- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07383584
The Impact of Extending Sleep Before Joint-replacement Surgery on Post-surgical Pain
February 11, 2026 updated by: Defense and Veterans Center for Integrative Pain Management
Sleep Banking Pre-Surgery for Improved Chronic Post-Surgical Pain: A Pilot Study
This study will evaluate the impact of sleep banking on joint replacement surgery recovery.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Sleep is emerging as a target for pain management.
The purpose of this study is to determine the feasibility and efficacy of extending sleep (sleep "banking") on self-reported pain outcomes post-surgery.
This is a prospective, interventional, between-subjects, randomized study with a control condition.
Participants will be patients undergoing knee or hip replacement surgery at Naval Medical Center San Diego.
Participants will be randomized to either a sleep banking group, where they attempt to extend nightly sleep in the week leading up to surgery, or to a habitual sleep control group, sleeping in their typical pattern for that same period.
Sleep and pain will be monitored daily yn the two weeks pre- and one week post-surgery.
After that, they will be sent electronic follow-up sleep and pain questionnaires at 1, 3, 6, 9, and 12 weeks post-surgery.
Participants in the sleep banking group will also complete additional questionnaire items on the feasibility and implementation of the sleep banking protocol.
Feasibility of sleep banking will be assessed by examination of the sleep between groups during the intervention week, as well as by the analysis of the implementation questions.
Efficacy will be assessed by examination of self-reported pain outcomes post-surgery by group.
The primary hypothesis is that self-reported pain outcomes will be improved in the sleep banking group as compared to the control group.
Study Type
Interventional
Enrollment (Estimated)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mary McDuffie, MS RN
- Phone Number: 3015388785
- Email: mary.mcduffie.ctr@usuhs.edu
Study Locations
-
-
California
-
San Diego, California, United States, 92134
- Naval Medical Center San Diego
-
Contact:
- DVCIPM Clinical Research Nurse Manager
- Email: alexandra.kane.ctr@usuhs.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Individuals scheduled for a joint replacement surgery (knee or hip) at Naval Medical Center San Diego
- Aged 18-74 years
Exclusion Criteria:
- Individuals < 18 or >74 years of age at enrollment
- Individuals diagnosed with untreated sleep disorders
- Individuals with scheduled timezone travel or work schedule changes (>/= 3 hour time change) in the two weeks before surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sleep extension
The sleep extension group will add 2 h of sleep per night the week before surgery
|
The sleep extension group will add 2 hour of sleep per night the week before surgery
|
|
No Intervention: Habitual sleep
The habitual sleep group maintain their usual hours of sleep per night the week before surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Weeks 1-15
|
Defense and Veterans Pain Rating Scale.
On a scale of 0-10, with higher scores denoting more pain.
|
Weeks 1-15
|
|
Pain Medication Use
Time Frame: Weeks 1-15
|
Opioid Use Diary
|
Weeks 1-15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Function
Time Frame: Weeks 1-15
|
Patient-Reported Outcomes Measurement Information System (PROMIS) -29 Adult Profile 2.0 Instrument, Physical Function subscale.
Each item is scored on a scale 1-5, with 1=without any difficulty and 5=unable to do.
Items will be summed and t-scored (0-100), with higher scores denoting less function.
|
Weeks 1-15
|
|
Sleep Disturbance
Time Frame: Weeks 1-15
|
Patient-Reported Outcomes Measurement Information System (PROMIS) -29 Adult Profile 2.0 Instrument, Sleep Disturbance subscale.
Each item is scored on a scale 1-5, with 1=not at all and 5=very much.
Items will be summed and t-scored (0-100), with higher scores denoting more sleep disturbance.
|
Weeks 1-15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 15, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Study Registration Dates
First Submitted
January 26, 2026
First Submitted That Met QC Criteria
January 26, 2026
First Posted (Actual)
February 3, 2026
Study Record Updates
Last Update Posted (Actual)
February 12, 2026
Last Update Submitted That Met QC Criteria
February 11, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USUHS 2025-158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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