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

Irritable Bowel Syndrome Clinical Trial

— S3i  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04168047
• Other study ID #: 2016/381/HP
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2020
• Est. completion date: August 2023

Study information

• Verified date: June 2020
• Source: University Hospital, Rouen
• Contact: Chloé MECHIOR, MD
• Phone: +3323288
• Email: chloe.melchior[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 77
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Irritable Bowel Syndrome
• Parasomnias
• Syndrome

Intervention

Procedure:
• Barostat procedure
Pressure threshold will be measured during the barostat procedure

Other:
• Anxiety and Depression Evaluation
Anxiety and Depression will be measured using HAD anxiety and depression scale
• Assessment of sleep quality
Sleep quality will be measured using Pittsburg sleep quality index

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure threshold measured during the barostat procedure	Pressure threshold measured during the barostat procedure	Day 35
Secondary	Score at HAD anxiety and depression scale	Score at HAD anxiety and depression scale	Day 35
Secondary	Score at Pittsburg sleep quality index	Score at Pittsburg sleep quality index	Day 35