UMIN-ICDS Clinical Trial

Public title

A prospective observational study on the association between preoperative sleep quality, intraoperative EEG, and postoperative delirium

Acronym

PSQI-alphaPOD Study

Scientific Title

Association of Preoperative Sleep Quality (PSQI) With Intraoperative SedLine-Derived Frontal EEG Spectral Features and Mediation of Postoperative Delirium in Older Surgical Patients: A
Single-Center Prospective Observational Study

Scientific Title:Acronym

PSQI-alphaPOD

Region

Japan

Condition

Perioperative brain vulnerability (postoperative delirium) in patients aged 65 years or older undergoing elective surgery under general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To clarify the association between preoperative sleep quality (PSQI global score) and intraoperative frontal alpha power (8~12 Hz relative power) derived from SedLine EEG during the maintenance phase of general anesthesia. Further, to examine whether intraoperative alpha power mediates the relationship between PSQI and postoperative delirium (POD) through an exploratory mediation analysis. Secondary aims include assessing the association of PSQI components and other EEG spectral features (alpha-to-delta ratio, SEF95, burst suppression ratio, permutation entropy) with the primary exposure, as well as postoperative sleep quality (J RCSQ).

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Association between preoperative PSQI global score (continuous variable) and SedLine-derived frontal alpha power (8~12 Hz relative power, averaged across four channels) during the maintenance phase of general anesthesia.

Key secondary outcomes

1) Postoperative delirium (POD): assessed twice daily on POD1-3 using the 3D-CAM; POD is defined as positive if any assessment is positive across POD1-3.
2) Exploratory mediation analysis of PSQI -> frontal alpha power -> POD (Bootstrap 5,000 resamples, bias-corrected accelerated 95% confidence interval).
3) Associations between other EEG spectral features (alpha-to-delta ratio, SEF95, burst suppression ratio, permutation entropy) and PSQI.
4) Associations between individual PSQI components (C1 subjective sleep quality, C2 sleep latency, C3 sleep duration, C4 habitual sleep efficiency, C5 sleep disturbances, C6 use of
sleep medication, C7 daytime dysfunction) and alpha power (Bonferroni correction).
5) Comparison of EEG spectral features between POD and non-POD groups.
6) Postoperative sleep quality: J-RCSQ assessed every morning on POD1-3; the three-day mean is the analytic value. Independent predictors explored by multiple regression.
7) Independent contribution of PSQI to alpha power in partial correlation and multivariable linear regression adjusted for age, Mini-Cog, GDS-15, CFS, and aaMAC.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Aged 50 years or older at the time of informed consent.
2. Scheduled for elective surgery under general anesthesia with propofol induction and desflurane maintenance as part of routine clinical care.
3. Scheduled surgery duration of 90 minutes or more.
4. ASA-PS I, II, or III.
5. Able to complete preoperative assessments including PSQI, Mini-Cog, and GDS-15.
6. Written informed consent obtained after adequate explanation of the study.

Key exclusion criteria

1. Emergency surgery.
2. Neurosurgery.
3. Patients in whom frontal SedLine sensor placement is difficult (e.g., skin disorders, trauma).
4. Preoperative Mini-Cog score less than 3 (suspected cognitive impairment).
5. History of psychiatric disorders (schizophrenia, bipolar disorder).
6. History of cerebrovascular disease (cerebral infarction, cerebral hemorrhage, transient ischemic attack).
7. History of epilepsy.
8. Obstructive sleep apnea syndrome under ongoing CPAP therapy.
9. Cases in which intraoperative EEG recording required for the primary analysis cannot be obtained.
10. Other cases judged inappropriate by the principal investigator.

Target sample size

150

Name of lead principal investigator

1st name	Takuya
Middle name
Last name	Shiraishi

Organization

Hitachi General Hospital

Division name

Department of Anesthesiology

Zip code

317-0077

Address

2-1-1 Jonan-cho, Hitachi, Ibaraki 317-0077, Japan

TEL

0294-23-1111

Email

tshiraishi.1217@gmail.com

Name of contact person

1st name	Takuya
Middle name
Last name	Shiraishi

Organization

Hitachi General Hospital

Division name

Department of Anesthesiology

Zip code

317-0077

Address

2-1-1 Jonan-cho, Hitachi, Ibaraki 317-0077, Japan

TEL

0294-23-1111

Homepage URL

Email

tshiraishi.1217@gmail.com

Institute

Hitachi General Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hitachi General Hospital

Address

2-1-1 Jonan-cho, Hitachi, Ibaraki 317-0077, Japan

Tel

0294-23-1111

Email

tshiraishi.1217@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

04

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2016

Year

03

Month

15

Day

Date of IRB

Anticipated trial start date

2026

Year

04

Month

25

Day

Last follow-up date

2026

Year

12

Month

25

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a single-center prospective observational study and will be reported in accordance with the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology)
statement. Outcome assessors evaluating the primary outcome (postoperative delirium) are blinded to PSQI scores and
intraoperative EEG data. Variability in anesthetic management arising from routine clinical practice will be addressed by covariate adjustment and sensitivity analyses. This study is
exploratory and hypothesis-generating, aiming to prospectively examine the association between preoperative sleep quality and intraoperative EEG patterns. The findings are planned to be
presented at relevant national and international academic meetings in anesthesiology and perioperative medicine, and to be published in peer-reviewed journals.

Registered date

2026

Year

04

Month

19

Day

Last modified on

2026

Year

04

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070152