pain and Functional Patient Outcomes After Surgery for Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT03735004
- Acronym / sponsor ID
- 29984
- Conditions
- Transcranial Electrical Stimulation
- Keywords
- electrical stimulation, electric anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Posted 22 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pain after major surgery for obstructive sleep apnea (OSA), such as palatopharyngoplasty (PPP) and maxillomandibular advancement (MMA) is moderate-to-severe, and may persist for weeks. Control of this pain may be difficult, because OSA patients are very sensitive to traditional opioid pain medications, and their side effects. Poorly controlled pain slows down patients' recovery after surgery, including a return to normal daily activities and work, and may also delay wound healing.
This study will investigate whether pain relief and recovery after surgery may be improved with the application of a weak electrical current to the skin of the patient's head (transcranial electrostimulation, TES). The TES works by blocking pain in the central nervous system through multiple mechanisms, which result in non-pharmacological pain relief, without drug-associated side effects.
Detailed description
The incidence and severity of postoperative pain in patients undergoing major airway surgery for OSA, such as palatopharyngoplasty (PPP) and maxillomandibular advancement (MMA) is high, and may persist for days, significantly contributing to patient's morbidity. High doses of intravenous and oral opioids are frequently required to achieve adequate pain relief. Yet, the increased sensitivity of OSA patients to opioid analgesics, and associated high risk of postoperative respiratory depression and upper airway obstruction limit the traditional therapeutic options, frequently making pain control after PPP and MMA surgery suboptimal.
The effect of significant postoperative pain on surgical outcomes is multifold. Poorly controlled post-surgical pain increases patient morbidity, impairs wound healing, and negatively affects patient recovery and functional outcomes, such as ambulation, a resumption of a normal oral intake, a return to normal daily activities, a return to work, and others. Side effects of opioid medications, such as urinary retention, constipation, nausea, vomiting, dizziness, and itching may further adversely affect recovery and cause patient dissatisfaction with the surgical procedure.
The development of the new, effective analgesic modalities, is therefore highly desirable for OSA surgical patients, and particularly those undergoing PPP and MMA surgeries. Transcranial electrostimulation (TES) is a non-invasive brain stimulation technique that employs administration of a weak electrical current (≤ 5 mA) through the electrodes positioned on the skin of the patient's head. TES is a safe procedure, with a low risk of associated, minor side effects It is widely believed that TES with combined direct (DC) and alternating (AC) current (TES DC:AC) triggers the release of endogenous opioids and other central neurotransmitters (e.g. norepinephrine) that interrupt nociceptive processing. The investigator's previous studies have demonstrated that TES DC:AC produces quickly evolving, effective non-pharmacological analgesia, without associated respiratory depression or other opioid-induced side effects. If analgesic effect of TES can be demonstrated in this study, the TES may become an attractive adjunct for postoperative analgesic treatment for OSA patients, allowing for improved quality of analgesia and enhanced recovery.
Moreover, demonstrating TES analgesic effect may facilitate its widespread use as a non-pharmacological analgesic adjunct postoperatively, especially in elderly patients, who have a high incidence of associated OSA and sensitivity to systemic opioids. The incidence of OSA in general surgical population reaches over 20%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TES 60 Hz DC:AC | Experimental | Device: Transcranial electrostimulation (TES)Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current |
| TES 100 Hz DC:AC | Active comparator | Device: Transcranial electrostimulation (TES)Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current |
| TES with DC current | Sham comparator | Device: Transcranial electrostimulation (TES)Transcranial electrostimulation (TES) with direct current (DC) only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to Sevoflurane, an inhaled anesthetic agent.
- Pregnant patients.
- Patients who are unable to understand the questionnaires or the visual analogue scale (VAS) pain scores, or to keep home diaries.
- Patients with clinically-significant psychological disorders, psychiatric illness or treatment.
- Alcohol and drug-abusing patients.
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 |
|---|---|---|
| Transcranial electrostimulation (TES)Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC) current, or TES with DC only will be administered through the skin electrodes positioned on the patient's head | Device | TES 100 Hz DC:AC, TES 60 Hz DC:AC, TES with DC current |
Primary outcome
Opioid Requirements During First Postoperative TES Session
Time frame: Recorded during a 20 min TES session administered for first moderate-to-severe postoperative pain in the recovery room
IV morphine milligram equivalents
Pain Scores During First Postoperative TES Session
Time frame: Recorded during a 20 min TES session administered for first moderate-to-severe postoperative pain in the recovery room
VAS pain scores (Pain measured using 11-point visual analog scale 0-10, 0 no pain, 10 worst pain imaginable).
Postoperative Opioid Consumption During Recovery Room Stay
Time frame: During the recovery room stay until "floor ready" (on average 2.5 hours)
IV morphine milligram equivalents
Postoperative Pain Scores During Recovery Room Stay
Time frame: During the recovery room stay until "floor ready" (on average 2.5 hours)
VAS pain scores (Pain measured using 11-point visual analog scale 0-10, 0 no pain, 10 worst pain imaginable).
7 secondary outcomes
Postoperative Opioid Consumption During Post-operative Day 0
Time frame: From "floor ready" until midnight of the day after surgery (POD#0, (postoperative day #0).
Post-discharge Postoperative Opioid Consumption
Time frame: From POD#1 through the 1st postoperative week after surgery.
Time to Discharge From the Recovery Room
Time frame: Day of surgery (postoperative day #0, POD#0).
Time to Start of Soft Diet
Time frame: Day of surgery to starting a soft diet (up to 7 days postoperative)
Time to Return to Daily Activities
Time frame: Day of surgery to return to daily activities to postoperative week 4.
Time to Return to Work
Time frame: From the day of surgery to return to work to postoperative week 4.
Change From Baseline in QoR15 Score (Quality of Recovery 15-question Score)
Time frame: Baseline (before surgery) to postoperative week 4.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Vladimir Nekhendzy, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial electrostimulation (TES) in people with Transcranial Electrical Stimulation, run by Stanford University at 1 site in United States.
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 0 inclusion and 13 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 22 Jun 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Opioid Requirements During First Postoperative TES Session (time frame: Recorded during a 20 min TES session administered for first moderate-to-severe postoperative pain in the recovery room). The study lists 4 primary outcomes in all. 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 22 Jun 2026.