Are Sleeping Disorders Associated With Visceral Hypersensitivity in Irritable Bowel Syndrome Patients ? (S3i)

University Hospital, Rouen

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Procedure: Barostat procedure; Other: Assessment of sleep quality; Other: Anxiety and Depression Evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT04168047

2016/381/HP

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 4 patient groups

Healthy volunteers

Other group

Treatment:

Other: Anxiety and Depression Evaluation

Other: Assessment of sleep quality

Procedure: Barostat procedure

Patients with insomnia

Other group

Treatment:

Other: Anxiety and Depression Evaluation

Other: Assessment of sleep quality

Procedure: Barostat procedure

Patients with irritable bowel syndrome

Other group

Treatment:

Other: Anxiety and Depression Evaluation

Other: Assessment of sleep quality

Procedure: Barostat procedure

Patients with irritable bowel syndrome and insomnia

Experimental group

Treatment:

Other: Anxiety and Depression Evaluation

Other: Assessment of sleep quality

Procedure: Barostat procedure