The IPAD Cohort Study: Insomnia and Positive Airway Pressure Adherence in Children and Adolescents
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: Positive airway pressure therapy.
- Кому может быть актуально
- Состояния в реестре: Sleep Apnea, Obstructive, Insomnia. Базовые параметры: 8 лет — 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 →
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Обзор
Positive Airway Pressure (PAP) is a treatment used to help people with sleep-disordered breathing, particularly those with obstructive sleep apnea (OSA). The device delivers pressurized air through a mask to keep the airways open during sleep, improving breathing and preventing interruptions in sleep. Studying how insomnia affects PAP adherence in children can help improve future treatments. However, no long-term studies have looked at this in children. Based on previous research, the investigators plan to conduct a study across multiple centers focusing on children with OSA starting PAP therapy. The study will explore how insomnia affects PAP adherence and how race and ethnicity play a role.
Подробное описание
The first line of treatment for obstructive sleep apnea (OSA) is positive airway pressure (PAP) therapy, yet children have a less than 50% adherence rate, leaving many undertreated for this condition. Insomnia has been established as a modifiable risk factor for lowering PAP therapy adherence in adults with comorbid insomnia and sleep apnea (COMISA), and research has shown that treating insomnia with cognitive behavioural therapy for insomnia (CBTi) improved PAP adherence in adults. This is an important step forward for improving COMISA treatment outcomes, but cannot yet be applied to children without researching this relationship in paediatric populations. This study will address this research gap by conducting a thorough, in-depth evaluation of the association between paediatric COMISA and PAP adherence. The investigators aim to find whether a causal relationship exists between insomnia and PAP adherence in children with OSA, which has never been assessed longitudinally in children.
This multicenter study will be conducted at two tertiary care academic hospitals: The Hospital for Sick Children (Toronto, Canada) and British Columbia Children's Hospital (BCCH) (Vancouver, Canada). This study will include 82 participants from a diverse population to assess the association between race and ethnicity with PAP therapy adherence, based on previous research showing that being part of a self-identified minority is associated with lower PAP therapy adherence. Participants and caregivers will be asked to complete questionnaires regarding insomnia, sleep behaviour and quality of life at baseline prior to PAP therapy initiation. Electronic follow up questionnaires will be administered at 1, 2, and 3 months after PAP therapy initiation and PAP download data will be completed remotely. The primary objective of this study is to evaluate the impact of baseline insomnia on PAP therapy adherence at 3 months based on self-identified racial and ethnic minority. The results of this study will provide treatment insight and improvement to children with COMISA being treated with PAP therapy.
Вмешательства
- Устройство Positive airway pressure therapy
Initiation of continuous or bilevel positive airway pressure therapy
Первичные конечные точки
- Mean minutes of nightly PAP usage [Срок оценки: 90 days]
Вторичные конечные точки (12)
- Mean minutes of nightly PAP usage [Срок оценки: 30, 60 days]
- Self-Reported Sense of Mastery (Caregiver) [Срок оценки: 0, 90 days]
- Self-Reported Sense of Mastery (Participant) [Срок оценки: 0, 90 days]
- Self-Reported Psychological Scale (Percentage Rank) [Срок оценки: 0, 90 days]
- Self-Reported Psychological Scale [Срок оценки: 0, 90 days]
- Self-Reported Sleep Diary [Срок оценки: 0, 90 days]
- Caregiver-Reported Insomnia Questionnaire [Срок оценки: 0, 90 days]
- Self-Reported Insomnia Questionnaire (Participant) [Срок оценки: 0, 30, 60, 90 days]
- Self-Reported Insomnia Questionnaire (Participant) [Срок оценки: 0, 30, 60, 90 days]
- Self-Reported Insomnia Questionnaire (Caregiver) [Срок оценки: 0, 90 days]
- Self-Reported Insomnia Questionnaire (Caregiver) [Срок оценки: 0, 90 days]
- Self-Reported Chronotype Questionnaire [Срок оценки: 0, 90 days]
Критерии участия
Критерии включения
- Children aged 8-18 years old
- Obstructive apnea-hypopnea index ≥ 5/hour on baseline diagnostic polysomnogram (PSG)
- Newly prescribed PAP therapy
Критерии исключения
1\) Developmental disability precluding ability to answer questionnaires
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Канада · 1 центр
- British Columbia Children's Hospital — Vancouver
Идентификаторы
NCT: NCT07176767 · H25-00289 · 354-FP-24