Transcranial Electrostimulation and Obstructive Sleep Apnea Surgery

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT03735004
Status
Recruiting
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Conditions

  • Transcranial Electrical Stimulation

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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.

Key Dates

Start date
Jul 18, 2017
Status verified
Apr 2023
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TES 60 Hz DC:AC
    Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
  • Active Comparator: TES 100 Hz DC:AC
    Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
  • Sham Comparator: TES with DC current
    Transcranial electrostimulation (TES) with direct current (DC) only

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Univeristy Medical CenterStanfordCalifornia94305
Vladimir Nekhendzy, MD
[email protected]
650-498-4055

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By research site
Stanford Univeristy Medical Center· Stanford, CA

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