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NCT Number: NCT06912178

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

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.

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Key information

Conditions

Chronic Atrophic Gastritis (CAG) Digestive System Diseases Dyssomnias Gastritis Gastritis, Atrophic Gastroenteritis Gastrointestinal Diseases Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stomach Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Ethics Board of Te Thnird Affiliated Hospital of Zhejjiang Chinese Medicinal University

Hangzhou, China

About this study

This is a single-center, cross-sectional study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • autoimmune gastritis (chronic atrophic gastritis type A);
  • 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;
  • 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;
  • 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.
  • People who use medicines that can make you sleepy at the same time and stop using them for less than a month;
  • 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.

Treatment and study plan

Acupuncture

Other

Whether or not a patient has been treated with acupuncture will be one of the exposure factors of interest in the study

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Liang, Doctor

CONTACT

[email protected]

+86 571 86633328

Sponsors and collaborators

Lead sponsor

Yi Liang

Other

Collaborators

  • Zhejiang University of Science and Technology

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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