Irritable Bowel Syndrome
Conditions
Keywords
visceral hypersensitivity, Insomnia
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.
Interventions
PROCEDUREBarostat procedure
Pressure threshold will be measured during the barostat procedure
OTHERAnxiety and Depression Evaluation
Anxiety and Depression will be measured using HAD anxiety and depression scale
Sleep quality will be measured using Pittsburg sleep quality index
Sponsors
University Hospital, Rouen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure threshold measured during the barostat procedure | Day 35 | Pressure threshold measured during the barostat procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORChloé MECHIOR, MD
University Hospital, Rouen
Outcome results
None listed