Transauricular Vagus Nerve Stimulation Improves Postoperative Sleep Disorders in Elderly Patients.

Study acronym: Vnstep
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial status changed: Unknown → Completed Show 5 more changesShow less
    • Primary completion date changed from estimate of Dec 31, 2025 to Jan 31, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Changed Registry marked status Unknown; last known: Recruiting
  3. Start date: May 21, 2024 to Jun 20, 2024
    • Trial status: Recruiting to Unknown
    v6
  4. Site contact updatedv5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 30, 2024 to May 21, 2024
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: May 10, 2024 to Jun 30, 2024v3
  2. Secondary endpoints: details revised at 2 of 2 entriesv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Postoperative sleep disorder is one of the common complications after general anesthesia. Compared to patients of various ages, elderly patients have a much higher incidence of postoperative sleep disturbance. Postoperative sleep disorders can have many adverse effects, including cognitive impairment, altered pain perception, and emotional disorders, which are not conducive to the long-term prognosis of elderly patients. Enhancing postoperative sleep quality in older patients has become a significant public health concern in the current day due to its direct relationship to both maximizing surgical outcomes and enhancing physical health. This study intends to conduct a prospective, randomized controlled, triple-blind clinical trial on use of transauricular vagal nerve stimulation to improve sleep disorders in elderly patients after general anesthesia surgery, aiming to investigate the efficacy of transauricular vagal nerve stimulation in postoperative sleep disorders in elderly patients.
Trial Details
NCT Number NCT06421051
Lead Sponsor Beijing Tiantan Hospital
Conditions
(from sponsor)		 Vagus Nerve Stimulation
Enrollment 164 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov