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
About this trial
This is an interventional diagnostic trial for Irritable Bowel Syndrome focused on measuring visceral hypersensitivity, Insomnia
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
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
NCT ID
NCT04168047
First Posted
November 15, 2019
Last Updated
June 26, 2020
Sponsor
University Hospital, Rouen
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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