Меню
Идёт набор NCT04007380

Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI

Без фазы С лечением Spinal Cord Injuries Sleep Apnea

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: Continuous positive airway pressure (CPAP) therapy.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries, Sleep Apnea. Базовые параметры: от 18 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing in Spinal Cord Injured People

Обзор

This clinical trial will examine the efficacy of continuous positive airway pressure (CPAP) therapy in improving psychosocial, neurocognitive and behavioral consequences of moderate-to-severe sleep-related breathing disorders (SRBDs) in people living with spinal cord injury (SCI).

Подробное описание

SCI is a potentially catastrophic event for individuals who may sustain motor, sensory, and autonomic deficit, as well as secondary conditions including SRBDs. The SRBDs include central, obstructive and mixed sleep apnea that can occur in up to 50% of the paraplegics and up to 91% of the motor complete tetraplegics. Although the frequency of SRBDs after SCI is much greater than in able-bodied people, this condition is still a largely under-recognized in the SCI population.

With this, the investigators hypothesize that regular use of CPAP for treatment of moderate-to-severe SRBDs in individuals living with SCI significantly improve their fatigue, depressive symptoms, anxiety, cognitive impairment, quality of life, and social and work participation. This research project will include: (i) a single-arm clinical trial to evaluate the efficacy of nightly use of CPAP for 4 consecutive months in the management of moderate-to-severe SRBDs among 24 adults with subacute to chronic, cervical or thoracic, complete or incomplete SCI; and (ii) a qualitative study of the challenges experienced by the 24 people with SCI who undergo an unattended-hospital or home-based sleep study for diagnosis of SRBDs followed by CPAP therapy.

Overall, this clinical study has the potential to ultimately improve fatigue, mood, cognition, quality of life, and social and work participation of people living with SCI, by examining under-explored links with the SRBDs.

Вмешательства

  • Другое Continuous positive airway pressure (CPAP) therapy
    The participants will undergo CPAP therapy for 4 consecutive months in the management of moderate-to-severe SRBDs

Первичные конечные точки

  • Fatigue Severity Scale [Срок оценки: Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy]
Вторичные конечные точки (4)
  • Epworth Sleepiness Score [Срок оценки: Change in Epworth Sleepiness Score from baseline to after 4-month period of CPAP therapy]
  • Medical Outcomes Study Sleep Scale [Срок оценки: Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy]
  • Depression, Anxiety & Stress Scales- 21 [Срок оценки: Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy]
  • Montreal Cognitive Assessment (MoCA) test [Срок оценки: Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy]

Критерии участия

Критерии включения

  • English-speaking adults 18 years of age or older
  • Have traumatic cervical/thoracic (injury level at C5 to T10), severe or moderate (AIS A, B, or C) SCI who were not diagnosed with a sleep disorder prior to the injury.
  • At least 2 months after injury
  • Clinical warning symptoms and/or signs for SRBDs

Критерии исключения

  • Patients with a non-traumatic spinal cord disease at risk for neurologic progression
  • Concomitant diseases of the central nervous system
  • Preinjury chronic pain
  • Psychiatric disorders that may prevent the participant to be compliant to the study protocol requirements
  • Neuromuscular diseases
  • Current substance misuse
  • History of primary hypersomnia
  • Hypothyroidism
  • Moderate or severe iron deficiency anemia
  • Active infection
  • Kidney failure
  • Epilepsy
  • Chronic fatigue syndrome
  • Vitamin B12 deficiency

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

Канада · 1 центр
  • Lyndhurst Centre, KITE - TRI UHN — Toronto

Идентификаторы

NCT: NCT04007380 · 19-5072

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗