Evaluation of the Diagnostic Capacity of a Smart Mattress Versus Conventional Polysomnography
Key facts
- Who runs it
- Hospital San Pedro de Logroño
- Where
- Logroño, SpainSee the 2 sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 500 people, planned
- Starts
- 17 Nov 2026
- Expected to end
- 1 Mar 2028
- Type of study
- Observational
- Treatments tested
- Integrated polysomnographic assessment with smart mattress.
- Record updated
- 3 March 2026
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- Polysomnographies performed at San Pedro Hospital between November 17, 2026, and March 1, 2028
- 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)
Who cannot take part
- 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
Where in Spain
- Center for Biomedical Research of La RiojaLogroño, SpainContact: Alejandra Roncero Lázaro, MDNo longer taking part
- San Pedro University HospitalLogroño, SpainContact: Alejandra Roncero Lázaro, MDNo longer taking part
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- 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.
Treatment: Integrated polysomnographic assessment with smart mattress.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 3 March 2026