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Multimodal Sleep Pathway for Shoulder Arthroplasty

NCT03269760 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2020-05-27

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Zolpidem

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2020-02-01
Completion
2020-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03269760 on ClinicalTrials.gov