Effectiveness of Audio Cues to Achieve Positional Therapy in Patients With Positional Obstructive Sleep Apnea

Официальное название

Effectiveness of WhisperPT's Audio Cues to Achieve Positional Therapy in Patients With Positional Obstructive Sleep Apnea

Обзор

Patients with obstructive sleep apnea (OSA) often experience more frequent and severe breathing disturbances when sleeping in the supine (back-sleeping) position compared with non-supine positions. Positional therapy aims to reduce time spent sleeping in the supine position, but existing treatment options may be limited by comfort and effectiveness. This study evaluates the effectiveness and usability of WhisperPT, an investigational in-ear positional therapy device that delivers gentle audio cues during sleep to encourage participants to move from the supine to a non-supine sleeping position. The study will assess the device's ability to reduce the apnea-hypopnea index (AHI), decrease time spent sleeping supine, and evaluate participant comfort and ease of use.

Вмешательства

• Устройство Investigational Positional Therapy Device
  The investigational intervention is a non-invasive, investigational in-ear positional therapy device worn in the ear during sleep. The device continuously monitors head position and delivers gentle audio cues when the participant remains in the supine (back-sleeping) position to encourage a return to a non-supine sleeping position. The device is evaluated as part of a structured protocol including baseline assessment, acclimation, and treatment nights.

Первичные конечные точки

• Participants Achieving ≥50% Reduction in AHI [Срок оценки: Intervention assessment (Night 5), within approximately 7 days]

Вторичные конечные точки (2)

• Proportion of participants with supine sleep percentage of less than 15% [Срок оценки: Intervention assessment (Night 5), within approximately 7 days]
• Self-reported Comfort, Overnight Retention, and Ease of Device Use [Срок оценки: Study completion (approximately 7 days)]

Критерии участия

Критерии включения

• Diagnosing sleep study identified a significant positional component to their obstructive sleep apnea (OSA) diagnosis as measured by at least a 50% reduction in Apnea-Hypopnea Index (AHI) while sleeping non-supine compared to supine
• Diagnosing sleep study included at least 40% of the night recorded in supine and at least 20% of the night in non-supine position
• Have an overall AHI > 10 (4% desaturation)
• Diagnosing sleep study included a minimum of 5 hours total sleep time (TST)
• Willing to abstain from use of any other treatments for sleep-disordered breathing beginning at least 3 days prior to at-home study testing and for the remaining duration of their study participation
• Between ages 18-75
• Must be able to refrain from alcohol use during nights of at-home study testing
• Speaks and reads English sufficiently to understand the study informed consent, study instructions, and study materials
• Signs study-specific informed consent form

Критерии исключения

-Active medical conditions that would prevent study participation as determined by the principal investigator, including: Inability to easily move from between back and side in both directions Inability to sleep in lateral or supine position due to injury or a medical condition OR inability to sleep in a non-elevated/ tilted bed

• Requiring medications to sleep
• Prior diagnosis of a significant other sleep disorder such as restless leg syndrome/periodic limb movement disorder, primary central sleep apnea, pronounced insomnia, parasomnias, central disorder of hypersomnolence, etc
• An active ear infection OR an ear infection within the past month OR a history of >3 ear infections per year
• Unusual outer ear, including enlarged or extra small anatomy, that prevents device use
• Significant hearing impairment or ear skin issues, including:

Participants with cochlear implants or those who will be affected by small magnets in the ear

• Suffering from tinnitus
• BMI >35
• Current use of any illegal drugs.
• Currently pregnant or currently lactating
• Current enrollment in a clinical study of any other unapproved investigational drug or device.
• Inability or unwillingness to comply with the study requirements.
• Any other condition or laboratory value that could, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the participant.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Peninsula Sleep Center — Burlingame

Идентификаторы

NCT: NCT07714330 · CIP-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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