Irritable Bowel SyndromeS3iNCT04168047
Are Sleeping Disorders Associated With Visceral Hypersensitivity in Irritable Bowel Syndrome Patients ?
A study testing Barostat procedure, Anxiety and Depression Evaluation and Assessment of sleep quality in people with Irritable Bowel Syndrome, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Barostat procedure, Anxiety and Depression Evaluation and Assessment of sleep quality
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2020to 12 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Irritable Bowel Syndrome
- Being tested
- Barostat procedure, Anxiety and Depression Evaluation, Assessment of sleep quality
- Keywords
- visceral hypersensitivity, Insomnia
- Medical subject headings
- Irritable Bowel Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barostat procedureProcedure or surgery
Pressure threshold will be measured during the barostat procedure
Anxiety and Depression EvaluationOther
Anxiety and Depression will be measured using HAD anxiety and depression scale
Assessment of sleep qualityOther
Sleep quality will be measured using Pittsburg sleep quality index
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | Not described Receives: Procedure: Barostat procedure; Other: Anxiety and Depression Evaluation; Other: Assessment of sleep quality |
| Patients with insomnia | Other | Not described Receives: Procedure: Barostat procedure; Other: Anxiety and Depression Evaluation; Other: Assessment of sleep quality |
| Patients with irritable bowel syndrome | Other | Not described Receives: Procedure: Barostat procedure; Other: Anxiety and Depression Evaluation; Other: Assessment of sleep quality |
| Patients with irritable bowel syndrome and insomnia | Experimental | Not described Receives: Procedure: Barostat procedure; Other: Anxiety and Depression Evaluation; Other: Assessment of sleep quality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure threshold measured during the barostat procedure
Pressure threshold measured during the barostat procedure
Measured: Day 35
Secondary outcomes (2)
Score at HAD anxiety and depression scale
Score at HAD anxiety and depression scale
Measured: Day 35
Score at Pittsburg sleep quality index
Score at Pittsburg sleep quality index
Measured: Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start22 Sep 2020
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloé MECHIOR, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168047
- Sponsor's protocol ID
- 2016/381/HP
- Acronym
- S3i
- Status last verified
- Feb 2026
- First submitted
- 15 Nov 2019
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Sleeping Disorders Associated With Visceral Hypersensitivity in Irritable Bowel Syndrome Patients ?
- ClinicalTrials.gov ID
- NCT04168047
- Acronym / sponsor ID
- S3i / 2016/381/HP
- Conditions
- Irritable Bowel Syndrome
- Keywords
- visceral hypersensitivity, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Procedure: Barostat procedure, Other: Anxiety and Depression Evaluation, Other: Assessment of sleep quality |
| Patients with insomnia | Other | Procedure: Barostat procedure, Other: Anxiety and Depression Evaluation, Other: Assessment of sleep quality |
| Patients with irritable bowel syndrome | Other | Procedure: Barostat procedure, Other: Anxiety and Depression Evaluation, Other: Assessment of sleep quality |
| Patients with irritable bowel syndrome and insomnia | Experimental | Procedure: Barostat procedure, Other: Anxiety and Depression Evaluation, Other: Assessment of sleep quality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy volunteers
- Patients with insomnia
- Patients with IBS
- patients with insomnia and IBS - Patient aged over 18 years with IBS
Key exclusion criteria (15 listed)
- Active chronic organic disease
- Endometriosis
- Opioids consumption
- Change in chronic treatment in the last 30 days
- Hypersensitivity to Normacol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barostat procedurePressure threshold will be measured during the barostat procedure | Procedure or surgery | Healthy volunteers, Patients with insomnia, Patients with irritable bowel syndrome, Patients with irritable bowel syndrome and insomnia |
| Anxiety and Depression EvaluationAnxiety and Depression will be measured using HAD anxiety and depression scale | Other | Healthy volunteers, Patients with insomnia, Patients with irritable bowel syndrome, Patients with irritable bowel syndrome and insomnia |
| Assessment of sleep qualitySleep quality will be measured using Pittsburg sleep quality index | Other | Healthy volunteers, Patients with insomnia, Patients with irritable bowel syndrome, Patients with irritable bowel syndrome and insomnia |
Primary outcome
Pressure threshold measured during the barostat procedure
Time frame: Day 35
Pressure threshold measured during the barostat procedure
2 secondary outcomes
Score at HAD anxiety and depression scale
Time frame: Day 35
Score at Pittsburg sleep quality index
Time frame: Day 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chloé MECHIOR, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barostat procedure, Anxiety and Depression Evaluation and Assessment of sleep quality in people with Irritable Bowel Syndrome, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure threshold measured during the barostat procedure (time frame: Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.