The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05828680
Recruitment Status : Enrolling by invitation
First Posted : April 25, 2023
Last Update Posted : April 25, 2023
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
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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.
Surgery Cardiovascular Diseases
Other: Observation
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Study Type :
Observational
Estimated Enrollment :
10 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Circadian Rhythm Disruption in the Hospital Intensive Care Environment
Actual Study Start Date :
March 15, 2023
Estimated Primary Completion Date :
March 2025
Estimated Study Completion Date :
March 2026
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Elective cardiac surgery
Other: Observation
No intervention
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Primary Outcome Measures :
Sleep depth [ Time Frame: Up to 48 hours ]
Variance in sleep depth assessed as percent REM sleep of total sleep time (TST)
Secondary Outcome Measures :
Odds Ratio Product-based sleep depth [ Time Frame: 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).
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA) [ Time Frame: Up to 24 hours ]
Variance in cognitive function
Number of recorded patient visits [ Time Frame: 24 hours ]
Any patient visits by physicians, nurses, maintenance and cleaning staff, family members and friends are documented
Purpose of recorded patient visits [ Time Frame: 24 hours ]
The rationale is documented descriptively for each patient visits by physicians, nurses, maintenance and cleaning staff, family members and friends
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Information from the National Library of Medicine
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Ages Eligible for Study: Â
18 Years and older  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Sampling Method: Â
Non-Probability Sample
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.
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.
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05828680
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Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania
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Principal Investigator:
Carsten Skarke, MD
University of Pennsylvania
Principal Investigator:
Garret A FitzGerald, MD
University of Pennsylvania
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Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05828680 Â Â
Other Study ID Numbers:
852451
First Posted:
April 25, 2023 Â Â Key Record Dates
Last Update Posted:
April 25, 2023
Last Verified:
April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Undecided
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
