Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT03735004

Transcranial Electrostimulation and Obstructive Sleep Apnea Surgery

Led by Stanford University · Updated on 2023-04-25

45

Participants Needed

1

Research Sites

371 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Transcranial Electrostimulation and Obstructive Sleep Apnea Surgery

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with moderate-to-severe obstructive sleep apnea undergoing palatopharyngoplasty (PPP) or maxillomandibular advancement (MMA) surgeries
  • American Society of Anesthesiology (ASA) physical status II-III
  • Ability to understand informed consent and study instructions
Not Eligible

You will not qualify if you...

  • Known or suspected genetic susceptibility to malignant hyperthermia or sensitivity to Sevoflurane
  • Pregnancy
  • Inability to understand questionnaires, visual analogue scale (VAS) pain scores, or keep home diaries
  • Clinically significant psychological disorders or psychiatric illness or treatment
  • Alcohol or drug abuse
  • History of seizures
  • Documented or suspected organic brain or psychiatric disease, especially hallucinations or delusions
  • History of significant eye disease or head/eye injury altering cranial anatomy or with metallic intracranial implants
  • History of significant surgery of the head and/or eye
  • Skin lesions or defects over areas where TES electrodes will be applied
  • Implanted medical devices, including cardiac pacemakers
  • Participation in other research protocols that might interfere with the study
  • Other exclusions determined by the investigator based on medical history and physical examination

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Stanford Univeristy Medical Center

Stanford, California, United States, 94305

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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