Circadian Rhythm Disruption in the Hospital Intensive Care Environment

University of Pennsylvania

Status: Active, not recruiting

Conditions: Surgery; Cardiovascular Diseases

Treatments: Other: Observation

Study type: Observational

Funder types: Other

Identifiers

NCT05828680

852451

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 1 patient group

Elective cardiac surgery

Treatment:

Other: Observation