Joint (Knee or Hip Replacement)NCT07383584
The Impact of Extending Sleep Before Joint-replacement Surgery on Post-surgical Pain
A study testing Sleep banking in people with Joint (Knee or Hip Replacement), run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
Trial summary
This study will evaluate the impact of sleep banking on joint replacement surgery recovery. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Joint (Knee or Hip Replacement)
- What is being tested?
- Sleep banking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals scheduled for a joint replacement surgery (knee or hip) at Naval Medical Center San Diego
- Aged 18-74 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
DVCIPM Clinical Research Nurse Manager, alexandra.kane.ctr@usuhs.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Joint (Knee or Hip Replacement)
- Being tested
- Sleep banking
- Keywords
- sleep banking, sleep extension, chronic pain, recovery
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep bankingBehavioural
The sleep extension group will add 2 hour of sleep per night the week before surgery
| Study group | Role | What they receive |
|---|---|---|
| Sleep extension | Experimental | The sleep extension group will add 2 h of sleep per night the week before surgery Receives: Behavioral: Sleep banking |
| Habitual sleep | No intervention | The habitual sleep group maintain their usual hours of sleep per night the week before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Defense and Veterans Pain Rating Scale. On a scale of 0-10, with higher scores denoting more pain.
Measured: Weeks 1-15
Pain Medication Use
Opioid Use Diary
Measured: Weeks 1-15
Secondary outcomes (2)
Physical Function
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.
Measured: Weeks 1-15
Sleep Disturbance
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.
Measured: Weeks 1-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint (Knee or Hip Replacement)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sleep banking compared to sleep as usual (no intervention)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Defense and Veterans Center for Integrative Pain Management
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383584
- Sponsor's protocol ID
- USUHS 2025-158
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Banking Pre-Surgery for Improved Chronic Post-Surgical Pain: A Pilot Study
- ClinicalTrials.gov ID
- NCT07383584
- Acronym / sponsor ID
- USUHS 2025-158
- Conditions
- Joint (Knee or Hip Replacement)
- Keywords
- sleep banking, sleep extension, chronic pain, recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Defense and Veterans Center for Integrative Pain ManagementUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the impact of sleep banking on joint replacement surgery recovery.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Sleep banking compared to sleep as usual (no intervention)
| Arm | Type | Receives |
|---|---|---|
| Sleep extension | Experimental | Behavioral: Sleep bankingThe sleep extension group will add 2 h of sleep per night the week before surgery |
| Habitual sleep | No intervention | –The habitual sleep group maintain their usual hours of sleep per night the week before surgery |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals scheduled for a joint replacement surgery (knee or hip) at Naval Medical Center San Diego
- Aged 18-74 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep bankingThe sleep extension group will add 2 hour of sleep per night the week before surgery | Behavioural | Sleep extension |
Primary outcome
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.
Pain Medication Use
Time frame: Weeks 1-15
Opioid Use Diary
2 secondary outcomes
Physical Function
Time frame: Weeks 1-15
Sleep Disturbance
Time frame: Weeks 1-15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Joint (Knee or Hip Replacement)
Recruiting
Virtual Reality Therapy to Improve Arthroplasty Outcomes
Surgical, Anxiety
Recruiting
Evaluation of Choose to Move Replacement Ready (CTM-RR)
Osteoarthritis (OA), Osteoarthritis (OA) of the Hip
Enrolling by invitationPhase 4
Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Infections Joint Prosthetic, Overweight or Obesity
RecruitingObservational study
Heidelberg Registry for Hip and Knee Joint Implants and Revisions
Osteoarthritis, Arthroplasty
Active, not recruiting
Comparison Between Blocks or Not in Joint Arthroplasty
Osteoarthritis of the Knee or Hip
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep banking in people with Joint (Knee or Hip Replacement), run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary McDuffie, MS RN (3015388785, mary.mcduffie.ctr@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Weeks 1-15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.