Multimodal Sleep Pathway for Shoulder Arthroplasty

Phase 1

Completed

• Conditions: Shoulder Arthritis; Perioperative/Postoperative Complications; Arthroplasty Complications; Sleep Disturbance
• Interventions: Drug: Zolpidem

• Registration Number: NCT03269760
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-08-30
• Study Start: 2017-09-01
• Study First Posted: 2017-09-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

All consenting adults undergoing elective total shoulder replacement

Exclusion Criteria

• Allergies to zolpidem or refusal to participate in study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Sleep Medicine	Zolpidem	Use of a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem to improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.

Primary Outcome Measures

Name	Time	Method
Lead's Sleep scale	postoperative day 1	Patient reported outcome

Secondary Outcome Measures

Name	Time	Method
Sleep journals	postoperative day 1-7	patient reported outcome
Pain scores	postoperative day 1	\]pain scores

Trial Locations

Locations (1)

Ucsf; 🇺🇸 San Francisco, California, United States