Biologics, Heart Rate Variability, Inflammatory Bowel Disease, Prediction, Sleep Quality
Conditions
Brief summary
This is a prospective, multicenter, observational cohort study, which plans to enroll patients with active IBD who are scheduled to initiate IFX or VDZ treatment between October 2025 and October 2027 at Xijing Hospital, Tang-du Hospital, and Air Force 986 Hospital. All patients will undergo HRV monitoring at baseline, Week 2, Week 6, and Week 14. The HRV monitoring results will be blinded to both physicians and patients. Based on the efficacy assessment at Week 14, patients will be divided into response and non-response groups for comparison, to analyze the strength of association between baseline HRV parameters and the achievement of clinical response. The study plans to enroll 100 IBD patients, with 50 in the IFX treatment group and 50 in the VDZ treatment group.
Interventions
None listed
Sponsors
Xijing Hospital
Tang-Du Hospital
Air Force 986 Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with UC according to the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023 · Xi'an) or diagnosed with CD according to the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023 · Guangzhou) at least 3 months before enrollment; * Initiation of IFX or VDZ treatment for the first time based on actual clinical needs; * Concomitant use of stable doses of 5-ASA or immunosuppressants is permitted; * Able and willing to wear an HRV monitoring device and sign an informed consent form.
Exclusion criteria
* Patients receiving combination therapy with two or more biological agents; * History of IBD-related surgery within the past 4 weeks or planned surgery during the study period; * Current severe intestinal infection (e.g., uncontrolled Clostridium difficile or cytomegalovirus infection); * Diagnosed extensive small bowel resection or short bowel syndrome; * Uncontrolled psychiatric disorders (e.g., severe anxiety or depression) or use of anti-anxiety/depressant medications that may affect autonomic nervous function; * Use of medications affecting heart rate or autonomic nervous function without the ability to maintain a stable dose during the trial (e.g., beta-blockers, calcium channel blockers, etc.); * Coexisting conditions related to autonomic dysfunction (e.g., hyperthyroidism, thyroiditis, hypertension, various types of conduction blocks, arrhythmias, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity | At baseline, Week 2, Week 6, and Week 14. | The SCCAI score was used to assess clinical disease activity in patients with ulcerative colitis (UC). Clinical response was defined as a reduction in the SCCAI score of ≥3 points from baseline; clinical remission was defined as an SCCAI score ≤2 points. The HBI score was used to assess clinical disease activity in patients with Crohn's disease (CD). Clinical response was defined as a reduction in the HBI score of ≥3 points from baseline; clinical remission was defined as an HBI score ≤4 points. |
| Heart Rate Variability | At baseline, Week 2, Week 6, and Week 14. | A patch-type dynamic electrocardiogram recorder is used to detect HRV. This product is suitable for collecting, monitoring, and storing three-lead dynamic electrocardiogram signals in adults and can be worn continuously. HRV parameters are obtained through continuous 72-hour dynamic ECG data acquisition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Monitoring | During 14 weeks of treatment. | Smart wearable sleep tracking devices (Huawei Band 10) are used for complementary sleep monitoring. Key parameters to be measured include total sleep time, wake after sleep onset and sleep architecture. |
| Pittsburgh Sleep Quality Index (PSQI) | At baseline, Week 6, and Week 14. | PSQI is used to evaluate the sleep quality of the subjects in the last 1 month. There are 7 dimensions and 9 entries with a total score between 0 and 21, where a score higher than 5 indicates a sleep quality problem, 0 to 5 indicates good sleep quality, 6 to 10 indicates moderate sleep quality, 11 to 15 indicates poor sleep quality, and 16 to 21 indicates very poor sleep quality. |
| Insomnia Severity Index (ISI) | At baseline, Week 6, and Week 14. | The ISI is used to evaluate the severity of insomnia in patients, primarily evaluating sleep problems over the past two weeks and their impact on quality of life. The scale consists of seven items, each rated on a 5-point scale (0 = none, 4 = very severe), with a total score ranging from 0 to 28. Higher scores indicate more severe insomnia, where 0-7 points indicate no clinically significant insomnia, 8-14 points indicate subthreshold insomnia, 15-21 points indicate moderate clinical insomnia, and 22-28 points indicate severe clinical insomnia. |
| Flinders Fatigue Scale (FFS) | At baseline, Week 6, and Week 14. | The FFS is a brief self-rated questionnaire specifically designed to assess daytime fatigue associated with insomnia, commonly used for rapid screening of patients' fatigue levels. The scale comprises 7 items, primarily measuring fatigue characteristics over the past two weeks. The first six items are scored from 0 (not at all) to 4 (extremely severe), while the time period item is scored based on the number of time periods checked (1 point per time period). All item scores are summed to obtain the total score, which typically ranges from 0 to 31, with higher scores indicating greater severity of fatigue. |
| Generalized Anxiety Disorder-7 (GAD-7) | At baseline, Week 6, and Week 14. | The GAD-7 is used to evaluate the symptoms and severity of anxiety in patients. It includes 7 entries, each with a score of 0 to 3 and a total score between 0 and 21. Higher scores indicate greater anxiety severity. The commonly used classification criteria are as follows: 0-4 points (no or minimal anxiety), 5-9 points (mild anxiety), 10-14 points (moderate anxiety), and 15-21 points (severe anxiety). A total score of 10 or higher is generally indicated the possible presence of an anxiety disorder. |
| Patient Health Questionnaire-9 (PHQ-9) | At baseline, Week 6, and Week 14. | The PHQ-9 is used to assess the symptoms and severity of depression in patients. It consists of nine main entries, each with a score of 0 to 3 and a total score between 0 and 27. The score is generally used to determine the severity of depression: 0-4 points indicate no depression, 5-9 points indicate mild depression, 10-14 points indicate moderate depression, 15-19 points indicate moderately severe depression, and 20 or higher points indicate severe depression. |
| Therapeutic drug monitoring | Week 14. | All patients will undergo measurement of drug trough concentrations for IFX and VDZ at Week 14 of treatment. The concentration testing will be performed within 24 hours prior to the next scheduled infusion (i.e., close to the time of drug administration). |
| Fecal calprotectin (FC) | At baseline and Week 14. | FC is a widely used biomarker in the assessment and management of iIBD. As a stable protein released by activated neutrophils during intestinal inflammation, FC can effectively reflect the degree of mucosal inflammation non-invasively; elevated FC levels correlate with active intestinal inflammation, helping to distinguish between inflammatory bowel disease and functional gastrointestinal disorders such as irritable bowel syndrome. It also plays an important role in monitoring disease activity, evaluating treatment response, detecting early mucosal recurrence, and supporting clinical decision-making in patients with IBD. |
Countries
China
Outcome results
None listed