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Набор скоро начнётся NCT05457127

Obstructive Sleep Apnea Treatment in Serious Mental Illness

Без фазы С лечением Schizoaffective Disorder Schizophrenia Bipolar Disorder Obstructive Sleep Apnea of Adult

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Automatic Positive Airway Pressure (APAP).
Кому может быть актуально
Состояния в реестре: Schizoaffective Disorder, Schizophrenia, Bipolar Disorder, Obstructive Sleep Apnea of Adult. Базовые параметры: 40 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Obstructive Sleep Apnea Treatment in People Aging With Serious Mental Illness

Обзор

Serious mental illnesses (SMI) like schizophrenia and bipolar disorder are two of the most disabling and costly chronic illnesses worldwide. A high proportion of adults with schizophrenia and bipolar disorder have sleep disorders, like obstructive sleep apnea (OSA), but tend to be underdiagnosed and undertreated compared to the general population. This study aims to examine feasibility, acceptance, and impact of OSA treatment and how it affects cognitive function in people with SMI.

Подробное описание

Sleep disturbances are central to many psychiatric disorders, including schizophrenia and bipolar disorder, with clear implications for cognition, brain health, physical health and aging. Obstructive sleep apnea (OSA) is typically underdiagnosed and undertreated due to impairment from psychiatric symptoms, limited resources, and stigma. In turn, consequences of untreated OSA in SMI are dire: in particular, worsening cardiometabolic health, cognitive decline, and death. Few studies have examined the impact of treatments for obstructive sleep apnea on cognitive problems in a high-risk group, such as older adults with SMI. The goals of the proposed study are to assess the acceptance and effectiveness of positive airway pressure (PAP) treatment for OSA, and its impact on cognitive and cardiometabolic outcomes as well as biological processes over a 3-month period. In order to determine eligibility, participants will be asked to complete a diagnostic test either at home or overnight in-lab. If diagnosed with sleep apnea, the participant will be offered a 3-month treatment with an automatic PAP. In addition, eligible participants will complete weekly check-ins with study staff and a series of detailed interviews, physical and neuropsychological tests, instrumental and clinical assessments, and blood draws every month for a total of 3 months.

Вмешательства

  • Устройство Automatic Positive Airway Pressure (APAP)
    If eligible, participants will be given a clinical Automatic Positive Airway Pressure (APAP) device for up to 3 months, while they are waiting for their clinical evaluation from a sleep physician. The APAP device will we will be using is the ResMed Airsense 11 Autoset. APAP is a smart positive airway pressure (PAP) device, where the pressure changes as needed to provide optimal pressure to splint the upper airway. Dr. Lee and Dr. Schmickl will oversee management of the device. During the first

Первичные конечные точки

  • Acceptance of PAP trial [Срок оценки: 3 months]
  • OSA self-efficacy using the SEMSA [Срок оценки: 3 months]
  • PAP usage [Срок оценки: 3 months]
  • Cognitive Functioning [Срок оценки: 3 months]
  • Monitoring Slow Wave Sleep and Sleep Spindle Density [Срок оценки: 3 months]

Критерии участия

Критерии включения

Control participants:

  • lifetime absence of major psychiatric illness
  • 40 to 70 years old
  • be at risk for or have a diagnosis of obstructive sleep apnea

For participants with serious mental illness:

  • diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
  • must not be conservatized
  • 40 - 70 years old
  • be at risk or have a diagnosis of obstructive sleep apnea.

Критерии исключения

  • DSM-IV-TR diagnosis of active alcohol or other substance abuse or dependence in the 3 months preceding enrollment. This will be self-report.
  • Diagnosis of dementia, mental retardation, or other neurological or medical conditions known to affect neurophysiologic or neurocognitive functioning, or autoimmune disease
  • Other major DSM-IV-TR Axis I Disorder
  • Medical problems that interfere with a participant's ability to complete the assessments
  • Plans to move out of the San Diego county area within the following 6 months
  • Diagnosis of OSA and currently receiving APAP, CPAP, or any treatment from a physician.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UCSD — La Jolla

Идентификаторы

NCT: NCT05457127 · 800600

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗