Perioperative Sleep Quality and Postoperative Pain Outcomes

• Conditions: ACL Injury; Surgery; Sleep; Pain
• Interventions: Device: eCAP

• Registration Number: NCT06054802
• Lead Sponsor: Grant Heydinger

Brief Summary

This is a prospective, observational cohort study that will examine how sleep quality impacts postoperative pain and opioid consumption for pediatric patients. The investigators will administer a questionnaire preoperatively to determine which patients have poor or good sleep quality. They will then compare postoperative pain and opioid use between groups for two weeks following surgery. For a secondary aim, investigators will use electronic medication vials (eCAP) to monitor participants' medication use at home and compare to self-reporting.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-26
• Status Verified: 2025-02
• Study Start: 2025-02-03
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-03
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• able to read, understand, and speak English
• are undergoing ACL repair or reconstruction
• have availability of a mobile device/computer to receive text messages

Exclusion Criteria

• < 10 or > 18 years of age
• have a history of sleep-disordered breathing including sleep apnea
• have a history of chronic pain or current opioid use
• have a history of developmental delay that would preclude study participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ACL surgery	eCAP	Pediatric subjects undergoing surgery for ACL repair.

Primary Outcome Measures

Name	Time	Method
Difference in opioid consumption between self-report and eCap	Days 1-14 post-op	The eCAP Electronic Content Monitor (ECM) is a smart pill bottle used to monitor and improve medication adherence. When opened, an event is recorded, and the data is securely stored. The eCAP device timestamps medication usage and provides a visualization demonstrating how patients are taking medications, providing robust analytics. Subjects will also record each time they take an opioid pain medicine on a daily diary.
Pittsburgh Sleep Quality Index	Baseline	Pittsburgh Sleep Quality Index (PSQI) is a validated, self-report questionnaire that assesses sleep quality over a one-month period that takes five to ten minutes to complete. It offers seven component scores (e.g., subjective sleep quality, latency, duration, and efficiency) as well as a composite score that measures overall sleep quality. A total score greater than five yields a sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p \<0.001) in distinguishing good from poor sleepers.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States