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Not yet recruitingNCT06912178Updated Apr 4, 2025

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

An observational study in Chronic Atrophic Gastritis (CAG), sponsored by Yi Liang. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Yi Liang · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 25 studies in Gastritis, Atrophic with a site in China — 14 open to participants now, 15 under way, none of them phase 3. Gastritis, Atrophic · China.

Planned enrollment
13th of 16
120 · median 358
Started
2025
with 4 others
Observational
16 of 25
11 open now
Primary completion
2026-03
later than 7 of 14 live
Registered
19th of 25
by date
Lead sponsor
3 of 25
Yi Liang

Among the 25 studies in Gastritis, Atrophic with a site in China, this one is the 13th largest by planned enrollment of the 16 observational ones that give a count, is one of 5 that started in 2025, is one of 16 observational ones, reaches primary completion later than 7 of the 14 other live ones, and was the 19th registered.

Gastritis, Atrophic

75 studies on the registry are indexed under Gastritis, Atrophic; 37 are open to participants now.

Browse Gastritis, Atrophic studies →

Open to participants now

14 of the 25 studies in Gastritis, Atrophic with a site in China are open now. Recruiting first, the newest first:

8 more — sign in →

All 14 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 24 Gastritis, Atrophic studies recruiting now, 13 (54%) set no upper age limit and 5 (21%) stop at 75 or younger; none take children under 18; 10 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

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.

Read the detailed description

This is a single-center, cross-sectional study

03

Conditions studied

  • Chronic Atrophic Gastritis (CAG)

Keywords

  • chronic atrophic gastritis; sleep quality; OLGA; OLGIM; pathologic; acupuncture; cross-sectional
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form, sign it, and consent to participate in this study.

Exclusion criteria

Exclusion Criteria:

  1. 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 ;
  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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherAcupuncture

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

06

What researchers measure

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

    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.

    Time frame: Gastroscopy and pathology reports within one year and sleep quality assessment within one week of participant enrollment

Secondary outcomes

  1. Acupuncture treatment response and sleep quality relationships, as well as other pertinent risk factors, were secondary outcomes

    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.

    Time frame: Patient's treatment to date after diagnosis of chronic atrophic gastritis, and whether participant has received acupuncture in the last 3 months

07

Study locations

1 site
  • the Ethics Board of Te Thnird Affiliated Hospital of Zhejjiang Chinese Medicinal University
    Hangzhou, China
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2025; primary completion for Mar 2026, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2025
First posted
Apr 4, 2025
StartEst.
Mar 30, 2025
Primary completionEst.
Mar 30, 2026
CompletionEst.
Mar 30, 2026
Last update
Apr 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06912178
Lead sponsor
Yi Liang
Collaborators
Zhejiang Provincial Department of Science and Technology
Responsible party
Yi Liang (Research Fellow, The Third Affiliated hospital of Zhejiang Chinese Medical University) — Sponsor-investigator
First posted
Apr 4, 2025
Start date
Mar 30, 2025 (estimated)
Primary completion
Mar 30, 2026 (estimated)
Completion
Mar 30, 2026 (estimated)
Last update
Apr 4, 2025

Study contacts

Yi Liang, Doctor
Contact
liangyiwww@126.com
+86 571 86633328

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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