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Transcranial Electrostimulation and Obstructive Sleep Apnea Surgery

NCT03735004 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-04-25

No results posted yet for this study

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.

Conditions

  • Transcranial Electrical Stimulation

Interventions

DEVICE

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

Sponsors & Collaborators

Principal Investigators

  • Vladimir Nekhendzy, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-18
Primary Completion
2024-08-31
Completion
2024-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03735004 on ClinicalTrials.gov