Are Sleeping Disorders Associated With Visceral Hypersensitivity in Irritable Bowel Syndrome Patients ?
NCT ID: NCT04168047
Last Updated: 2020-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
77 participants
INTERVENTIONAL
2020-07-31
2023-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Healthy volunteers
Barostat procedure
Pressure threshold will be measured during the barostat procedure
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
Patients with insomnia
Barostat procedure
Pressure threshold will be measured during the barostat procedure
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
Patients with irritable bowel syndrome
Barostat procedure
Pressure threshold will be measured during the barostat procedure
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
Patients with irritable bowel syndrome and insomnia
Barostat procedure
Pressure threshold will be measured during the barostat procedure
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
Interventions
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Barostat procedure
Pressure threshold will be measured during the barostat procedure
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
Eligibility Criteria
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Inclusion Criteria
\- 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
* 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
18 Years
ALL
Yes
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Chloé MECHIOR, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Rouen University Hospital
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Chloé MELCHIOR, MD
Role: primary
Other Identifiers
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2016/381/HP
Identifier Type: -
Identifier Source: org_study_id
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