UMIN-ICDS Clinical Trial

Public title

Pathophysiological clarification of nocturia in obstructive sleep apnea syndrome using a load-sensing sensor-equipped bed

Acronym

Load Sensor-Based Differential Diagnosis of OSAS Nocturia

Scientific Title

A prospective observational study on the differential diagnosis of nocturia and prediction of CPAP treatment response in obstructive sleep apnea syndrome using a load-sensing bed

Scientific Title:Acronym

OSAS Nocturia Differentiation by Load Sensor

Region

Japan

Condition

Obstructive sleep apnea syndrome

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The primary objective of this study is to validate a non-invasive sleep monitoring technology using a bed equipped with load-sensing sensors, and to analyze the pathophysiology of nocturia in patients with obstructive sleep apnea (OSA) from the perspective of "voided volume (changes in body weight)," thereby constructing a personalized treatment prediction model.
 
Specifically, this study has the following two objectives:
 
1. Validation of sleep assessment using the load-sensing sensor
Using standard overnight polysomnography (PSG) as a reference, the accuracy of the sleep stages and sleep efficiency obtained from the load-sensing sensor will be verified. This will clarify the utility of evaluating sleep architecture in a natural sleep environment free from physical constraints.
 
2. Differentiation and treatment prediction of nocturia: "OSA-induced" versus "BPH/OAB-induced"
This study aims to elucidate the pathophysiology of nocturia, a common comorbidity in OSA patients, using precise body weight measurements (load differences before and after voiding) obtained via the load sensor.

Establishment of a differential diagnostic protocol: Focusing on the weight per void (voided volume), we will evaluate a method to non-invasively distinguish between "polyuric OSA-induced urination" and "low-volume, high-frequency urination induced by benign prostatic hyperplasia (BPH) or overactive bladder (OAB)."

Prediction of CPAP treatment efficacy: Based on the hypothesis that voiding events caused by BPH/OAB involve minimal changes in body weight, we will predict which nocturia events will "resolve" and which will "persist (residual nocturia)" following CPAP initiation, prior to the actual treatment.

Verification of the therapeutic mechanism: During CPAP-titrated PSG, we will compare the load changes of voiding events that resolve upon the elimination of apneas with those that persist (attributable to BPH, etc.) to validate the accuracy of the prediction model.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Concordance between the predicted and actual number of residual voiding events under CPAP therapy

Key secondary outcomes

Concordance of sleep stages and sleep efficiency between the load sensor and PSG

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

CPAP therapy will be initiated as a therapeutic intervention for obstructive sleep apnea accompanied by nocturia. After approximately four months of CPAP treatment, therapeutic efficacy will be evaluated using PSG.

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

40

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion Criteria

Suspected OSA: Patients suspected of having OSA due to symptoms such as snoring, daytime sleepiness, or witnessed apneas, and who are deemed eligible for a diagnostic overnight polysomnography (PSG).

Subjective symptoms of nocturia: Patients who report waking up one or more times to void between going to bed and waking up, within the past month.

Age: 40 years of age or older.

Sex: Any (however, sex differences will be accounted for in the analysis).

Informed consent: Patients who have received a sufficient explanation regarding the purpose and contents of this study and have voluntarily provided written informed consent.

Key exclusion criteria

Exclusion Criteria

Comorbidities affecting urine volume or voiding function:

Poorly controlled diabetes mellitus (due to the effect of polyuria from osmotic diuresis).

Severe heart failure (NYHA class III or higher) or chronic renal failure (as these constitute alternative causes of nocturnal polyuria).

Active urinary tract infections (e.g., cystitis) or bladder cancer.

Influence of medications:

Patients currently taking diuretics, or those scheduled to initiate or change the dose of diuretics during the study period.

Other conditions severely disrupting sleep:

Patients with severe insomnia, restless legs syndrome (RLS), periodic limb movement disorder (PLMD), or similar conditions, in whom load sensor analysis is expected to be difficult due to excessive body movements.

Physical limitations:

Patients who have difficulty walking or transferring to the toilet independently (to exclude load changes caused by caregiver assistance).

Patients whose body weight falls outside the measurable range of the sensor (e.g., under 40 kg or over 150 kg).

Others:

Patients deemed inappropriate for participation by the investigator.

Target sample size

120

Name of lead principal investigator

1st name	Ryosuke
Middle name
Last name	Kataoka

Organization

Nara Medical University Hospital

Division name

Department of Respiratory Medicine

Zip code

634-8522

Address

840 Shijo-cho, Kashihara, Nara

TEL

0744-22-3051

Email

ktok22@naramed-u.ac.jp

Name of contact person

1st name	Ryosuke
Middle name
Last name	Kataoka

Organization

Nara Medical University Hospital

Division name

Department of Respiratory Medicine

Zip code

634-8522

Address

840 Shijo-cho, Kashihara, Nara

TEL

0744-22-3051

Homepage URL

Email

ktok22@naramed-u.ac.jp

Institute

Nara Medical University Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nara Medical University Hospital

Address

840 Shijo-cho, Kashihara, Nara

Tel

0744-22-3051

Email

ktok22@naramed-u.ac.jp

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

05

Month

30

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

2026

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2026

Year

06

Month

01

Day

Last follow-up date

2027

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

04

Month

18

Day

Last modified on

2026

Year

04

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070146