Sleep Apnea Syndromes Clinical Trial
— ScreenOXOfficial title:
New Out-of-center Paradigms to Simplify Sleep Apnea Diagnosis. Design and Development of an Automated Screening Test Based on Oximetry (ScreenOX)
The sleep apnea-hypopnea syndrome (SAHS) is a respiratory disorder characterized by frequent breathing cessations (apneas) or partial collapses (hypopneas) during sleep. SAHS is linked with the most important causes of death in adults from industrialized countries. Metabolic deregulation and cardiovascular and cerebrovascular diseases, such as atrial fibrillation, stroke, myocardial infarction and sudden cardiac death, could affect people having untreated SAHS. The gold standard method for SAHS diagnosis is in-hospital, technician-attended nocturnal polysomnography (PSG). Nevertheless, this methodology is labor-intensive, time-consuming, and relatively unavailable, especially in low-resource settings. These drawbacks have led to large waiting lists, which delay diagnosis and treatment and limits its effectiveness as single diagnostic method for SAHS. Blood oxygen saturation (SpO2) and pulse rate (PR) from nocturnal pulse oximetry (NPO) provide relevant and essential information to detect apneas. In addition, it is significantly less intrusive for patients and it can be easily recorded at patients' home. In the same way, automated signal processing and pattern recognition techniques have demonstrated to provide accurate tools able to detect and effectively use this information. Therefore, the investigators hypothesize that automated pattern recognition of at-home NPO recordings could provide reliable and efficient tools able to simplify the management of SAHS. The aim of this study is two-fold: 1) to prospectively assess the reliability and effectiveness of at-home NPO in the context of adult SAHS; 2) to design, optimize and extensively assess the diagnostic performance of automated NPO-based screening tools for SAHS. In order to achieve these goals, both PSG and NPO recordings are carried out ambulatory and simultaneously at patient's home. A portable polysomnograph (Embletta MPR, Natus) is used for standard PSG at home, whereas a portable wrist-worn pulse oximeter (WristOX2 3150, Nonin) is used for ambulatory NPO. In addition, conventional in-lab PSG and attended pulse oximetry are also performed simultaneously in the hospital facilities.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Men and women over 18 years old - Subjects derived from primary care to the sleep specialized outpatient facilities showing moderate-to-high clinical suspicion of suffering from sleep apnea (daytime hypersomnolence, loud snoring, nocturnal choking and awakenings, and/or apneic events) - Written informed consent signed Exclusion Criteria: - Subjects under 18 years old - Subjects not signing the informed consent - Presence of any previously diagnosed sleep disorder: narcolepsy, insomnia, chronic sleep deprivation, regular use of hypnotic or sedative medications and/or restless leg syndrome. - Patients with the following chronic diseases: congestive heart failure, renal failure, neuromuscular diseases, chronic respiratory failure. - Patients with >50% of central apneas or the presence of Cheyne-Stokes respiration. - Previous continuous positive airway pressure (CPAP) treatment for SAHS diagnosis - A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions |
Country | Name | City | State |
---|---|---|---|
Spain | Río Hortega University Hospital | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Hospital del Río Hortega | Five Flames Mobile, OXIGEN salud, University of Valladolid |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients correctly classified | Percentage of patients (%) correctly classified/screened by the automated NPO-based screening test. At-home ambulatory PSG is used as the gold standard method for positive SAHS. Subjects with apnea-hypopnea index (AHI) <5 are considered no-SAHS subjects, with 5<=AHI<15 as mild SAHS patients, with 15<=AHI<30 moderate SAHS patients, and AHI>=30 as severe SAHS patients. | 6 months after the inclusion of the last patient | |
Secondary | Body mass index | Average (median and interquartile range) body mass index (kg/m2) of the cohort. | 6 months after the inclusion of the last patient | |
Secondary | Patients with chronic obstructive pulmonary disease | Number of patients (n) with comorbid chronic obstructive pulmonary disease (COPD), according to standard definitions. | 6 months after the inclusion of the last patient | |
Secondary | Patients with hypertension | Number of patients (n) with comorbid arterial hypertension (HT), according to standard definitions. | 6 months after the inclusion of the last patient | |
Secondary | At-home PSG-derived AHI | Apnea-hypopnea index (events per hour) derived from unattended PSG at patients' home. | 6 months after the inclusion of the last patient | |
Secondary | At-home PSG-derived time in REM sleep | Percentage of time (%) in rapid eye movement (REM) sleep to the total sleep time derived from unattended PSG at patients' home. | 6 months after the inclusion of the last patient | |
Secondary | At-home PSG-derived sleep efficiency | Sleep efficiency (%) measured as the percentage of total sleep time to the total recording time derived from unattended PSG at patients' home. | 6 months after the inclusion of the last patient | |
Secondary | At-home PSG-derived arousal index | Number of arousals per hour of sleep (events per hour) derived from unattended PSG at patients' home. | 6 months after the inclusion of the last patient | |
Secondary | At-home PSG-derived time in supine position | Percentage of time (%) in supine position to the total sleep time derived from unattended PSG at patients' home. | 6 months after the inclusion of the last patient | |
Secondary | At-home PSG-derived average SpO2 | Average overnight SpO2 (%) from unattended PSG at patients' home. | 6 months after the inclusion of the last patient | |
Secondary | At-home PSG-derived minimum SpO2 | Minimum overnight SpO2 (%) from unattended PSG at patients' home. | 6 months after the inclusion of the last patient | |
Secondary | At-home PSG-derived oxygen desaturation index of 3% (ODI3) | Number of desaturations greater than or equal to 3% from baseline per hour of sleep (events per hor) from unattended PSG at patients' home. | 6 months after the inclusion of the last patient | |
Secondary | At-home NPO-derived ODI3 | Number of desaturations greater than or equal to 3% from baseline per hour of recording (events per hor) from unattended pulse oximetry at patients' home. | 6 months after the inclusion of the last patient | |
Secondary | At-home NPO-derived cumulative time below 90% (CT90) | Percentage (%) of cumulative time with a saturation below 90% from unattended pulse oximetry at patients' home. | 6 months after the inclusion of the last patient | |
Secondary | At-home NPO-derived average SpO2 | Average saturation (%) from unattended pulse oximetry at patients' home. | 6 months after the inclusion of the last patient | |
Secondary | At-home NPO-derived minimum SpO2 | Minimum saturation (%) from unattended pulse oximetry at patients' home. | 6 months after the inclusion of the last patient | |
Secondary | At-home NPO-derived average pulse rate | Average pulse rate (beats per minute) from unattended pulse oximetry at patients' home. | 6 months after the inclusion of the last patient | |
Secondary | At-home NPO-derived minimum pulse rate | Minimum pulse rate (beats per minute) from unattended pulse oximetry at patients' home. | 6 months after the inclusion of the last patient | |
Secondary | Prevalence of SAHS | Prevalence of SAHS (%) in the population under study according to at-home PSG. | 6 months after the inclusion of the last patient | |
Secondary | Severity of SAHS | Number of patients (n) with moderate-to-severe SAHS according to the at-home PSG-derived patient's AHI. | 6 months after the inclusion of the last patient | |
Secondary | NPO-derived ODI3 agreement | Mean difference (mean +/- 1.96 standard deviation interval) from the Bland and Altman agreement plot between unattended ODI3 from at-home NPO and supervised ODI3 from in-hospital NPO. | 6 months after the inclusion of the last patient | |
Secondary | PSG-derived AHI agreement | Mean difference (mean +/- 1.96 standard deviation interval) from the Bland and Altman agreement plot between unattended AHI from at-home PSG and supervised AHI from in-hospital PSG. | 6 months after the inclusion of the last patient | |
Secondary | Optimum diagnostic performance - Area under the ROC curve | Area under the receiver operating characteristics (ROC) curve of the optimum NPO-based binary classifier compared to standard at-home PSG. | 6 months after the inclusion of the last patient | |
Secondary | Optimum diagnostic performance - Accuracy | Accuracy (percentage, %) of the optimum NPO-based binary classifier compared to standard at-home PSG. | 6 months after the inclusion of the last patient | |
Secondary | Optimum agreement - Intra-class correlation coefficient | Intra-class correlation coefficient (ICC) between the optimum NPO-based estimated AHI and the actual AHI derived from at-home PSG. | 6 months after the inclusion of the last patient | |
Secondary | Patient's Sleep quality | Patients' sleep quality assessment using the Pittsburg questionnaire. | 6 months after the inclusion of the last patient | |
Secondary | Patient's somnolence | Patients' somnolence assessment using the Epworth questionnaire. | 6 months after the inclusion of the last patient | |
Secondary | Patients' quality of life | Patients' quality of life assessment using the Quebec sleep questionnaire (QSQ). | 6 months after the inclusion of the last patient | |
Secondary | Percentage of unsatisfactory recordings | Number of recordings (n) removed from the study due to reasons (either technical or human) related to unattended portable oximetry. | 6 months after the inclusion of the last patient |
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