Evaluation of the Diagnostic Capacity of a Smart Mattress Versus Conventional Polysomnography
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of the smart mattress for detecting sleep apnea.
研究概览
简要总结
This project aims to develop and evaluate an innovative, non-invasive diagnostic system based on a smart mattress for detecting obstructive sleep apnea (OSA), as well as assessing overall sleep quality and identifying periodic limb movements. The main goal is to improve the accuracy of sleep apnea diagnosis while providing a less invasive solution suitable for home use, ultimately enhancing patients' quality of life.
A descriptive, observational, prospective study will be conducted to analyze data obtained from diagnostic polysomnographies performed at the Sleep Unit of San Pedro Hospital between November 17, 2026, and March 1, 2028. Patients will use the smart mattress, and its measurements will be compared with polysomnography results. This comparison will allow for the optimization of the mattress's artificial intelligence, training it to accurately recognize respiratory patterns and sleep-related events, including positional apneas and periodic limb movements.
Key technical objectives include:
Determining the sensitivity, specificity, and predictive values of the mattress in detecting apneas, hypopneas, and limb movements compared to polysomnography.
Evaluating the agreement between the mattress and polysomnography for sleep variables such as total sleep time, sleep efficiency, sleep stages, micro-arousals, and patient position.
Assessing whether measurement accuracy varies by sleeping position or age group (adults vs. children).
Measuring subjective sleep quality using the Groningen Sleep Quality Scale (GSQS-8).
Performing a descriptive analysis of patient demographics.
Hypotheses:
The smart mattress will detect obstructive sleep apnea, sleep quality, and periodic limb movements with accuracy comparable to polysomnography.
The system will provide a reliable, non-invasive, home-friendly diagnostic method.
Measurements of the apnea-hypopnea index (AHI) and limb movements will show high sensitivity, specificity, and predictive values, both overall and according to OSA severity.
There will be good agreement between mattress measurements and polysomnography for most sleep variables.
Accuracy may vary depending on the patient's sleeping position.
Measurements will correlate well across adults and pediatric patients.
Subjective sleep quality scores (GSQS-8) will be consistent with objective mattress data.
This project seeks to develop a more accurate, accessible, and non-invasive diagnostic system for OSA, combining advanced technology with ease of home use. By training the mattress's AI to recognize sleep patterns and events, it aims to optimize the detection of positional apneas, providing patients with better monitoring, early intervention, and improved quality of life.
详细描述
This project corresponds to a descriptive, observational, and prospective study whose objective is to validate the functioning, accuracy, and clinical applicability of an intelligent mattress designed for the non-invasive detection of sleep-related respiratory disturbances, in comparison with level I polysomnography (the gold standard for OSA diagnosis). This phase constitutes the first stage of the global project aimed at the diagnosis and treatment of obstructive sleep apnea (OSA) through advanced monitoring and postural-adaptation technologies.
During the period between November 17, 2026, and March 1, 2028, all polysomnographies performed in the Sleep Unit of Hospital San Pedro will be incorporated into a systematic registry together with the data simultaneously generated by the intelligent mattress. The aim is to determine the level of agreement between both systems, validate the diagnostic utility of the mattress, and generate the database required for the subsequent development of artificial intelligence algorithms for the automatic identification of respiratory events and sleep stages.
- REGISTRY PROCEDURES AND DATA QUALITY
The centralized registry will include all polysomnographic studies performed with Natus equipment, stored on its internal server, and the parallel recordings from the intelligent mattress. The registry structure will be designed to ensure data traceability, integrity, and quality, with specific procedures for technical validation, clinical verification, and coherence control.
1.1 Quality Assurance Plan
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Polysomnographies performed at San Pedro Hospital between November 17, 2026, and March 1,
- •Polysomnographies of patients under 16 years of age and polysomnographies performed at San Pedro Hospital on patients over 16 years of age (as separate study groups).
排除标准
- •Poor technical quality of the polysomnography.
- •Patients with >50% central apneas or presence of Cheyne-Stokes respiration (CSResp).
- •Lack of polysomnography analysis and/or mattress data.
研究组 & 干预措施
People with suspected obstructive sleep apnea (OSA)
Patients will undergo the PSG on a smart mattress, which will allow simultaneous recording of:
Standard PSG data, considered the gold standard in sleep studies.
Data generated by the smart mattress, including signals and metrics related to movement, breathing, and other physiological parameters detectable by the device.
The data obtained from the mattress will be compared with the PSG results in order to:
Validate the mattress's ability to detect respiratory patterns and events during sleep.
Optimize and train the mattress's artificial intelligence system, improving its diagnostic accuracy in identifying respiratory events and other sleep disturbances.
干预措施: Integrated polysomnographic assessment with smart mattress. (Device)
结局指标
主要结局
Diagnostic accuracy of the smart mattress for detecting sleep apnea.
时间窗: Night of simultaneous PSG and mattress recording (one night per participant).
Measured by: Sensitivity Specificity Predictive values (PPV/NPV) Compared with polysomnography (PSG).
次要结局
- Total sleep time(Night of simultaneous PSG and mattress recording (one night per participant).)
- Diagnostic accuracy according to sleep position.(Night of simultaneous PSG and mattress recording (one night per participant).)
- detections of microarousals(Night of simultaneous PSG and mattress recording)
- Diagnostic accuracy by age group.(Night of simultaneous PSG and mattress recording (one night per participant).)
- Subjective sleep quality (GSQS-8).(Night of simultaneous PSG and mattress recording (one night per participant).)
- Descriptive demographic data.(Night of simultaneous PSG and mattress recording (one night per participant).)
- Sleep efficiency(Night of simultaneous PSG and mattress recording)
- Sleep stage(Night of simultaneous PSG and mattress recording)