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Not yet recruiting NCT07383584

The Impact of Extending Sleep Before Joint-replacement Surgery on Post-surgical Pain

No phase Interventional Joint (Knee or Hip Replacement)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleep banking.
Who it may be relevant to
Registry conditions: Joint (Knee or Hip Replacement). Basic parameters: 18 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Sleep Banking Pre-Surgery for Improved Chronic Post-Surgical Pain: A Pilot Study

Overview

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.

Interventions

  • Behavioral Sleep banking
    The sleep extension group will add 2 hour of sleep per night the week before surgery

Primary outcome measures

  • Pain Intensity [Time frame: Weeks 1-15]
  • Pain Medication Use [Time frame: Weeks 1-15]
Secondary outcome measures (2)
  • Physical Function [Time frame: Weeks 1-15]
  • Sleep Disturbance [Time frame: Weeks 1-15]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Naval Medical Center San Diego — San Diego

Identifiers

NCT: NCT07383584 · USUHS 2025-158

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗