Clinical Trials Directory

Trials / Completed

CompletedNCT04168047

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
University Hospital, Rouen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBarostat procedurePressure threshold will be measured during the barostat procedure
OTHERAnxiety and Depression EvaluationAnxiety and Depression will be measured using HAD anxiety and depression scale
OTHERAssessment of sleep qualitySleep quality will be measured using Pittsburg sleep quality index

Timeline

Start date
2020-09-22
Primary completion
2025-11-12
Completion
2025-11-12
First posted
2019-11-19
Last updated
2026-02-06

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04168047. Inclusion in this directory is not an endorsement.