RECRUITING

Transcranial Electrostimulation and Obstructive Sleep Apnea Surgery

Conditions

Transcranial Electrical Stimulation electrical stimulation electric anesthesia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effects of Transcranial Electrostimulation (TES) on Postoperative Pain and Functional Patient Outcomes After Surgery for Obstructive Sleep Apnea Syndrome

Quick Facts

Study Start:2017-07-18

Study Completion:2024-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03735004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	1. Patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to Sevoflurane, an inhaled anesthetic agent. 2. Pregnant patients. 3. Patients who are unable to understand the questionnaires or the visual analogue scale (VAS) pain scores, or to keep home diaries. 4. Patients with clinically-significant psychological disorders, psychiatric illness or treatment. 5. Alcohol and drug-abusing patients. 6. Patients with the history of seizures. 7. Patients with the documented or suspected organic brain or psychiatric disease, in particular with the history of hallucinations and delusions. 8. Patients with history of significant eye disease, or head or eye injury, which led to alteration of the cranial anatomy or metallic intracranial implants. 9. Patients with the history of significant surgery of the head and/or eye. 10. Patients with skin lesions and/or defects over the areas where TES electrodes will be applied. 11. Patients with implanted medical devices, including cardiac pacemakers. 12. Patients who participate in other research protocols that may interfere with the study outcomes and objectives. 13. Other patients that may be excluded by the investigator, based on medical history and physical examination.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

1. Patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to Sevoflurane, an inhaled anesthetic agent.
2. Pregnant patients.
3. Patients who are unable to understand the questionnaires or the visual analogue scale (VAS) pain scores, or to keep home diaries.
4. Patients with clinically-significant psychological disorders, psychiatric illness or treatment.
5. Alcohol and drug-abusing patients.
6. Patients with the history of seizures.
7. Patients with the documented or suspected organic brain or psychiatric disease, in particular with the history of hallucinations and delusions.
8. Patients with history of significant eye disease, or head or eye injury, which led to alteration of the cranial anatomy or metallic intracranial implants.
9. Patients with the history of significant surgery of the head and/or eye.
10. Patients with skin lesions and/or defects over the areas where TES electrodes will be applied.
11. Patients with implanted medical devices, including cardiac pacemakers.
12. Patients who participate in other research protocols that may interfere with the study outcomes and objectives.
13. Other patients that may be excluded by the investigator, based on medical history and physical examination.

Contacts and Locations

Principal Investigator

Vladimir Nekhendzy, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford Univeristy Medical Center

Stanford, California, 94305

United States

Collaborators and Investigators

Sponsor: Stanford University

Vladimir Nekhendzy, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-07-18

Study Completion Date2024-08-31

Study Record Updates

Study Start Date2017-07-18

Study Completion Date2024-08-31

Terms related to this study

Keywords Provided by Researchers

electrical stimulation
electric anesthesia

Additional Relevant MeSH Terms

Transcranial Electrical Stimulation