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Can a few therapy sessions ease jaw pain and improve sleep?

NCT ID NCT04897581

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two short behavioral therapies delivered over video calls for adults with chronic orofacial (jaw or face) muscle pain and insomnia. One therapy focuses on sleep habits and routines; the other uses jaw relaxation and breathing exercises. The goal is to see which approach better reduces pain and improves sleep and quality of life.

What this could mean

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

Active substance
Brief Behavioral Therapy for Insomnia (BBTI) and Physical Self-Regulation (PSR)
What this could lead to
If successful, this could point toward a simple, drug-free way to improve both sleep and pain in people with chronic jaw or facial muscle pain.
What could go wrong
This is a very small early study (19 people) comparing two behavioral approaches, so results may not apply broadly. Both interventions are brief and low-risk, but benefits may be modest.

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

19 people

The number who actually took part.

Started

Oct 2021

Finished

May 2023

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: * present with a score on Insomnia Severity Index \> 15 * have a primary diagnosis of chronic (onset more than 3 months before) MSK pain (myofascial pain and/or local myalgia and/or centrally mediated myalgia) from a board-certified orofacial pain specialist at UK Orofacial Pain Clinic * maintain a stable medication regime in previous month and during the intervention * older than 18 years old * able to understand English * willing to participate to telehealth intervention * have internet access and an email address * present with total STOP BANG score \< 5 Exclusion Criteria: * less than 18 years old * unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

anxiety disorder Depression Fatigue insomnia Myalgia myofascial pain syndrome Self-Control

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

More trials for these conditions

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