Validation and Usability Study of the SleepView+ Home Sleep Testing System for the Evaluation of Moderate to Severe Obstructive Sleep Apnea.

Официальное название

SleepView+ Validation Testing

Обзор

The goal of this observational study is to characterize the performance of the SleepView+ home sleep test system for the evaluation of moderate to severe obstructuve sleep apnea (OSA) in adult and pediatric patients (ages 12 and over). This study is being conducted in patients being evaluated for a sleep disorder who are scheduled to undergo an in lab polysomnigraphic study (PSG), enriching for suspected obstructive sleep apnea. This study will involve two phases: A - comparison of SleepView+ detection of apneas and hypopneas to simultaneously collected in lab PSG (validation phase) and B - evaluation of the ability of patients to use the SleepView+ system in their home environment without sleep technologist support (usability phase) Participants will progress from phase A to phase B.

Подробное описание

This study is a validation and usability study of the SleepView+ home sleep test for assessing obstructive sleep apnea. The SleepView+ device consists of multiple peripheral sensors that are designed to be placed by patients themselves. The system is intended to be operable by patients without technologist intervention.

The study will first evaluate the ability of SleepView+ to diagnose moderate to severe obstructive sleep apnea, as compared to in lab polysomnography. In a second usability phase, participants will take the SleepView+ device home and record a second night without technologist or expert supervision/assistance. Usability surveys and data quality metrics will be collected to assess the ability of participants (or their caregivers) to successfully operate the device in its intended at-home use.

Вмешательства

• Устройство SleepView+
  Participants will wear the SleepView+ sleep monitor during both their in lab overnight PSG (for validation of apnea and hypopnea detection versus gold-standard clinical in-lab PSG), and then subsequently at home (to assess device usability).

Первичные конечные точки

• Diagnosis of moderate to severe obstructive sleep apnea (OSA) [Срок оценки: 5 months]

Вторичные конечные точки (3)

• Usability metrics [Срок оценки: 5 months]
• Diagnotic accuracy for mild OSA [Срок оценки: 5 months]
• Diagnostic accuracy for severe OSA [Срок оценки: 5 months]

Критерии участия

Критерии включения

• ≥ 12 years of age
• Referred to a sleep lab study site with a clinical indication for an overnight PSG (either full-night or split-night PSG/PAP titration sleep study)

Критерии исключения

• Age <12 yrs
• Participants who cannot read written instructions in English, have significant cognitive impairment or are otherwise unable to provide informed consent
• Concomitant enrollment in another study protocol that may interfere with data acquisition or reliability of measurements
• Known to be pregnant at time of recruitment
• Stroke or myocardial infarction within 6 months sleep study
• Deemed unsuitable for selection by the research team or medical team due to any medical, legal, social, or interpersonal issues, that would either compromise the study or the routine care of patients.
• Any other medical condition considered high risk or that may impact device usage, as determined by the site PI or medical monitor

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Экологическое

Центры проведения

США · 4 центра

• Redwood Pulmonary Medical Associates — Redwood City
• Sleep Insights — Rochester
• West Region Sleep Center — Cleveland
• Sleep Therapy & Research Center — San Antonio

Идентификаторы

NCT: NCT07476313 · SV-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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