Tokyo, May 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061305) titled 'Pathophysiological clarification of nocturia in obstructive sleep apnea syndrome using a load-sensing sensor-equipped bed' on May 30.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Nara Medical University Hospital

Condition: Condition - Obstructive sleep apnea syndrome Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: 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 Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 01 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070146

Disclaimer: Curated by HT Syndication.