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Multimodal Sleep Pathway for Shoulder Arthroplasty

Advancing the Multimodal Pathway: Investigating the Use of Sleep and Zolpidem in the Recovery After Shoulder Arthroplasty

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03269760
Enrollment
122
Registered
2017-09-01
Start date
2017-09-01
Completion date
2020-02-01
Last updated
2020-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Complications, Perioperative/Postoperative Complications, Shoulder Arthritis, Sleep Disturbance

Brief summary

The purpose of the study is to investigate the efficacy of sleep medicine in the recovery of orthopaedic shoulder arthroplasty patients. The investigators hypothesize that a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem can improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.

Detailed description

Shoulder pain at night is a common symptom of shoulder arthritis and contributes to sleep disturbances. Many patients also have difficulty sleeping after shoulder surgery due to the constraints of sling immobilization. While in the hospital, sleep is also disrupted due to pain, nursing staff, other patients, and bathroom use. While poor sleep may appear trivial, sleep deprivation in animal models has identified significant adverse effects on bone metabolism, bone mass, and recovery from post surgical pain. Recent evidence has shown that non-pharmacological sleep interventions that improve sleep hygiene and duration can optimize athletic peak performance, fatigue, and recovery. Furthermore, pharmacological sleep aid use with zolpidem in orthopaedic postoperative patients has suggested safe administration, improved pain control, reduced pain medication use, and higher patient satisfaction in the settings of total knee and hip arthroplasty, rotator cuff repairs, and ACL reconstruction. The purpose of the study is to investigate the efficacy of sleep medicine in the recovery of orthopaedic shoulder arthroplasty patients. The investigators hypothesize that a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem can improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.

Interventions

DRUGZolpidem

Addition of both non-pharmacologic nursing directed sleeping hygiene practices with pharmacologic zolpidem to improve sleep latency

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

All consenting adults undergoing elective total shoulder replacement \-

Exclusion criteria

* Allergies to zolpidem or refusal to participate in study

Design outcomes

Primary

MeasureTime frameDescription
Lead's Sleep scalepostoperative day 1Patient reported outcome

Secondary

MeasureTime frameDescription
Sleep journalspostoperative day 1-7patient reported outcome
Pain scorespostoperative day 1\]pain scores

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026