NCT04168047

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

September 22, 2020

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2025

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

5.1 years

First QC Date

November 15, 2019

Last Update Submit

February 5, 2026

Conditions

Irritable Bowel Syndrome

Keywords

visceral hypersensitivityInsomnia

Outcome Measures

Primary Outcomes (1)

  • Pressure threshold measured during the barostat procedure

    Pressure threshold measured during the barostat procedure

    Day 35

Secondary Outcomes (2)

  • Score at HAD anxiety and depression scale

    Day 35

  • Score at Pittsburg sleep quality index

    Day 35

Study Arms (4)

Healthy volunteers

OTHER
Procedure: Barostat procedureOther: Anxiety and Depression EvaluationOther: Assessment of sleep quality

Patients with insomnia

OTHER
Procedure: Barostat procedureOther: Anxiety and Depression EvaluationOther: Assessment of sleep quality

Patients with irritable bowel syndrome

OTHER
Procedure: Barostat procedureOther: Anxiety and Depression EvaluationOther: Assessment of sleep quality

Patients with irritable bowel syndrome and insomnia

EXPERIMENTAL
Procedure: Barostat procedureOther: Anxiety and Depression EvaluationOther: Assessment of sleep quality

Interventions

Barostat procedurePROCEDURE

Pressure threshold will be measured during the barostat procedure

Healthy volunteersPatients with insomniaPatients with irritable bowel syndromePatients with irritable bowel syndrome and insomnia
Anxiety and Depression EvaluationOTHER

Anxiety and Depression will be measured using HAD anxiety and depression scale

Healthy volunteersPatients with insomniaPatients with irritable bowel syndromePatients with irritable bowel syndrome and insomnia
Assessment of sleep qualityOTHER

Sleep quality will be measured using Pittsburg sleep quality index

Healthy volunteersPatients with insomniaPatients with irritable bowel syndromePatients with irritable bowel syndrome and insomnia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers
  • \- Person aged over 18 years with no IBS and no Insomnia
  • Patients with insomnia
  • \- Patient aged over 18 years with no IBS and no Insomnia
  • Patients with IBS
  • \- Patient aged over 18 years with IBS
  • patients with insomnia and IBS - Patient aged over 18 years with IBS

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Chloé MECHIOR, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 19, 2019

Study Start

September 22, 2020

Primary Completion

November 12, 2025

Study Completion

November 12, 2025

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)