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Completed

NCT Number: NCT04168047

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Dyssomnias Gastrointestinal Diseases Intestinal Diseases Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Barostat procedure

Procedure

Pressure threshold will be measured during the barostat procedure

Anxiety and Depression Evaluation

Other

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

Assessment of sleep quality

Other

Sleep quality will be measured using Pittsburg sleep quality index

Primary outcomes

  1. Pressure threshold measured during the barostat procedure

    Time frame: Day 35

    Pressure threshold measured during the barostat procedure

Secondary outcomes

  1. Score at HAD anxiety and depression scale

    Time frame: Day 35

    Score at HAD anxiety and depression scale

  2. Score at Pittsburg sleep quality index

    Time frame: Day 35

    Score at Pittsburg sleep quality index

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: S3i

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2019
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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