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

An observational study of Delirium, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 60 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Delirium
What is being tested?: PSG
Type of treatment: Medical device
How many people: 38 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2018to 1 Sep 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Inpatients over the age of 60 scheduled for a surgical procedure at MGH

Who may be able to join

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

Who cannot join

Blindness, deafness or the inability to speak English
Inability to provide informed consent
Objective Drop Criteria
Post-operative intubation greater than 24 hours

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Read the detailed description

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: Delirium
Being tested: PSG
Medical subject headings: Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03498560
Study group	Role	What they receive
MGH Surgery Patients		PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH. Receives: Device: PSG

What is being measured

The primary outcome is the main question the study is designed to answer.

Association Between Sleep and POD
Duration of sleep in delirious vs non-delirious patients
Measured: Night before surgery, approximately 13 hours

Secondary outcomes (1)

Burst Suppression Ratio
Burst suppression ratio during cardiopulmonary bypass. EEG recordings from the operating room were collected and analyzed for burst suppression.
Measured: Length of surgery (2-12 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20181 Sep 2019

First posted13 Apr 2018
Study start1 Nov 2018
Primary completion1 Jul 2019
Study completion1 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DeliriumStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03498560
Sponsor's protocol ID: 2018P000480
Status last verified: Mar 2022
First submitted: 5 Apr 2018
Last updated: 31 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Ibala R, Mekonnen J, Gitlin J, Hahm EY, Ethridge BR, Colon KM, Marota S, Ortega C, Pedemonte JC, Cobanaj M, Chamadia S, Qu J, Gao L, Barbieri R, Akeju O. A polysomnography study examining the association between sleep and postoperative delirium in older hospitalized cardiac surgical patients. J Sleep Res. 2021 Oct;30(5):e13322. doi: 10.1111/jsr.13322. Epub 2021 Mar 24.
PubMed 33759264

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)

All Delirium trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium
ClinicalTrials.gov ID: NCT03498560
Acronym / sponsor ID: 2018P000480
Conditions: Delirium
Study type: Observational
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 1 Nov 2018 (actual)
Primary completion: 1 Jul 2019 (actual)
Study completion: 1 Sep 2019 (actual)
First posted: 13 Apr 2018 (actual)
Results: Posted 4 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
MGH Surgery Patients	–	Device: PSGPSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.

Who may qualify

Ages: 60 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Inpatients over the age of 60 scheduled for a surgical procedure at MGH

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

Blindness, deafness or the inability to speak English
Inability to provide informed consent
Objective Drop Criteria
Post-operative intubation greater than 24 hours

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
PSGPSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.	Device	MGH Surgery Patients

Primary outcome

Association Between Sleep and POD
Time frame: Night before surgery, approximately 13 hours
Duration of sleep in delirious vs non-delirious patients

1 secondary outcome

Burst Suppression Ratio
Time frame: Length of surgery (2-12 hours)

Results and safety

Results posted to the registry on 4 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MGH Surgery Patients	38	17

Primary outcome: Association Between Sleep and POD

Time frame: Night before surgery, approximately 13 hours. Median (Inter-Quartile Range). Unit: Minutes

Measure	MGH Surgery Patients n = 16
Non Delirium	278.5 (239.5 to 315.5)
Delirium	313.5 (271.3 to 352.5)

Population analysed: Many of the PSG data samples that were collected the night of surgery were not interpretable and poor quality.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected form the time the patient was enrolled to the completion of the follow-up assessment at 30 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MGH Surgery Patients	0 of 38 (0%)	0 of 38 (0%)	1 of 38

Limitations and caveats (from the sponsor): The quality of many of the PSG recordings was poor and not interpretable. After patients enrolled, many withdrew at the time the PSG was to be placed. So, sleep was recorded for fewer patients. Blood was not analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33759264Ibala R, Mekonnen J, Gitlin J, Hahm EY, Ethridge BR, Colon KM, Marota S, Ortega C, Pedemonte JC, Cobanaj M, Chamadia S, Qu J, Gao L, Barbieri R, Akeju O. A polysomnography study examining the association between sleep and postoperative delirium in older hospitalized cardiac surgical patients. J Sleep Res. 2021 Oct;30(5):e13322. doi: 10.1111/jsr.13322. Epub 2021 Mar 24.

Related trials for Delirium

Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Delirium, run by Massachusetts General Hospital at 1 site in United States.

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 2 inclusion and 4 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: finished, as of the sponsor's last update on 31 Mar 2022. 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 United States. 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?

Yes. Results are posted in the registry (first posted 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association Between Sleep and POD (time frame: Night before surgery, approximately 13 hours). 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 NCT03498560, which also lists 1 linked publication.

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 31 Mar 2022.