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Can sleep coaching speed recovery after joint replacement?

NCT ID NCT04269239

Symptom relief Sponsor: Baylor College of Medicine 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether coaching older adults in healthy habits or sleep habits can improve their recovery after hip or knee replacement surgery. Participants receive four hour-long sessions with a therapist, focusing either on general healthy habits like physical activity and nutrition, or on sleep-specific strategies like sleep restriction and stimulus control. Researchers will measure sleep quality and other physical and cognitive outcomes to see if either approach helps.

What this could mean

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

Active substance
Behavioral coaching sessions on healthy habits or sleep habits
What this could lead to
If it works, this could point toward a simple, non-drug way to improve sleep and recovery for older adults after joint replacement surgery.
What could go wrong
This is a small early-stage trial, so the benefits may not hold up in larger groups. The coaching requires time and effort, and results may vary from person to person.

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

73 people

The number who actually took part.

Started

Apr 2021

Finished

Nov 2024

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

40 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. Patients with a minimum age of 40 years, no maximum age limit, planning on having a hip or knee arthroplasty. 2. The ability to communicate during the screening process (e.g., no aphasia or other severe language impairment). 3. Meet DSM-5 criteria for insomnia disorder assessed by Duke Structured Interview for Sleep Disorders. 4. Score ≥8 on the Insomnia Severity Index (ISI) or ≥5 on the Pittsburgh Sleep Quality Index (PSQI). 5. Referral and attendance of medical rehabilitation post-discharge. Exclusion Criteria: 1. Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year). 2. Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities such as depression or anxiety will not be excluded). 3. Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk. 4. Cognitive impairment defined as \<20 on the Mini Mental Status Exam (MMSE) that could potentially limit comprehension of the intervention. Note, while an MMSE of \<24 is often used as a cutoff for cognitive impairment, we do not wish to exclude those with mild cognitive problems from this study as there is evidence that individuals with mild cognitive problems still benefit from insomnia treatments.

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Conditions

The condition(s) this trial relates to.

insomnia osteoarthritis, hip osteoarthritis, knee Pain

As listed by the trial registrant

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

Insomnia Osteoarthritis hip Osteoarthritis,knee Pain

Contacts and locations

Locations

  • Baylor College of Medicine Medical Center

    Houston, Texas, 77030, United States

  • Kelsey Seybold Clinic

    Houston, Texas, 77054, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

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