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Can a computer program help MS patients sleep better?

NCT ID NCT06113666

Symptom relief Sponsor: St. Olavs Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a 9-week online cognitive behavioral therapy program can improve sleep in people with multiple sclerosis (MS). About 550 participants in Norway will either receive the digital therapy or digital education about insomnia. The main goal is to see if the therapy reduces insomnia severity, and also whether it helps with fatigue, mood, and thinking problems.

What this could mean

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

Active substance
digital cognitive behavioral therapy for insomnia (dCBT-I)
What this could lead to
If it works, this could provide an effective, accessible way to improve sleep and reduce fatigue for people with MS, without medication.
What could go wrong
This is a behavioral intervention, not a drug, so benefits may be modest. The trial is active but not recruiting, and results are not yet available.

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 550 people

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

Started

Nov 2023

Expected to finish

Jun 2031

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: 1. Having an established diagnosis of Multiple Sclerosis (MS) and being included in the Norwegian MS registry 2. Being 18 years or older 3. Scoring at least 12 points on the Insomnia Severity Index 4. Willing and able to provide written informed consent Exclusion Criteria: 1. Self-reported symptoms of sleep apnea: Positive endorsement of a screening question for sleep apnoea (the item asks if they 'usually or everyday snore and stop breathing and have difficulties staying awake during the day') 2. Self-reported surgery for heart disease the last two months 3. Currently in an attack phase of MS and/or on treatment with steroids, 4. Self-reported night shifts in their work schedule, 5. Inadequate opportunity to sleep or living in circumstances that prevent modification of sleep pattern (e.g. having an infant residing at home), 6. Pregnant in the last two trimesters 7. Unable to get into bed or out of bed without human assistance. 8. Concomitant psychological treatment for sleep problems

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Conditions

The condition(s) this trial relates to.

Fatigue insomnia multiple sclerosis

As listed by the trial registrant

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

Insomnia Multiple sclerosis

Contacts and locations

Locations

  • St.Olavs Hospital

    Trondheim, 7044, Norway

More trials for these conditions

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