UMIN-CTR Clinical Trial

Public title

Study on the Effects of Lung Resection on Patients' Sleep

Acronym

LSAStudy

Scientific Title

Study on the Effects of Lung Resection on Patients' Sleep

Scientific Title:Acronym

LSAStudy

Region

Japan

Condition

Lung tumor

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To prospectively evaluate the effects of lung resection surgery for pulmonary tumors on patients' sleep status, focusing on the incidence and severity of sleep apnea syndrome (SAS) and examining differences according to surgical procedures

Basic objectives2

Others

Basic objectives -Others

As secondary objectives, this study will explore the associations between postoperative sleep disturbances and clinical parameters, including arterial blood gas findings, pulmonary function tests, subjective sleepiness (Epworth Sleepiness Scale), quality of life (SF-36), and prognostic outcomes (recurrence, rehospitalization, mortality).

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. Apnea-hypopnea index (AHI).
2. Oxygen Desaturation Index (ODI).
3. Sleep efficiency
These outcomes will be assessed using simplified polysomnography (PSG) at baseline (preoperatively) and 1 year postoperatively.
For patients without a preoperative PSG evaluation, exploratory assessments will be conducted at one, two, three and five years postoperatively, provided that informed consent is obtained at these time points.

Key secondary outcomes

Arterial blood gas findings at baseline and, exploratorily, at 1 year postoperatively (only in patients with available data)
Pulmonary function tests (%VC, FEV1, etc.)
Epworth Sleepiness Scale for subjective sleepiness assessment
Duration of apnea episodes measured by simplified PSG
Quality of life assessment (e.g., SF-36, if available)
Prognostic information (recurrence, rehospitalization, mortality)

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

20

years-old

<

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Adult patients scheduled to undergo thoracic surgery for pulmonary tumors, with written informed consent

Key exclusion criteria

Patients already diagnosed with sleep apnea syndrome (SAS) preoperatively, or those judged unable to complete follow-up

Target sample size

50

Name of lead principal investigator

1st name	Gaku
Middle name
Last name	Yamaguchi

Organization

International University of Health and Welfare, Ichikawa Hospital

Division name

Thoracic Surgery

Zip code

272-0827

Address

6-1-14 Kounodai, Ichikawa-shi, Chiba, Japan

TEL

0473751111

Email

ugaku@hotmail.com

Name of contact person

1st name	Gaku
Middle name
Last name	Yamaguchi

Organization

International University of Health and Welfare, Ichikawa Hospital

Division name

Division of Thoracic Surgery

Zip code

2720827

Address

6-1-14 Kounodai, Ichikawa-shi, Chiba, Japan

TEL

0472751111

Homepage URL

Email

ugaku@hotmail.com

Institute

Internatinonal University of Health and Welfare

Institute

Department

Personal name

Organization

No external funding (self-funded study)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Chiba District Ethics Review Committee International University of Health and Welfare, Ichikawa Hospital

Address

6-1-14 Kounodai, Ichikawa-shi, Chiba, Japan

Tel

0473751111

Email

ugaku@hotmail.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

2025

Year

12

Month

08

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

2025

Year

11

Month

25

Day

Date of IRB

Anticipated trial start date

2025

Year

12

Month

08

Day

Last follow-up date

2029

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a single-center, prospective observational study conducted at the International University of Health and Welfare, Ichikawa Hospital. Adult patients undergoing thoracic surgery for pulmonary tumors will be evaluated using simplified polysomnography (PSG) before surgery and at 1 year postoperatively. For patients without preoperative PSG, exploratory assessments may be performed at 1-5 years postoperatively. Primary outcomes include AHI, ODI, and sleep efficiency, while secondary outcomes include arterial blood gas findings, pulmonary function tests, subjective sleepiness, quality of life, and prognostic information.

Registered date

2025

Year

12

Month

07

Day

Last modified on

2025

Year

12

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068630