Circadian Rhythm Disruption in the Hospital Intensive Care Environment

NCT05828680 | Active Not Recruiting

• 1 other identifier: 852451
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Sleep depth

  Variance in sleep depth assessed as percent REM sleep of total sleep time (TST)

  Up to 48 hours

Secondary Outcomes (4)

• Odds Ratio Product-based sleep depth

  Up to 48 hours

• Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)

  Up to 24 hours

• Number of recorded patient visits

  24 hours

• Purpose of recorded patient visits

  24 hours

Study Arms (1)

Elective cardiac surgery

Other: Observation

Interventions

Observation OTHER

No intervention

Elective cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential patients will be screened from outpatient clinic schedules from cardiac surgery appointments within the Perelman Center for Advanced Medicine. Patients for whom cardiac surgery is advised and who meet eligibility criteria will be approached and enrolled after their consultation with the surgeon.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Carsten Skarke, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Garret A FitzGerald, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 25, 2023
• Study Start: March 15, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)