ScreenOX - An Automated At-home Screening Test for Adult Sleep Apnea Using Nocturnal Oximetry

NCT03295149 | Unknown

• 1 other identifier: RTC-2015-3446-1
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea Syndromes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

• Body mass index

  6 months after the inclusion of the last patient

• Patients with chronic obstructive pulmonary disease

  6 months after the inclusion of the last patient

• Patients with hypertension

  6 months after the inclusion of the last patient

• At-home PSG-derived AHI

  6 months after the inclusion of the last patient

• At-home PSG-derived time in REM sleep

  6 months after the inclusion of the last patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive subjects derived to the sleep specialized outpatient facilities showing moderate-to-high clinical suspicion of suffering from SAHS due to at least one of the following symptoms: daytime hypersomnolence, loud snoring, nocturnal choking and awakenings, and/or apneic events reported by the subject or the bedmate.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital del Rio Hortega: lead
• OXIGEN salud: collaborator
• University of Valladolid: collaborator
• Five Flames Mobile: collaborator

Study Sites (1)

Río Hortega University Hospital

Valladolid, 47012, Spain

RECRUITING

Related Links

• Web of the ScreenOX clinical trial
• Web of the Rio Hortega University Hospital, Spain
• Web of OXIGEN salud. Respiratory therapy provider, Spain
• Web of the Biomedical Engineering Group (GIB), University of Valladolid, Spain

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Félix Del Campo, PhD,MD

  Río Hortega University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Félix Del Campo, PhD, MD

CONTACT

+34 983420400; fsas@telefonica.net

Rosa Conde

CONTACT

+34 983420400; rconvi@saludcastillayleon.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 27, 2017
• Study Start: January 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 2, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)