Home-based Under Mattress Monitor for OSA

Официальное название

Home-Based Under-Mattress Monitoring Device to Estimate Mandibular Advancement in Oral Appliance Therapy for Obstructive Sleep Apnea

Обзор

The aim of the study is to evaluate the effectiveness of the under-mattress monitoring device to aid in the titration process of a mandibular advancement device (MAD) for the management of obstructive sleep apnea (OSA). A secondary aim is to evaluate changes in subjective OSA symptoms and patient's satisfaction with MAD. A third aim is to analyze if there are differences between the sleep parameters recorded by the under-mattress monitor between responders and non-responders to MAD therapy.

Вмешательства

• Устройство Under-mattress monitor
  the under-mattress monitor will be used in conjunction with the Alice NightOne at the beginning and end of the study, in addition, the under-mattress monitor will be used daily during sleep with the intraoral device in situ
• Устройство level 3 Home Sleep Apnea Test
  Home sleep apnea test with Alice NightOne will be used for one day during sleep at the beginning and end of the study in conjunction with the Sleeptracker AI and the intraoral device.
• Устройство Mandibular Advancement Device (MAD)
  CAD-CAM, US Food and Drug Administration (FDA)-approved MAD, duo-bloc, customized, titratable sleep appliance. Participants will return every 2 weeks to the Orofacial Pain (OFP) clinic to progressively titrate the MAD advancement as needed until the under-mattress monitor scores an AHI \< 5

Первичные конечные точки

• Change in apnea-hypopnea index (AHI). [Срок оценки: Baseline and post-intervention (approximately 12 weeks)]
• Change in minimum oxygen desaturation level [Срок оценки: Baseline and post-intervention (approximately 12 weeks)]

Вторичные конечные точки (6)

• Change in Epworth Sleepiness Scale [Срок оценки: Baseline and post-intervention (approximately 12 weeks)]
• Change in Quality of Life Scale [Срок оценки: Baseline and post-intervention (approximately 12 weeks)]
• Change in Fatigue Assessment Scale [Срок оценки: Baseline and post-intervention (approximately 12 weeks)]
• Change in Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline and post-intervention (approximately 12 weeks)]
• Change in Snore Outcomes Survey (SOS) [Срок оценки: Baseline and post-intervention (approximately 12 weeks)]
• Short Assessment of Patient Satisfaction [Срок оценки: Post Intervention, approximately week 12]

Критерии участия

Критерии включения

• Diagnosis of Obstructive Sleep Apnea demonstrated with a sleep study polysomnography or home sleep study (PSG or HSAT), manually scored by a sleep physician according to the 2017 American Academy of Sleep medicine scoring guidelines.
• Willingness to commute to the OFP clinic every 2 weeks during MAD titration period.
• Consent to partake in the study.

Критерии исключения

• Diagnosis of central or mixed sleep apnea.
• Neurocognitive disease.
• Concomitant therapy with PAP therapy.
• Allergic to the appliance material (Polyamide 12).
• Presence of active dental decay, ill-fitting dental restorations, or crown to root ratio unfavorable.
• Inadequate English language comprehension.
• Lack of coordination or dexterity to insert/remove the MAD intraorally.
• Inability to tolerate digital dental impressions.
• Patients with concomitant diagnosed sleep disorders, including narcolepsy, restless leg syndrome, rapid eye movement sleep behavior disorder).

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

Диагностика

Центры проведения

США · 1 центр

• University of Kentucky — Lexington

Идентификаторы

NCT: NCT07186725 · 97445

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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