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

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Barostat procedure
Anxiety and Depression Evaluation
Assessment of sleep quality
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Irritable Bowel Syndrome focused on measuring visceral hypersensitivity, Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Rouen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Experimental

Arm Label

Healthy volunteers

Patients with insomnia

Patients with irritable bowel syndrome

Patients with irritable bowel syndrome and insomnia

Arm Description

Outcomes

Primary Outcome Measures

Pressure threshold measured during the barostat procedure
Pressure threshold measured during the barostat procedure

Secondary Outcome Measures

Score at HAD anxiety and depression scale
Score at HAD anxiety and depression scale
Score at Pittsburg sleep quality index
Score at Pittsburg sleep quality index

Full Information

First Posted
November 15, 2019
Last Updated
June 26, 2020
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT04168047
Brief Title
Are Sleeping Disorders Associated With Visceral Hypersensitivity in Irritable Bowel Syndrome Patients ?
Acronym
S3i
Official Title
Are Sleeping Disorders Associated With Visceral Hypersensitivity in Irritable Bowel Syndrome Patients ?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
visceral hypersensitivity, Insomnia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Other
Arm Title
Patients with insomnia
Arm Type
Other
Arm Title
Patients with irritable bowel syndrome
Arm Type
Other
Arm Title
Patients with irritable bowel syndrome and insomnia
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Barostat procedure
Intervention Description
Pressure threshold will be measured during the barostat procedure
Intervention Type
Other
Intervention Name(s)
Anxiety and Depression Evaluation
Intervention Description
Anxiety and Depression will be measured using HAD anxiety and depression scale
Intervention Type
Other
Intervention Name(s)
Assessment of sleep quality
Intervention Description
Sleep quality will be measured using Pittsburg sleep quality index
Primary Outcome Measure Information:
Title
Pressure threshold measured during the barostat procedure
Description
Pressure threshold measured during the barostat procedure
Time Frame
Day 35
Secondary Outcome Measure Information:
Title
Score at HAD anxiety and depression scale
Description
Score at HAD anxiety and depression scale
Time Frame
Day 35
Title
Score at Pittsburg sleep quality index
Description
Score at Pittsburg sleep quality index
Time Frame
Day 35

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chloé MECHIOR, MD
Phone
+3323288
Ext
8990
Email
chloe.melchior@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Phone
+3323288
Ext
8265
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chloé MECHIOR, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloé MELCHIOR, MD
First Name & Middle Initial & Last Name & Degree
Marie NETCHITAILO, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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