Transcranial Electrostimulation and Obstructive Sleep Apnea Surgery (NCT03735004) | Clinical Trial Compass
CompletedNot Applicable
Transcranial Electrostimulation and Obstructive Sleep Apnea Surgery
United States45 participantsStarted 2017-07-18
Plain-language 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. 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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.
. Patients with the documented or suspected organic brain or psychiatric disease, in particular with the history of hallucinations and delusions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Opioid Requirements During First Postoperative TES Session
Timeframe: Recorded during a 20 min TES session administered for first moderate-to-severe postoperative pain in the recovery room
2
Pain Scores During First Postoperative TES Session
Timeframe: Recorded during a 20 min TES session administered for first moderate-to-severe postoperative pain in the recovery room
3
Postoperative Opioid Consumption During Recovery Room Stay
Timeframe: During the recovery room stay until "floor ready" (on average 2.5 hours)
4
Postoperative Pain Scores During Recovery Room Stay
Timeframe: During the recovery room stay until "floor ready" (on average 2.5 hours)
. Patients with history of significant eye disease, or head or eye injury, which led to alteration of the cranial anatomy or metallic intracranial implants.