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Better sleep before surgery may ease pain afterward, new trial hopes to prove

NCT ID NCT06145516

Symptom relief Sponsor: Uppsala University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 helping people with insomnia sleep better before knee or hip replacement surgery can reduce pain and improve recovery afterward. One hundred adults scheduled for surgery will receive either cognitive behavioral therapy for insomnia or sleep education for four weeks before their operation. Researchers will track pain, sleep, and recovery for a year after surgery.

What this could mean

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

Active substance
Cognitive behavioral therapy for insomnia (CBT-I) and sleep education therapy
What this could lead to
If it works, this could point toward a simple, drug-free way to improve pain control and recovery after joint replacement surgery.
What could go wrong
This is a small, early-stage trial with only 100 participants. The sleep interventions may not significantly improve pain or recovery, and results may not apply to everyone.

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 100 people

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

Started

Sep 2025

Expected to finish

Dec 2030

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 to 100 years

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: * age ≥18 years * insomnia severity index score \>10 * fulfill DSM-V criteria for persistent insomnia disorder * average pain numerical rating scale (NRS) score ≥4 (scale 0 - 10) and/or movement-related pain NRS score ≥4 after 5 minutes walking * scheduled to undergo primary (first-time, i.e., not revision surgery) TKA or THA due to osteoarthritis Exclusion Criteria: * uncontrolled medical disorders * nightshift work * ongoing major depressive disorder, bipolar disorder, psychotic disorder, substance dependence * current history or high likelihood of primary sleep disorders (other than insomnia), including obstructive sleep apnea syndrome, narcolepsy, nocturnal myoclonus * severely impaired vision (precluding ability to take part of study interventions)

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Conditions

The condition(s) this trial relates to.

insomnia osteoarthritis osteoarthritis, hip osteoarthritis, knee Pain, Postoperative Parasomnias Postoperative Complications

As listed by the trial registrant

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

Insomnia Osteoarthritis, hip Osteoarthritis, knee Pain, postoperative Postoperative complications Surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Surgical Sciences, Uppsala University

    RECRUITING

    Uppsala, Uppland, 75185, Sweden

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