SleepNCT07401836
Standardized Sleep Bundle for Cardiac Surgery Patients
A study testing Standardized Sleep Protocol and Usual Post Operative Care in people with Sleep, run by Horizon Health Network at 1 site in Canada.
Trial summary
The goal of this clinical trial is to evaluate the feasibility of using a standardized sleep bundle in adults undergoing cardiac surgery. The main questions it aims to answer are: 1. Can eligible participants be recruited and retained in the study? 2. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sleep
- What is being tested?
- Standardized Sleep Protocol and Usual Post Operative Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 2 Mar 2026to Jun 2026
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over 19 years old, undergoing non-emergent cardiac surgery with cardiopulmonary bypass at the Saint John Regional Hospital (SJRH).
Who cannot join
- Emergent surgery.
- Severe renal or hepatic impairment (creatinine clearance (CrCl) <30 mL/min, Chronic Kidney Disease (CKD) stage ≥4, cirrhosis, Alanine Transaminase (ALT) ≥ 3 × upper limit of normal (ULN)).
- Sleep apnea.
- Restless leg syndrome (RLS).
- Insomnia with chronic use of pharmacological sleep aids prior to admission (trazodone, benzodiazepines, zopiclone, mirtazapine, quetiapine, tricyclic antidepressants [nortriptyline, amitriptyline, doxepin]).
- Prior use of a monoamine oxidase inhibitor in the past 14 days.
Show all 14Show fewer
- Corrected QT Interval (QTc) > 500ms / history of prolonged QTc, Torsade de points or ventricular tachycardia.
- History of dementia, alcohol, or opioid use disorder.
- Documented or previous intolerance to melatonin, trazodone, or quetiapine. Unable to provide informed consent.
- Run-in Period Exclusions:
- After enrolment and before randomization, participants will be monitored for specific postoperative criteria. Those meeting any of the following criteria will be withdrawn prior to randomization.
- Radial artery harvest required (unable to place Fitbit device on the wrist contralateral to the arterial monitoring line).
- Prolonged intubation or sedation (> 48 hours) post-surgery.
- Major intra- or early postoperative complications (stroke, transient ischemic attach (TIA), major bleeding, need for mechanical/circulatory support, reoperation, open chest, pulmonary embolism, acute renal failure requiring dialysis or other major surgical complications that would inhibit ability to participate).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
About this study
Official title: Can a Standardized Sleep Bundle Reduce Sleep Disruption After Cardiac Surgery: A Pilot Randomized Controlled Trial
The goal of this clinical trial is to evaluate the feasibility of using a standardized sleep bundle in adults undergoing cardiac surgery. The main questions it aims to answer are:
- Can eligible participants be recruited and retained in the study?
- Can participants follow the study procedures, including using sleep aids and completing daily assessments?
- Can sleep and other clinical data be reliably collected during the hospital stay? Researchers will compare participants who receive the sleep bundle to participants who receive usual postoperative care.
Read more
Participants will:
- Use non-drug sleep aids, including a sleep mask, ear plugs, and a noise machine (sleep bundle group only).
- Take sleep medications if needed, following a stepwise protocol (sleep bundle group only).
- Complete daily sleep assessments using the Richards-Campbell Sleep Questionnaire (RCSQ).
- Wear a Fitbit device at night to track sleep.
- Follow usual postoperative care routines (control group)
The study will also collect and describe data on sleep duration, nighttime awakenings, subjective sleep quality, incidence of postoperative delirium, and hospital length of stay to inform the design of a future larger trial.
Read the detailed description
This study is a pilot randomized controlled trial designed to evaluate the feasibility and effects of a standardized sleep bundle on sleep quality in patients undergoing cardiac surgery. Adult patients scheduled for non-emergent cardiac surgery at the Saint John Regional Hospital (SJRH) will be screened for eligibility and enrolled after providing informed consent. Participants will be randomized to either usual postoperative care or the sleep bundle group.
The sleep bundle includes non-pharmacological interventions (sleep mask, ear plugs, nightly noise machine) and a stepwise pharmacological approach (melatonin, with trazodone or quetiapine added as needed). Sleep outcomes will be measured objectively using the Fitbit Inspire 3 device and subjectively using the Richards-Campbell Sleep Questionnaire (RCSQ). Feasibility will be assessed based on recruitment, retention, and adherence to the study protocol. Secondary outcomes include total sleep duration, nighttime awakenings, subjective sleep quality, incidence of postoperative delirium, and hospital length of stay.
All study procedures and daily assessments will be conducted by trained research personnel, with data analysis performed by a team member blinded to group allocation. This pilot study will inform the design of a future larger-scale trial.
- Conditions
- Sleep
- Being tested
- Standardized Sleep Protocol, Usual Post Operative Care
- Keywords
- cardiovascular surgery, sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Sleep ProtocolOther
Non-Pharmacological Sleep Aids
- All participants will be encouraged to wear a sleep mask and ear plugs nightly. In addition, a noise machine will be provided each night, the content and volume of which will be decided by the patient.
- Stepwise Pharmacotherapy Approach
Step 1: Melatonin
- Melatonin 6 mg orally at bedtime will be initiated for all participants in the sleep bundle group.
Step 2: Adjunctive Therapy (Trazodone)
- If the participants daily RCSQ score is below 63.4 or the participant reports inadequate sleep despite melatonin, trazodone will be scheduled orally at bedtime.
- Trazodone will start at 25 mg and may be increased in 25 mg increments up to 100 mg orally at bedtime, based on participant response and tolerability.
Step 3: Escalation for Delirium (Quetiapine)
- If the participant has documented postoperative delirium, quetiapine 12.5 mg immediate release oral tablet will be scheduled at bedtime.
- Dose may be increased in 12.5 mg increments up to 100 mg as cli
Usual Post Operative CareOther
Standard postoperative care without the structured sleep bundle. This includes routine clinical management of sleep without non-pharmacological interventions or protocolized pharmacological sleep aid. Any sleep medications administered will be at the discretion of the care team, without a standardized approach, reflecting standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Bundle Group | Experimental | Participants in this group will receive a standardized sleep management protocol combining non-pharmacological interventions and stepwise pharmacotherapy. Receives: Other: Standardized Sleep Protocol |
| Usual Post Operative Care | Active comparator | Participants randomized to the control group will receive usual postoperative care. Receives: Other: Usual Post Operative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Proportion of eligible patients who consent to participate in the study. Recruitment success is defined as greater than 50% of eligible patients enrolled. Reported as a percentage.
Measured: From first participant enrollment until last participant enrolled (approximately 8 weeks)
Retention Rate
Proportion of participants who complete the study. Retention success is defined as greater than 80% of participants completing the study. Reported as a percentage.
Measured: From enrollment until hospital discharge for each participant ( approximately 5 days)
Protocol Adherence
Proportion of daily study assessments completed by participants. Reported as a percentage of completed assessments out of total expected assessments.
Measured: Daily from Day 1 of enrollment through hospital discharge (approximately 5 days)
Fitbit Adherence
Number of nights the Fitbit is worn ( minimum 3 scheduled nights). Reported as count and percentage of participants meeting adherence criteria.
Measured: Each night from Day 1 of enrollment through hospital discharge (approximately 5 days)
Time to Reach Target Sample Size
Number of days required to enroll the target sample size of 20 participants. Reported in days.
Measured: From first participant enrolment to enrolment of the 20th participant ( approximately 8 weeks)
Secondary outcomes (5)
Total Sleep Duration
Objective sleep duration will be measured using the Fitbit Inspire 3 device, worn on the wrist contralateral to the radial arterial line. The device records total sleep time nightly between 9:00 PM and 9:00 AM. Data will be summarized using daily means, standard deviations, medians, and interquartile ranges.
Measured: Nightly from postoperative day 1 through postoperative day 5 or hospital discharge, whichever occurs first.
Nighttime Awakenings
Objective nighttime awakenings will be measured using the Fitbit Inspire 3 device, recorded nightly between 9:00 PM and 9:00 AM. Daily counts of awakenings will be summarized using means, standard deviations, medians, and interquartile ranges.
Measured: Nightly from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first
Subjective Sleep Quality
Subjective sleep quality will be assessed each morning using the Richards-Campbell Sleep Questionnaire (RCSQ), a validated 0-100 mm visual analog scale evaluating sleep depth, latency, awakenings, efficiency, and overall quality. Scores will be averaged across the five domains. Daily scores will be summarized using descriptive statistics.
Measured: Each morning from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first
Incidence of Postoperative Delirium
Incidence of delirium will be recorded based on daily assessments documented by the care team in patient charts. Counts and percentages of participants experiencing delirium will be reported.
Measured: Daily from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first.
Hospital Length of Stay
Length of stay will be recorded in days from the date of surgery to the date of discharge, as documented in the patient's medical record. Data will be summarized using descriptive statistics.
Measured: From day of surgery (postoperative day 0) through postoperative day 5 or until hospital discharge, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start2 Mar 2026
- Primary completion29 May 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective pilot randomized controlled study with a parallel group design comparing a sleep bundle intervention to usual postoperative care, with feasibility as the primary outcome.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horizon Health Network
- Sponsor type
- University, hospital or other
- Collaborators
- New Brunswick Heart Centre
- Responsible party
- Principal investigator, Caroline.Fitzpatrick, Horizon Health Network
- Investigators
- Caroline E Fitzpatrick, Principal investigator, Horizon Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401836
- Sponsor's protocol ID
- 102398
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data has not yet been determined. Plans for data sharing will be considered once the feasibility and outcomes of the pilot study are evaluated.
Publications
Elliott R, Axelin A, Richards KC, Vahlberg T, Ritmala-Castren M. Sensitivity and specificity of proposed Richards-Campbell Sleep Questionnaire cut-off scores for good quality sleep during an ICU stay. J Clin Nurs. 2023 Jun;32(11-12):2700-2708. doi: 10.1111/jocn.16348. Epub 2022 May 15.
PubMed 35570380Haghayegh S, Khoshnevis S, Smolensky MH, Diller KR, Castriotta RJ. Accuracy of Wristband Fitbit Models in Assessing Sleep: Systematic Review and Meta-Analysis. J Med Internet Res. 2019 Nov 28;21(11):e16273. doi: 10.2196/16273.
PubMed 31778122Soh PQP, Wong WHT, Roy T, Tam WWS. Effectiveness of non-pharmacological interventions in improving sleep quality after cardiac surgery: A systematic review and meta-analysis. J Clin Nurs. 2024 Jun;33(6):2084-2098. doi: 10.1111/jocn.17115. Epub 2024 Mar 13.
PubMed 38477050Mahran GS, Leach MJ, Abbas MS, Abbas AM, Ghoneim AM. Effect of Eye Masks on Pain and Sleep Quality in Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial. Crit Care Nurse. 2020 Feb 1;40(1):27-35. doi: 10.4037/ccn2020709.
PubMed 32006033Liao WC, Huang CY, Huang TY, Hwang SL. A systematic review of sleep patterns and factors that disturb sleep after heart surgery. J Nurs Res. 2011 Dec;19(4):275-88. doi: 10.1097/JNR.0b013e318236cf68.
PubMed 22089653Simeone S, Pucciarelli G, Perrone M, Teresa R, Gargiulo G, Guillari A, Castellano G, Tommaso LD, Niola M, Iannelli G. Delirium in ICU patients following cardiac surgery: An observational study. J Clin Nurs. 2018 May;27(9-10):1994-2002. doi: 10.1111/jocn.14324. Epub 2018 Apr 25.
PubMed 29493837Zhang WY, Wu WL, Gu JJ, Sun Y, Ye XF, Qiu WJ, Su CQ, Zhang SQ, Ye WQ. Risk factors for postoperative delirium in patients after coronary artery bypass grafting: A prospective cohort study. J Crit Care. 2015 Jun;30(3):606-12. doi: 10.1016/j.jcrc.2015.02.003. Epub 2015 Feb 7.
PubMed 25708120Caruana N, McKinley S, Elliott R, Gholizadeh L. Sleep Quality During and After Cardiothoracic Intensive Care and Psychological Health During Recovery. J Cardiovasc Nurs. 2018 Jul/Aug;33(4):E40-E49. doi: 10.1097/JCN.0000000000000499.
PubMed 29771744
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Standardized Sleep Bundle Reduce Sleep Disruption After Cardiac Surgery: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07401836
- Acronym / sponsor ID
- 102398
- Conditions
- Sleep
- Keywords
- cardiovascular surgery, sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Horizon Health NetworkUniversity, hospital or other
- Collaborators
- New Brunswick Heart Centre
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 29 May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 Feb 2026 (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.
The goal of this clinical trial is to evaluate the feasibility of using a standardized sleep bundle in adults undergoing cardiac surgery. The main questions it aims to answer are:
- Can eligible participants be recruited and retained in the study?
- Can participants follow the study procedures, including using sleep aids and completing daily assessments?
- Can sleep and other clinical data be reliably collected during the hospital stay? Researchers will compare participants who receive the sleep bundle to participants who receive usual postoperative care.
Participants will:
- Use non-drug sleep aids, including a sleep mask, ear plugs, and a noise machine (sleep bundle group only).
- Take sleep medications if needed, following a stepwise protocol (sleep bundle group only).
- Complete daily sleep assessments using the Richards-Campbell Sleep Questionnaire (RCSQ).
- Wear a Fitbit device at night to track sleep.
- Follow usual postoperative care routines (control group)
The study will also collect and describe data on sleep duration, nighttime awakenings, subjective sleep quality, incidence of postoperative delirium, and hospital length of stay to inform the design of a future larger trial.
Detailed description
This study is a pilot randomized controlled trial designed to evaluate the feasibility and effects of a standardized sleep bundle on sleep quality in patients undergoing cardiac surgery. Adult patients scheduled for non-emergent cardiac surgery at the Saint John Regional Hospital (SJRH) will be screened for eligibility and enrolled after providing informed consent. Participants will be randomized to either usual postoperative care or the sleep bundle group.
The sleep bundle includes non-pharmacological interventions (sleep mask, ear plugs, nightly noise machine) and a stepwise pharmacological approach (melatonin, with trazodone or quetiapine added as needed). Sleep outcomes will be measured objectively using the Fitbit Inspire 3 device and subjectively using the Richards-Campbell Sleep Questionnaire (RCSQ). Feasibility will be assessed based on recruitment, retention, and adherence to the study protocol. Secondary outcomes include total sleep duration, nighttime awakenings, subjective sleep quality, incidence of postoperative delirium, and hospital length of stay.
All study procedures and daily assessments will be conducted by trained research personnel, with data analysis performed by a team member blinded to group allocation. This pilot study will inform the design of a future larger-scale trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective pilot randomized controlled study with a parallel group design comparing a sleep bundle intervention to usual postoperative care, with feasibility as the primary outcome.
| Arm | Type | Receives |
|---|---|---|
| Sleep Bundle Group | Experimental | Other: Standardized Sleep ProtocolParticipants in this group will receive a standardized sleep management protocol combining non-pharmacological interventions and stepwise pharmacotherapy. |
| Usual Post Operative Care | Active comparator | Other: Usual Post Operative CareParticipants randomized to the control group will receive usual postoperative care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients over 19 years old, undergoing non-emergent cardiac surgery with cardiopulmonary bypass at the Saint John Regional Hospital (SJRH).
Key exclusion criteria (14 listed)
- Emergent surgery.
- Severe renal or hepatic impairment (creatinine clearance (CrCl) <30 mL/min, Chronic Kidney Disease (CKD) stage ≥4, cirrhosis, Alanine Transaminase (ALT) ≥ 3 × upper limit of normal (ULN)).
- Sleep apnea.
- Restless leg syndrome (RLS).
- Insomnia with chronic use of pharmacological sleep aids prior to admission (trazodone, benzodiazepines, zopiclone, mirtazapine, quetiapine, tricyclic antidepressants [nortriptyline, amitriptyline, doxepin]).
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 |
|---|---|---|
| Standardized Sleep ProtocolNon-Pharmacological Sleep Aids * All participants will be encouraged to wear a sleep mask and ear plugs nightly. In addition, a noise machine will be provided each night, the content and volume of which will be decided by the patient. * Stepwise Pharmacotherapy Approach Step 1: Melatonin - Melatonin 6 mg orally at bedtime will be initiated for all participants in the sleep bundle group. Step 2: Adjunctive Therapy (Trazodone) * If the participants daily RCSQ score is below 63.4 or the participant reports inadequate sleep despite melatonin, trazodone will be scheduled orally at bedtime. * Trazodone will start at 25 mg and may be increased in 25 mg increments up to 100 mg orally at bedtime, based on participant response and tolerability. Step 3: Escalation for Delirium (Quetiapine) * If the participant has documented postoperative delirium, quetiapine 12.5 mg immediate release oral tablet will be scheduled at bedtime. * Dose may be increased in 12.5 mg increments up to 100 mg as cli | Other | Sleep Bundle Group |
| Usual Post Operative CareStandard postoperative care without the structured sleep bundle. This includes routine clinical management of sleep without non-pharmacological interventions or protocolized pharmacological sleep aid. Any sleep medications administered will be at the discretion of the care team, without a standardized approach, reflecting standard practice. | Other | Usual Post Operative Care |
Primary outcome
Recruitment Rate
Time frame: From first participant enrollment until last participant enrolled (approximately 8 weeks)
Proportion of eligible patients who consent to participate in the study. Recruitment success is defined as greater than 50% of eligible patients enrolled. Reported as a percentage.
Retention Rate
Time frame: From enrollment until hospital discharge for each participant ( approximately 5 days)
Proportion of participants who complete the study. Retention success is defined as greater than 80% of participants completing the study. Reported as a percentage.
Protocol Adherence
Time frame: Daily from Day 1 of enrollment through hospital discharge (approximately 5 days)
Proportion of daily study assessments completed by participants. Reported as a percentage of completed assessments out of total expected assessments.
Fitbit Adherence
Time frame: Each night from Day 1 of enrollment through hospital discharge (approximately 5 days)
Number of nights the Fitbit is worn ( minimum 3 scheduled nights). Reported as count and percentage of participants meeting adherence criteria.
Time to Reach Target Sample Size
Time frame: From first participant enrolment to enrolment of the 20th participant ( approximately 8 weeks)
Number of days required to enroll the target sample size of 20 participants. Reported in days.
5 secondary outcomes
Total Sleep Duration
Time frame: Nightly from postoperative day 1 through postoperative day 5 or hospital discharge, whichever occurs first.
Nighttime Awakenings
Time frame: Nightly from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first
Subjective Sleep Quality
Time frame: Each morning from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first
Incidence of Postoperative Delirium
Time frame: Daily from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first.
Hospital Length of Stay
Time frame: From day of surgery (postoperative day 0) through postoperative day 5 or until hospital discharge, whichever occurs first
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 30 Mar 2026.
- Background: PubMed 35570380Elliott R, Axelin A, Richards KC, Vahlberg T, Ritmala-Castren M. Sensitivity and specificity of proposed Richards-Campbell Sleep Questionnaire cut-off scores for good quality sleep during an ICU stay. J Clin Nurs. 2023 Jun;32(11-12):2700-2708. doi: 10.1111/jocn.16348. Epub 2022 May 15.
- Background: PubMed 31778122Haghayegh S, Khoshnevis S, Smolensky MH, Diller KR, Castriotta RJ. Accuracy of Wristband Fitbit Models in Assessing Sleep: Systematic Review and Meta-Analysis. J Med Internet Res. 2019 Nov 28;21(11):e16273. doi: 10.2196/16273.
- Background: PubMed 38477050Soh PQP, Wong WHT, Roy T, Tam WWS. Effectiveness of non-pharmacological interventions in improving sleep quality after cardiac surgery: A systematic review and meta-analysis. J Clin Nurs. 2024 Jun;33(6):2084-2098. doi: 10.1111/jocn.17115. Epub 2024 Mar 13.
- Background: PubMed 32006033Mahran GS, Leach MJ, Abbas MS, Abbas AM, Ghoneim AM. Effect of Eye Masks on Pain and Sleep Quality in Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial. Crit Care Nurse. 2020 Feb 1;40(1):27-35. doi: 10.4037/ccn2020709.
- Background: PubMed 22089653Liao WC, Huang CY, Huang TY, Hwang SL. A systematic review of sleep patterns and factors that disturb sleep after heart surgery. J Nurs Res. 2011 Dec;19(4):275-88. doi: 10.1097/JNR.0b013e318236cf68.
- Background: PubMed 29493837Simeone S, Pucciarelli G, Perrone M, Teresa R, Gargiulo G, Guillari A, Castellano G, Tommaso LD, Niola M, Iannelli G. Delirium in ICU patients following cardiac surgery: An observational study. J Clin Nurs. 2018 May;27(9-10):1994-2002. doi: 10.1111/jocn.14324. Epub 2018 Apr 25.
- Background: PubMed 25708120Zhang WY, Wu WL, Gu JJ, Sun Y, Ye XF, Qiu WJ, Su CQ, Zhang SQ, Ye WQ. Risk factors for postoperative delirium in patients after coronary artery bypass grafting: A prospective cohort study. J Crit Care. 2015 Jun;30(3):606-12. doi: 10.1016/j.jcrc.2015.02.003. Epub 2015 Feb 7.
- Background: PubMed 29771744Caruana N, McKinley S, Elliott R, Gholizadeh L. Sleep Quality During and After Cardiothoracic Intensive Care and Psychological Health During Recovery. J Cardiovasc Nurs. 2018 Jul/Aug;33(4):E40-E49. doi: 10.1097/JCN.0000000000000499.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data has not yet been determined. Plans for data sharing will be considered once the feasibility and outcomes of the pilot study are evaluated.
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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.
Caroline E Fitzpatrick principal investigator
Horizon Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Sleep Protocol and Usual Post Operative Care in people with Sleep, run by Horizon Health Network at 1 site in Canada.
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 1 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 30 Mar 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 Canada. 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?
Contact Christopher W White, MD (15066487782, Christopher.White@HorizonNB.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: From first participant enrollment until last participant enrolled (approximately 8 weeks)). The study lists 5 primary outcomes in all. 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 NCT07401836, which also lists 8 linked publications.
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 30 Mar 2026.