Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators are performing this research study to understand the role of sleep disturbance on the incidence/severity of delirium after surgery. The investigators will study the brain using a polysomnography device (PSG), which records the brain's electrical activity during sleep.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium

NCT06052397

Delirium, Postoperative Cognitive Decline Dementia

RECRUITING

Role of REM Sleep Alterations in Post Operative Delirium After Cardiac Surgery

NCT02801318

Delirium Symptoms

UNKNOWN NA

Postoperative Delirium: EEG Markers of Sleep and Wakefulness

NCT03291626

Postoperative Delirium

COMPLETED

Relationship Between Perioperative Sleep Disturbance and Postoperative Delirium

NCT05457387

Postoperative Delirium

COMPLETED

Perioperative Electroencephalography Characteristics of Postoperative Delirium in Elderly

NCT03879850

Postoperative Delirium

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

During this study, PSG recordings will be collected and a sleep questionnaire will be administered to participants on the night before surgery in order to establish level of preexisting sleep disturbance. Delirium assessments will be conducted during the postoperative period. On postoperative days 0 and 1, blood will be collected for analysis. Further cognitive, quality of life and pain questionnaires will be administered perioperatively.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Delirium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MGH Surgery Patients

PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.

PSG

Intervention Type DEVICE

PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PSG

PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Over 60 years of age
* Inpatient and scheduled for surgical procedure at MGH

Exclusion Criteria

* Blindness, deafness or the inability to speak English
* Inability to provide informed consent

Objective Drop Criteria

* Post-operative intubation greater than 24 hours

Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes