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OpenTrials
Active, Not Recruiting

NCT Number: NCT05828680

Circadian Rhythm Disruption in the Hospital Intensive Care Environment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Surgery Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observation

Other

No intervention

Primary outcomes

  1. Sleep depth

    Time frame: Up to 48 hours

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

Secondary outcomes

  1. 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).

  2. Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)

    Time frame: Up to 24 hours

    Variance in cognitive function

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 25, 2023
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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