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Can better sleep ease Crohn's symptoms? new study investigates

NCT ID NCT05956158

Symptom relief Sponsor: Dartmouth-Hitchcock Medical Center 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study looks at whether treating insomnia can help people with Crohn's disease feel better, including reducing pain and inflammation. About 83 adults with mild to moderate Crohn's and insomnia will receive a remote sleep treatment. The main goal is to see if the approach is practical and acceptable, while also checking for improvements in sleep and Crohn's symptoms.

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

About 83 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Feb 2027

An estimate. End dates often move.

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Mild to moderate CD based on PRO-3 \& 50% with objective evidence of active disease * Insomnia Severity Index score ≥ 8 and SOL or WASO ≥ 30 minutes * Stability of sleep \& CD meds for ≥ 3 months * Access to internet or cell phone service sufficient for telehealth Exclusion Criteria: * PHQ-9 depression score ≥ 15 * GAD-7 anxiety score ≥ 15 * Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder) * Current alcohol or substance abuse * Current opioid use for pain control * Current systemic corticosteroid use * Current pregnancy or nursing * Ileostomy or colostomy * Diagnosis of seizure disorder * Diagnosis of sleep apnea or positive WatchPAT screen * Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen * Night shift, rotating shift work, or frequent travel outside of time zone

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Conditions

The condition(s) this trial relates to.

Crohn disease insomnia

As listed by the trial registrant

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

Crohn disease Insomnia

Contacts and locations

Locations

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

More trials for these conditions

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