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Insomnia linked to lower pain tolerance in IBS patients

NCT ID NCT04168047

Knowledge-focused Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether insomnia affects pain sensitivity in people with Irritable Bowel Syndrome (IBS). Researchers measured pain thresholds using a barostat procedure in 70 participants, including IBS patients with and without insomnia, healthy volunteers, and people with insomnia alone. The goal was to see if sleep problems are tied to lower pain tolerance, which could help guide future treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If confirmed, this could point to treating insomnia as a way to ease IBS-related pain.
What could go wrong
This is a small, completed observational study, not a treatment trial. Results may not lead to new therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

70 people

The number who actually took part.

Started

Sep 2020

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

insomnia irritable bowel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Irritable bowel syndrome

Contacts and locations

Locations

  • Rouen University Hospital

    Rouen, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.