Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
A Prospective Observational Study to Develop and Validate a Multimodal Deep Learning Model Integrating Peripheral Oxygen Saturation and Ballistocardiography Signals for the Prediction of Apnea-Hypopnea Index in Patients With Suspected Obstructive Sleep Apnea
Obstructive sleep apnea (OSA) is a common sleep disorder associated with cardiovascular, metabolic, and neurocognitive complications. The standard diagnostic test for OSA is in-laboratory polysomnography (PSG), which can be costly, labor-intensive, and inconvenient for repeated or large-scale screening. Therefore, there is a need for a convenient and non-invasive method to help identify individuals who may be at risk for OSA.
This prospective observational study aims to develop and clinically validate a multimodal deep learning model that integrates peripheral oxygen saturation (SpO₂) signals and ballistocardiography (BCG) data collected using a smart mattress system to estimate the apnea-hypopnea index (AHI). Adult participants undergoing routine overnight PSG for suspected OSA will be enrolled. During sleep, synchronized SpO₂ and BCG signals will be recorded non-invasively.
The performance of the deep learning model will be evaluated by comparing the predicted AHI values with AHI values derived from PSG. This study seeks to evaluate whether this practical, non-invasive, and scalable approach may support early identification of OSA risk and improve access to sleep disorder assessment in both clinical and home-based settings.
Visão geral do estudo
Status
Status
Condições
Condições
Descrição detalhada
This is a prospective observational cohort study designed to develop and validate a multimodal deep learning-based model for estimating obstructive sleep apnea (OSA) severity. Adult participants with suspected OSA who are scheduled to undergo overnight in-laboratory polysomnography (PSG) will be recruited at Fu Jen Catholic University Hospital.
During the PSG examination, participants will simultaneously undergo non-invasive physiological signal acquisition using a smart mattress system equipped with ballistocardiography (BCG) sensors, along with continuous peripheral oxygen saturation (SpO₂) monitoring. These signals will be time-synchronized with PSG recordings. No experimental intervention or alteration to standard clinical care will be performed.
Multimodal deep learning algorithms incorporating convolutional neural networks and sequence-based architectures will be developed to analyze SpO₂ and BCG signals and to estimate the apnea-hypopnea index (AHI). Model performance will be assessed by comparing predicted AHI values with PSG-derived AHI using predefined statistical metrics.
The primary objective is to evaluate the accuracy of AHI prediction using the proposed multimodal model. Secondary objectives include assessment of model discrimination for OSA severity classification and exploratory analyses of physiological signal features associated with sleep-disordered breathing. All analyses will be conducted using de-identified data. This study does not involve U.S. FDA-regulated drugs or devices and is not conducted under an investigational new drug application or investigational device exemption.
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: Ke-Yun Chao Principal Investigator
- Número de telefone: +886-905-301-879
- E-mail: C00152@mail.fjuh.fju.edu.tw
Locais de estudo
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New Taipei City
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New Taipei City, New Taipei City, Taiwan, 24352
- Recrutamento
- Fu Jen Catholic University Hospital
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Contato:
- Clinical Research Coordinator
- Número de telefone: +886-2-2905-2000
- E-mail: Ck_qq@hotmail.com
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Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Adult individuals aged 20 years or older who are referred to Fu Jen Catholic University Hospital for in-laboratory polysomnography due to suspected obstructive sleep apnea will be invited to participate. The study population includes participants with a wide range of apnea-hypopnea index values, including individuals without obstructive sleep apnea based on polysomnography results.
Descrição
Inclusion Criteria:
- Adults aged 20 years or older.
- Individuals referred for in-laboratory polysomnography due to suspected obstructive sleep apnea.
- Able and willing to provide informed consent.
Exclusion Criteria:
- Inability to provide informed consent.
- Presence of conditions that may interfere with sleep signal acquisition, as determined by the investigator.
- Prior diagnosis of sleep disorders other than obstructive sleep apnea that could confound study results.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Número de grupos/coortes
Coortes e Intervenções
Grupo / CoorteGrupo / Coorte |
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Adults With Suspected Obstructive Sleep Apnea
This cohort includes adult participants with suspected obstructive sleep apnea who are scheduled to undergo overnight in-laboratory polysomnography. All participants will receive standard clinical polysomnography while simultaneously undergoing non-invasive physiological signal acquisition using a smart mattress system and peripheral oxygen saturation monitoring. No experimental intervention or treatment assignment is performed. |
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Mean absolute error of apnea-hypopnea index estimation
Prazo: Two overnight assessments per participant: one in-laboratory polysomnography night and one subsequent home sleep monitoring night.
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Mean absolute error (MAE) will be calculated as the average absolute difference between the apnea-hypopnea index (AHI) predicted by the multimodal deep learning model using peripheral oxygen saturation (SpO2) and ballistocardiography (BCG) signals collected during home sleep monitoring and the AHI measured by in-laboratory polysomnography (PSG). The analysis will include participants with evaluable paired PSG and home monitoring data. MAE will be reported in events per hour, with lower values indicating better predictive performance. |
Two overnight assessments per participant: one in-laboratory polysomnography night and one subsequent home sleep monitoring night.
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- FJUH115580
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual participant data will not be shared publicly.
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