RecruitingNAINTERVENTIONAL

Standardized Sleep Bundle for Cardiac Surgery Patients

This study is testing a special plan to help adults sleep better after heart surgery. Patients will be divided into two groups: one will receive regular care, and the other will get a "sleep bundle." This bundle includes items like a sleep mask, earplugs, and a noise machine, and sometimes specific sleep medicines if needed. Researchers want to see if this plan is easy to use and if patients can stick with it. They will track sleep using a wearable device and daily questionnaires. The results will help design a larger study in the future to understand the benefits of better sleep after heart surgery, such as reducing problems like confusion and shortening hospital stays.

At a glance

Status

Recruiting

Phase

Sponsor

Horizon Health Network

Enrolment target

Start

02 Mar 2026

Estimated completion

01 Jun 2026

Sleep

What is this study about?

When you have heart surgery, getting good sleep in the hospital can be tricky because of the lights, noises, and general disruption. This study wants to find out if giving patients a special "sleep plan" can help them rest better. The sleep plan includes simple things like a sleep mask to block light, earplugs to reduce noise, and a small machine to make soothing sounds. It also includes a careful approach to using sleep medicines if they are needed.

The main goal of this first study is to see if this sleep plan is practical. This means checking if patients are happy to join, if they can follow the steps, and if it's easy to collect information about their sleep. All of this information will help doctors decide if a bigger study should be done to prove that this sleep plan truly helps patients recover better and go home sooner.

Ultimately, by improving sleep, this research hopes to make a real difference in how well patients recover from heart surgery. Better sleep could lead to fewer problems like confusion after surgery and might even help patients get back home faster.

Key takeaways

This study aims to discover if a 'sleep bundle' helps heart surgery patients sleep better.
It tests practical ways to improve sleep like masks, earplugs, and noise machines.
บางคนก็จะได้ยาช่วยในการนอนหลับด้วย.
Participants will wear a Fitbit and complete daily sleep surveys during their hospital stay.
The results will help design a larger study to improve recovery for future patients.

Who may be eligible?

This study is looking for adults aged 19 and over, who are having planned, non-emergency heart surgery at the Saint John Regional Hospital. This means you can't be in the study if your surgery is an emergency.

There are also some health conditions that would prevent you from taking part. For example, if you have very poor kidney or liver function, sleep apnea (where you stop breathing in your sleep), restless leg syndrome, or a history of drug or alcohol problems. Also, if you regularly use certain strong sleep medications before your surgery, or have particular heart rhythm issues, or if you can't give your permission to be in the study, you wouldn’t be able to join.

Even if you are initially eligible, some things might happen right after your surgery that would mean you couldn't continue. For instance, if you need a specific artery in your wrist used for your surgery (as this affects wearing a sleep tracker), or if you need to be on a breathing machine or very sedated for a long time, or if you have serious complications after surgery like a stroke or major bleeding, you would then be withdrawn from the study before starting the main part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 19 years old or older?
Are you having planned heart surgery (not an emergency) at Saint John Regional Hospital?
Do you have severe kidney or liver problems?
Do you have sleep apnea, restless leg syndrome, or a history of dementia or substance use disorder?
Are you already taking certain strong sleep medications on a regular basis?
Are you able to give your permission to be part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly put into one of two groups, like flipping a coin. One group will receive the usual care after their heart surgery. The other group will receive the 'sleep bundle' in addition to usual care.

If you're in the sleep bundle group, you'll use a sleep mask, earplugs, and a noise machine each night. If you still have trouble sleeping, you might be offered a gentle sleep medication (melatonin), and if that's not enough, a slightly stronger one (trazodone or quetiapine) – all under guidance. Everyone in the study will wear a Fitbit device on their wrist at night to track their sleep. You'll also be asked to fill out a short daily questionnaire about how well you slept. The study will continue for the duration of your hospital stay after your surgery. There are no long-term follow-up visits after you leave the hospital specifically for this study.

Potential risks and benefits

Participating in research always has potential benefits and risks. A potential benefit of this study is that if you are in the sleep bundle group, you might experience improved sleep during your hospital stay, which could help your recovery. For all participants, your involvement helps researchers understand more about sleep after heart surgery, which could benefit future patients. The risks are generally low; wearing a Fitbit is safe, and the sleep aids and medications will be carefully managed by your medical team. You also have the right to withdraw from the study at any time, for any reason, without it affecting your care.

Locations (1)

Saint John Regional Hospital
Verified postcode
Saint John, Canada· Recruiting

Common questions

What is a 'sleep bundle'?

It's a collection of things designed to help you sleep, including a sleep mask, earplugs, a noise machine, and sometimes specific gentle sleep medications if needed.

Will I have to take sleeping pills?

Only if you're in the sleep bundle group and are still having trouble sleeping, and it will be a stepped approach starting with a milder option like melatonin, under medical guidance.

How long will I be in the study?

You'll be part of the study for the duration of your hospital stay after your heart surgery.

Will my regular doctors still take care of me?

Absolutely. Your medical team will continue to provide your usual post-surgery care, regardless of which study group you are in.

What information will the study collect about me?

The study will collect information about your sleep duration, how often you wake up, how you feel about your sleep, if you experience confusion after surgery, and how long you stay in the hospital.

How to find out more

Christopher W White, MD

christopher.white@horizonnb.ca 15066487782 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.