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Can a sleep mask and melatonin fix Post-Surgery sleeplessness?

NCT ID NCT07401836

Symptom relief Sponsor: Horizon Health Network Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether a standardized sleep bundle—including a sleep mask, ear plugs, a noise machine, and stepwise medications (melatonin, then trazodone if needed)—can improve sleep for adults recovering from cardiac surgery. Twenty participants will be randomly assigned to receive the bundle or usual care. The main goal is to see if the study procedures are feasible, not to prove the bundle works. Sleep will be tracked with a Fitbit and daily questionnaires.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Melatonin and trazodone (stepwise pharmacotherapy)
What this could lead to
If successful, this could lead to a simple, low-cost way to improve sleep and recovery for heart surgery patients.
What could go wrong
This is a very small pilot study (20 people) testing feasibility, not effectiveness. Results may not apply to all patients, and sleep aids may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients over 19 years old, undergoing non-emergent cardiac surgery with cardiopulmonary bypass at the Saint John Regional Hospital (SJRH). Exclusion Criteria: * 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. * 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).

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Conditions

The condition(s) this trial relates to.

sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sleep

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Saint John Regional Hospital

    RECRUITING

    Saint John, New Brunswick, E2L 4L2, Canada

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