Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD

NCT07475052 | Enrolling By Invitation

• 1 other identifier: KY20252534
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease; Heart Rate Variability; Biologics; Prediction; Sleep Quality

Outcome Measures

Primary Outcomes (2)

• Disease activity

  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.

  At baseline, Week 2, Week 6, and Week 14.

• Heart Rate Variability

  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.

  At baseline, Week 2, Week 6, and Week 14.

Secondary Outcomes (8)

• Sleep Monitoring

  During 14 weeks of treatment.

• Pittsburgh Sleep Quality Index (PSQI)

  At baseline, Week 6, and Week 14.

• Insomnia Severity Index (ISI)

  At baseline, Week 6, and Week 14.

• Flinders Fatigue Scale (FFS)

  At baseline, Week 6, and Week 14.

• Generalized Anxiety Disorder-7 (GAD-7)

  At baseline, Week 6, and Week 14.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with IBD aged 18-75 years who initiate IFX or VDZ treatment for the first time will be recruited from Xijing hospital, Tang-Du hospital and Air Force 986 Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Xijing Hospital: lead
• Tang-Du Hospital: collaborator
• Air Force 986 Hospital: collaborator

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fecal, plasma and fixed tissue samples of some participants will be collected.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: March 16, 2026
• Study Start: December 25, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2025-12

Locations

CN (1)