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Could a simple sleep shortcut cure your insomnia? new trial tests group therapy in your Doctor's office

NCT ID NCT04975776

Symptom relief Sponsor: Region Stockholm 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a short, nurse-led group therapy based on sleep restriction can help people with insomnia. 104 adults with insomnia will either receive the sleep restriction program or standard sleep hygiene advice. The goal is to see if this simpler approach reduces insomnia severity and is cost-effective for routine primary care.

What this could mean

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

Active substance
sleep restriction therapy (a behavioral intervention that limits time in bed to improve sleep efficiency)
What this could lead to
If successful, this could offer a simpler, shorter insomnia treatment that primary care clinics can easily deliver in groups, helping more people without needing lengthy therapy.
What could go wrong
This is a relatively small trial (104 participants) testing a behavioral approach, not a drug. Results may not apply to everyone, and sleep restriction can be tough to follow, causing temporary daytime sleepiness or frustration.

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 104 people

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

Started

Feb 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Fulfills the DSM-5 diagnostic criteria for insomnia disorder: a) Difficulty initiating sleep, difficulty maintaining sleep, and early morning awakenings despite adequate opportunity for sleep (e.g., adequate time and circumstances for sleep and a safe, quiet, and dark bedroom). b) The sleep difficulties cause significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. c) The sleep difficulties occur at least 3 nights per week and have been present for at least 3 months. d) The symptoms are not better explained by and do not occur exclusively during the course of another sleep-wake disorder. e) The symptoms cannot be attributed to the effects of a substance (e.g., drug abuse and medication). f) Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia. Exclusion Criteria: * Severe psychiatric illness (e.g., severe depression, schizophrenia, bipolar disorder) * Suicidal ideation * Untreated sleep disorder other than insomnia (e.g., sleep apnea, and restless legs syndrome) * Epilepsy * Cognitive disorder * Pregnancy * Night shift work * Language difficulties (inability to understand and speak Swedish well enough to participate in the intervention and respond to measurement instruments) * ≤ 7 points on the Insomnia Severity Index

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

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

Insomnia

Contacts and locations

Locations

  • Christina Sandlund

    Stockholm, Stockholms Läns Landsting, 104 31, Sweden

More trials for these conditions

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