## Protocol Section
### Identification Module
**NCT ID:** NCT06421051

**Acronym:** Vnstep

**Brief Title:** Transauricular Vagus Nerve Stimulation Improves Postoperative Sleep Disorders in Elderly Patients.

**Official Title:** Transauricular Vagus Nerve Stimulation (taVNS) Improves Postoperative Sleep Disorders in Elderly Patients:a Randomized Controlled Study.

#### Organization Study ID Info
**ID:** HX-B-2024016
#### Organization
**Class:** OTHER
**Full Name:** Beijing Tiantan Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Tiantan Hospital

#### Responsible Party

**Investigator Affiliation:** Beijing Tiantan Hospital

**Investigator Full Name:** Ruquan Han

**Investigator Title:** professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Vagus Nerve Stimulation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 164

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: Transauricular Vagal Nerve Stimulation

**Label:** Transauricular Vagal Nerve Stimulation

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Device: Transauricular Vagal Nerve Stimulation

**Label:** Transauricular Vagal Nerve sham Stimulation

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Transauricular Vagal Nerve Stimulation

- Transauricular Vagal Nerve sham Stimulation

**Description:** Transauricular vagal nerve stimulation

**Name:** Transauricular Vagal Nerve Stimulation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Incidence of sleep disorders within 5 days after surgery.

**Time Frame:** Day 1 to day 5 after surgery.

#### Secondary Outcomes

**Description:** The investigators collected patient-related information on postoperative days 1, 3, and 5 by using the Pittsburgh Sleep Quality Index (total score ranges from 0 to 21, with higher scores indicating poorer sleep quality) and a sleep monitoring bracelet, and analyzed the subsequent data.

**Measure:** Sleep quality after surgery.

**Time Frame:** Day 1,3,5 after surgery.

**Description:** The investigators collected information from the patients on the 1st and 2nd postoperative days by Visual Analogue Scale and analyzed the data subsequently. The scale is based on a 10-cm horizontal line drawn on a piece of paper, with 0 cm at one end of the line indicating "no pain at all" and 10 cm at the other end indicating "extreme pain"; the level of pain increases from 0 to 10 cm, with higher scores indicating more intense pain. The higher the score, the more severe the pain.

**Measure:** Postoperative pain score

**Time Frame:** Day1 and 2 after surgery.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients undergoing non-craniocerebral surgery under elective general anesthesia
* Age ≥65 years old
* American society of Aneshesiologists Grade I to III
* Sign informed consent

Exclusion Criteria:

* Patients who are expected to retain tracheal intubation after surgery
* Disturbance of consciousness, mental disorder, inability to cooperate
* Expected survival \< 3 months
* The estimated operation time is \< 2 hours
* The expected postoperative hospital stay is \< 5 days

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ruquan.han@ccmu.edu.cn

**Name:** Ruquan Han, MD

**Phone:** 8610-59976660

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M22242

- Name: Parasomnias

- Relevance: HIGH

- As Found: Sleep Disorders

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: HIGH

- As Found: Sleep Disorders

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000020447

- Term: Parasomnias

### Misc Info Module

- Version Holder: 2024-05-31
