Association of Sleep Quality With Pathologic Staging, Acupuncture Treatment in Patients With Chronic Atrophic Gastritis: a Cross-sectional Study

March 29, 2025 updated by: Yi Liang

In order to inform clinical treatment decisions and maximize treatment outcomes, this observational study set out to examine the relationship between pathological severity and sleep quality in patients with CAG. The idea that "if the stomach is not in harmony, you will be restless" is supported by this evidence from traditional Chinese medicine. Assessing patients' knowledge and acceptance of acupuncture therapy, determining the current general trend in CAG treatment, and assessing the initial effectiveness of acupuncture therapy in treating CAG with sleep disturbances. It is envisaged that the aforementioned investigations will aid in further refining the clinical research strategy of acupuncture and moxibustion with CAG with sleep disorders, enhance the effectiveness of treatment, and offer a more cost-effective and practical choice for treating CAG with sleep disorders.

The primary research issue is: can the traditional Chinese medical notion of "restlessness due to disharmony of the stomach" be validated in order to ascertain whether there is a correlation between pathological severity and sleep quality in patients with chronic atrophic gastritis? The pathological conditions of CAG patients were gathered based on the most recent gastroscopy report within a year, and the patients' sleep quality scores from the previous month were gathered via a questionnaire.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, cross-sectional study

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hangzhou, China
        • the Ethics Board of Te Thnird Affiliated Hospital of Zhejjiang Chinese Medicinal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This multicenter clinical investigation is coordinated by Zhejiang Chinese Medical University (ZCMU) with participant enrollment conducted at the Third Affiliated Hospital of ZCMU. To establish a conclusive diagnosis for each participant, the researchers conduct an upper gastrointestinal endoscopy screening and assess serum pepsinogen levels during recruitment, subsequently identifying and continuously enrolling all eligible patients at the aforementioned hospitals until the requisite sample size is attained.

Description

Inclusion Criteria:

  1. Have been diagnosed with chronic atrophic gastritis;
  2. Be between the ages of 18 and 75, with no restrictions on gender;
  3. Read the informed consent form, sign it, and consent to participate in this study.

Exclusion Criteria:

  1. autoimmune gastritis (chronic atrophic gastritis type A);
  2. patients with gastroesophageal reflux disease (GERD) as determined by endoscopy or other examinations, or patients with high-grade intraepithelial neoplasia pathologically as determined by upper gastrointestinal endoscopy and gastric mucosal biopsy;
  3. patients with confirmed or unexcluded malignant tumors, particularly esophageal and gastric cancer;patients with other upper gastrointestinal pathologies, such as Barrett's esophagus or peptic ulcer;
  4. additional physical, mental, psychological, or pathological conditions that may impact sleep scores, such as the use of medications for insomnia, night shifts, jet lag, major events, severe neurosis, menopausal syndrome, uncontrolled hyperthyroidism, severe diabetic peripheral neuropathy, within a month after surgical trauma, etc.
  5. People who use medicines that can make you sleepy at the same time and stop using them for less than a month;
  6. People who can't finish the questionnaire because they're unconscious, can't talk regularly, or have other issues; people who don't have enough information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation coefficient between various pathological stages of Operative Link on Gastritis Assessment (OLGA) and Operative Link on Gastric Intestinal Metaplasia (OLGIM) and sleep quality in patients with chronic atrophic gastritis (CAG) is the main o
Time Frame: Gastroscopy and pathology reports within one year and sleep quality assessment within one week of participant enrollment
General condition (age, gender, height, weight, etc.), occupation, personal and family history, Helicobacter pylori infection history, acupuncture treatment, Pittsburgh sleep quality index, serum pepsinogen index, gastroscopy results, and clinical data (OLGA and OLGIM for gastric mucosal histopathology) were among the information that the researchers gathered. The association between the histological stages of OLGA and OLGIM in stomach mucosal histopathology and the sleep quality index in CAG patients was then examined by the researchers.
Gastroscopy and pathology reports within one year and sleep quality assessment within one week of participant enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acupuncture treatment response and sleep quality relationships, as well as other pertinent risk factors, were secondary outcomes
Time Frame: Patient's treatment to date after diagnosis of chronic atrophic gastritis, and whether participant has received acupuncture in the last 3 months
The clinical research program of acupuncture and moxibustion with CAG with sleep disturbances was further adjusted to evaluate the relationship between acupuncture treatment and sleep quality in CAG patients. The researchers looked into how CAG patients were treated overall, including whether they had previously undergone acupuncture treatment, their preferences for different acupuncture treatments, and their willingness and acceptance of acupuncture treatment. Additionally, the quality of the CAG patients' sleep throughout the previous month was examined.
Patient's treatment to date after diagnosis of chronic atrophic gastritis, and whether participant has received acupuncture in the last 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yi Liang

Collaborators

Zhejiang Provincial Department of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2025

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

March 29, 2025

First Submitted That Met QC Criteria

March 29, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

March 29, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20250303032132260

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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