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

Study Overview
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Brief Summary
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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.

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

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Procedure: Barostat procedure
* Other: Anxiety and Depression Evaluation
* Other: Assessment of sleep quality


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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visceral hypersensitivity, Insomnia