Auricular Vagus Nerve Stimulation for Anxiety and Sleep Quality in Patients With Generalized Anxiety Disorder
NCT07930871, Not applicable, Not yet recruiting, Birjand University of Medical Sciences
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Auricular Vagus Nerve Stimulation for Anxiety and Sleep Quality in Patients With Generalized Anxiety Disorder | ClinicalTrials.gov |
| NCT number | NCT07930871 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Birjand University of Medical Sciences | ClinicalTrials.gov |
| Conditions | Generalized Anxiety Disorder (GAD) | ClinicalTrials.gov |
| Interventions | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Sham Transcutaneous Auricular Vagus Nerve Stimulation (sham-taVNS) | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Anxiety Severity Measured by the Hamilton Anxiety Rating Scale (HAM-A) | Baseline to Week 8 | Anxiety severity will be assessed using the Hamilton Anxiety Rating Scale (HAM-A), a 14-item clinician-administered scale designed to evaluate the severity of anxiety symptoms. Each item is scored from 0 (not present) to 4 (very severe), yielding a total score ranging from 0 to 56, with higher scores indicating greater anxiety severity. The change in total HAM-A score from baseline to Week 8 will be calculated and compared between the active taVNS and sham stimulation groups. A greater reduction in score indicates a greater improvement in anxiety severity. | ClinicalTrials.gov |
| Secondary | Change in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI) | Baseline to Week 8 | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-reported questionnaire consisting of 19 items that evaluate sleep quality and disturbances over the previous month. The questionnaire generates seven component scores, which are summed to produce a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. The change in the global PSQI score from baseline to Week 8 will be calculated and compared between the active taVNS and sham stimulation groups. A greater reduction in score indicates an improvement in sleep quality. | ClinicalTrials.gov |
| Secondary | Incidence of Adverse Events During the Intervention Period | Baseline through Week 8 | The safety and tolerability of transcutaneous auricular vagus nerve stimulation (taVNS) will be evaluated by monitoring adverse events throughout the intervention period. The number and proportion of participants experiencing at least one adverse event will be recorded in each study group. All reported adverse events will be documented, including their type, severity, duration, and potential relationship to the assigned stimulation intervention. | ClinicalTrials.gov |
| Secondary | Adherence to the Assigned Stimulation Protocol | 4 weeks | Adherence to the assigned stimulation protocol will be assessed based on the proportion of prescribed stimulation sessions successfully completed by each participant during the 4-week intervention period. The number of completed sessions will be recorded and compared with the total number of prescribed sessions. Adherence will be expressed as a percentage, calculated as the number of completed sessions divided by the total number of prescribed sessions, multiplied by 100. Higher percentages indicate better adherence to the intervention protocol. | ClinicalTrials.gov |
| Secondary | Success of participant blinding to treatment allocation in the active and sham stimulation groups | at week 4 (end of intervention) | The success of participant blinding will be evaluated at the end of the intervention period. Participants will be asked to indicate whether they believe they received active taVNS or sham stimulation. The proportion of participants in each group who correctly and incorrectly identify their assigned intervention will be calculated to assess the effectiveness of participant blinding. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
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Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.