Circadian Rhythm Disruption in the Hospital Intensive Care Environment

Cardiovascular Diseases Clinical Trial

Official title:

Circadian Rhythm Disruption in the Hospital Intensive Care Environment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05828680
• Other study ID #: 852451
• Status: Enrolling by invitation
• Start date: March 15, 2023
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Surgery

Intervention

Other:
• Observation
No intervention

Locations

Country	Name	City	State
United States	Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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