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Your sleep watch could predict Post-Surgery confusion

NCT ID NCT06052397

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study looks at whether sleep patterns in the two weeks before major orthopedic surgery can help predict delirium (sudden confusion) after the operation. Researchers will ask 150 older adults (70+) to wear a watch that tracks sleep and to give blood samples. The goal is to find sleep-related biomarkers that could identify those at higher risk for postoperative delirium and cognitive decline.

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.

Participants

About 150 people

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

Started

Sep 2023

Expected to finish

Sep 2027

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.

Who is studied

The Targeted/Planned enrollment for the proposed clinical study is consistent with the ethnic and racial composition of Suffolk County, MA. Please see below. American Indian and Alaska Native - 0.7 Native Hawaiian and Other Pacific Islander - 0.2 Asian - 9.3 Black, not Hispanic or Latino - 24.3 White, not Hispanic or Latino - 45.2 Hispanic or Latino - 23.3 Two or more races - 3.7 Female - 51.7

Ages

70 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: * Age \>= 70 years old * Scheduled to undergo major orthopedic surgery * Expected postoperative recovery of more than 24 hours as an inpatient Exclusion Criteria: * Cognitive impairment leading to inability to consent * Patients with limited mobility or inability to wear an actigraphy watch * Patients with infection at the site of actigraphy watch, allergies to materials of watch * Patients with \> two days in the ICU during the month prior to surgery * Renal or liver failure * Severe neurocognitive damage or history of psychiatric illness * Blindness or deafness * Patients who are non-English speaking

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction delirium dementia Emergence Delirium

As listed by the trial registrant

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

Cognitive decline Delirium, postoperative Dementia

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

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

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