Are Sleeping Disorders Associated With Visceral Hypersensitivity in Irritable Bowel Syndrome Patients ? (S3i)

Visceral hypersensitivity is frequent in IBS population up to 60% and is correlated with severity and altered quality of life. Sleeping troubles are most frequent in IBS population. Insomnia is a frequent disorder with an important cost for healthcare. Insomnia could decrease pain threshold.

Visceral hypersensitivity was never measure in patients with insomnia. The hypothesis is IBS patients with insomnia probably have lower visceral pain threshold.

The objective is to assess pain threshold during a barostat procedure in in IBS patients with or without insomnia in comparison with healthy volunteers or patients with insomnia.

If the hypothesis are confirmed, insomnia should be look at in IBS patients and its treatments could improve visceral hypersensitivity and IBS symptoms.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Procedure: Barostat procedure; Other: Anxiety and Depression Evaluation; Other: Assessment of sleep quality

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy volunteers

   - Person aged over 18 years with no IBS and no Insomnia

2. Patients with insomnia

   - Patient aged over 18 years with no IBS and no Insomnia

3. Patients with IBS

   - Patient aged over 18 years with IBS

4. patients with insomnia and IBS - Patient aged over 18 years with IBS

Exclusion Criteria:

• Active chronic organic disease
• Endometriosis
• Opioids consumption
• Change in chronic treatment in the last 30 days
• Hypersensitivity to Normacol
• Patient with blood dyscrasia disorder known or identified, anticoagulant or antiplatelet treatments
• Rectal pathology
• Intestinal occlusion
• Severe renal failure
• Sodium retention
• Anal pathology (anal fissure, hemorrhoidal thrombosis)
• Person with administrative or judicial decision or under legal protection measure
• Patient participating in another trial in the last 30 days
• Pregnant or breastfeeding women
• Impossibility to keep fasting for 12 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy volunteers	Procedure: Barostat procedure; Pressure threshold will be measured during the barostat procedure; Other: Anxiety and Depression Evaluation; Anxiety and Depression will be measured using HAD anxiety and depression scale; Other: Assessment of sleep quality; Sleep quality will be measured using Pittsburg sleep quality index
Other: Patients with insomnia	Procedure: Barostat procedure; Pressure threshold will be measured during the barostat procedure; Other: Anxiety and Depression Evaluation; Anxiety and Depression will be measured using HAD anxiety and depression scale; Other: Assessment of sleep quality; Sleep quality will be measured using Pittsburg sleep quality index
Other: Patients with irritable bowel syndrome	Procedure: Barostat procedure; Pressure threshold will be measured during the barostat procedure; Other: Anxiety and Depression Evaluation; Anxiety and Depression will be measured using HAD anxiety and depression scale; Other: Assessment of sleep quality; Sleep quality will be measured using Pittsburg sleep quality index
Experimental: Patients with irritable bowel syndrome and insomnia	Procedure: Barostat procedure; Pressure threshold will be measured during the barostat procedure; Other: Anxiety and Depression Evaluation; Anxiety and Depression will be measured using HAD anxiety and depression scale; Other: Assessment of sleep quality; Sleep quality will be measured using Pittsburg sleep quality index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure threshold measured during the barostat procedure	Pressure threshold measured during the barostat procedure	Day 35

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score at HAD anxiety and depression scale	Score at HAD anxiety and depression scale	Day 35
Score at Pittsburg sleep quality index	Score at Pittsburg sleep quality index	Day 35

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Chloé MECHIOR, MD, University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Actual): November 12, 2025
• Study Completion (Actual): November 12, 2025

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Insomnia; visceral hypersensitivity
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Sleep Wake Disorders; Colonic Diseases, Functional; Sleep Disorders, Intrinsic; Dyssomnias; Irritable Bowel Syndrome; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2016/381/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No