Circadian Rhythm Disruption in the Hospital Intensive Care Environment

Active, not recruiting

• Conditions: Cardiovascular Diseases; Surgery
• Interventions: Other: Observation

• Registration Number: NCT05828680
• Lead Sponsor: University of Pennsylvania

Brief Summary

Abrupt changes to one's lifestyle disrupt biorhythms. Acute effects are well known from jet lag where transmeridian travel leads to insomnia, fatigue, irritability, gastrointestinal symptoms and other complaints. Several studies in the hospital environment reported dampened and misaligned biorhythms, suggesting that the inpatient experience is replete with circadian disruptors. However, comprehensive assessments of how circadian clocks are affected in intensive care and how this predicts post-operative recovery and risk are largely missing.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-15
• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Adults scheduled for cardiac surgery;
• ≥18 years of age;
• Capable of giving informed consent;
• Own a smartphone (Apple devices only).

Exclusion Criteria

• Taking sleep aids (antihistamines, melatonin, etc.)
• History of alcohol abuse (more than 2 drinks a day with last drink within the past 3 days)
• History of substance abuse at risk of postoperative withdrawal;
• Active diagnosis of alcohol or substance abuse;
• Recent travel across more than two (2) time zones (within the past month);
• Planned travel across more than two (2) time zones during the planned study activities;
• Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening;
• Subjects without access to WiFi in their or close to home or at work;
• Patients with hearing aids;
• Heart transplant patients;
• Patients in isolation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elective cardiac surgery	Observation	-

Primary Outcome Measures

Name	Time	Method
Sleep depth	Up to 48 hours	Variance in sleep depth assessed as percent REM sleep of total sleep time (TST)

Secondary Outcome Measures

Name	Time	Method
Purpose of recorded patient visits	24 hours	The rationale is documented descriptively for each patient visits by physicians, nurses, maintenance and cleaning staff, family members and friends
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)	Up to 24 hours	Variance in cognitive function
Odds Ratio Product-based sleep depth	Up to 48 hours	Variance in sleep depth assessed as Odds Ratio Product (ORP) which ranges between ORP=0 (deeply asleep) and ORB=2.5 (fully awake).
Number of recorded patient visits	24 hours	Any patient visits by physicians, nurses, maintenance and cleaning staff, family members and friends are documented

Trial Locations

Locations (1)

Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States