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

Not Applicable

• Conditions: Irritable Bowel Syndrome
• Interventions: Procedure: Barostat procedure; Other: Anxiety and Depression Evaluation; Other: Assessment of sleep quality

• Registration Number: NCT04168047
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-19
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-29
• Study Start: 2020-07
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with irritable bowel syndrome	Assessment of sleep quality	-
Healthy volunteers	Anxiety and Depression Evaluation	-
Patients with insomnia	Barostat procedure	-
Patients with irritable bowel syndrome	Barostat procedure	-
Patients with irritable bowel syndrome and insomnia	Anxiety and Depression Evaluation	-
Healthy volunteers	Barostat procedure	-
Patients with insomnia	Assessment of sleep quality	-
Healthy volunteers	Assessment of sleep quality	-
Patients with insomnia	Anxiety and Depression Evaluation	-
Patients with irritable bowel syndrome	Anxiety and Depression Evaluation	-
Patients with irritable bowel syndrome and insomnia	Barostat procedure	-
Patients with irritable bowel syndrome and insomnia	Assessment of sleep quality	-

Primary Outcome Measures

Name	Time	Method
Pressure threshold measured during the barostat procedure	Day 35	Pressure threshold measured during the barostat procedure

Secondary Outcome Measures

Name	Time	Method
Score at HAD anxiety and depression scale	Day 35	Score at HAD anxiety and depression scale
Score at Pittsburg sleep quality index	Day 35	Score at Pittsburg sleep quality index

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France