SurgeryNCT05828680
Circadian Rhythm Disruption in the Hospital Intensive Care Environment
An observational study of Surgery and Cardiovascular Diseases, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Cardiovascular Diseases
- What is being tested?
- Observation
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Adults scheduled for cardiac surgery;
- ≥18 years of age;
- Capable of giving informed consent;
- Own a smartphone (Apple devices only).
Who cannot join
- 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;
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
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
- Being tested
- Observation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Elective cardiac surgery | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep depth
Variance in sleep depth assessed as percent REM sleep of total sleep time (TST)
Measured: Up to 48 hours
Secondary outcomes (4)
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).
Measured: Up to 48 hours
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
Variance in cognitive function
Measured: Up to 24 hours
Number of recorded patient visits
Any patient visits by physicians, nurses, maintenance and cleaning staff, family members and friends are documented
Measured: 24 hours
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start15 Mar 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carsten Skarke, MD, Principal investigator, University of PennsylvaniaGarret A FitzGerald, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828680
- Sponsor's protocol ID
- 852451
- Status last verified
- Jan 2026
- First submitted
- 30 Mar 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Skarke C, El Jamal N, Genuardi MV, Brooks TG, Mrcela A, Lahens NF, Cordoza M, Sarles S, Mbadugha A, Karunamuni DR, Gupta S, Bae CJ, Sehgal A, Cappola TP, Gutsche JT, Atluri P, Desai ND, Acker MA, Grant GR, Schwab RJ, Rosen IM, FitzGerald GA. Quantifying sleep wake rhythms in the hospital environment with digital technologies. NPJ Digit Med. 2026 Apr 21;9(1):479. doi: 10.1038/s41746-026-02639-w.
PubMed 42014445
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Rhythm Disruption in the Hospital Intensive Care Environment
- ClinicalTrials.gov ID
- NCT05828680
- Acronym / sponsor ID
- 852451
- Conditions
- Surgery, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective cardiac surgery | – | Other: Observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adults scheduled for cardiac surgery;
- ≥18 years of age;
- Capable of giving informed consent;
- Own a smartphone (Apple devices only).
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationNo intervention | Other | Elective cardiac surgery |
Primary outcome
Sleep depth
Time frame: Up to 48 hours
Variance in sleep depth assessed as percent REM sleep of total sleep time (TST)
4 secondary outcomes
Odds Ratio Product-based sleep depth
Time frame: Up to 48 hours
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
Time frame: Up to 24 hours
Number of recorded patient visits
Time frame: 24 hours
Purpose of recorded patient visits
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Derived from this study: PubMed 42014445Skarke C, El Jamal N, Genuardi MV, Brooks TG, Mrcela A, Lahens NF, Cordoza M, Sarles S, Mbadugha A, Karunamuni DR, Gupta S, Bae CJ, Sehgal A, Cappola TP, Gutsche JT, Atluri P, Desai ND, Acker MA, Grant GR, Schwab RJ, Rosen IM, FitzGerald GA. Quantifying sleep wake rhythms in the hospital environment with digital technologies. NPJ Digit Med. 2026 Apr 21;9(1):479. doi: 10.1038/s41746-026-02639-w.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Skarke, MD principal investigator
University of Pennsylvania
Garret A FitzGerald, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Cardiovascular Diseases, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep depth (time frame: Up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05828680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.