Assessment of Sleep Complaints in Brain Tumor Survivors

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Спонсоры

St. Jude Children's Research Hospital

КЛИНИЧЕСКИЕ ИСПЫТАНИЯ: NCT01102998

BioSeek: NCT01102998

Ключевые слова

химиотерапия злокачественных новообразований

абстрактный

Survivors of pediatric brain tumors are noted to have increased rates of excessive daytime sleepiness. However, very little data are available regarding the specific sleep disturbances of pediatric brain tumor survivors. Children ages 8 to 18 years of age who are at least 5 years from diagnosis and at least 2 years post treatment or observation only for a brain tumor will be targeted to assess the prevalence of sleep complaints.

The study focuses on the following objectives:

- To estimate sleep disturbance in a cohort of pediatric brain tumor survivors.

- Estimate the rates of parent- and self-reported excessive daytime sleepiness in pediatric brain tumors

- Estimate the rates of parent-reported sleep-disordered breathing, including snoring and witnessed apneas, in pediatric brain tumor survivors

- Estimate the rates of parent- and self-reported behavioral sleep problems, including nocturnal enuresis, bedtime resistance, nighttime awakenings, nightmares, and fatigue in pediatric brain tumor survivors.

The Study focuses on the following secondary objectives:

- To describe bedtime patterns and sleep hygiene of pediatric brain tumor survivors.

- Estimate the typical parent- and self-reported weekday sleep duration of pediatric brain tumor survivors

- Estimate the typical parent- and self-reported weekend sleep duration of pediatric brain tumor survivors and if it differs from the weekday sleep duration

- Estimate the typical parent- and self-reported consistency of sleep hygiene in pediatric brain tumor survivors

Описание

This non-therapeutic single arm study will characterize the prevalence and types of sleep complaints of pediatric brain tumor survivors. Brain tumor survivors ages 8 to 18 years who are at least 5 years post diagnosis and 2 years post active therapy and their parents/guardians will be approached to participate during clinic visits. If the patient and guardian agree to participate, they will be administered three questionnaires in the clinic during the patient's visit. From the medical record, the following variables will be utilized to characterize the subjects and estimate which groups are at greatest risk of sleep disturbances:

- Specific brain tumor diagnosis

- Location of tumor (cerebral hemispheres, parasellar region, posterior fossa, or spine)

- Age at diagnosis

- Obesity status

- Treatment modality (surgery, radiation therapy, and/or chemotherapy vs. observation only)

Даты

Последняя проверка:	10/31/2013
Первый отправленный:	04/11/2010
Предполагаемая регистрация отправлена:	04/11/2010
Первое сообщение:	04/12/2010
Последнее обновление отправлено:	11/14/2013
Последнее обновление опубликовано:	11/17/2013
Фактическая дата начала исследования:	03/31/2010
Предполагаемая дата завершения начальной школы:	08/31/2012
Предполагаемая дата завершения исследования:	03/31/2013

Состояние или болезнь

Brain Tumors

Фаза

Группы рук

Рука	Вмешательство / лечение
Brain Tumor Survivors Brain tumor survivors ages 8 to 18 years who are at least 5 years post diagnosis and at least 2 years post active therapy or observation and their parents/guardians will be approached to participate during clinic visits.

Критерии приемлемости

Возраст, имеющий право на обучение	8 Years Чтобы 8 Years
Полы, имеющие право на обучение	All
Метод отбора проб	Non-Probability Sample
Принимает здоровых добровольцев	да
Критерии	Inclusion Criteria: - Age ≥8 to ≤ 18 years of age - Brain tumor survivor - ≥5 years post diagnosis - ≥2 years post active cancer-directed therapy or observation only - Parents speak and read English fluently - Potential participant reads English fluently - Potential participant/guardian willing to sign consent Exclusion Criteria: - Survivor of any cancer other than a brain tumor.

Результат

Основные показатели результатов

1. Sleep disturbance in a cohort of pediatric brain tumor survivors. [2 years]

Estimate the rates of parent- and self-reported excessive daytime sleepiness in pediatric brain tumors Estimate the rates of parent-reported sleep-disordered breathing, including snoring and witnessed apneas, in pediatric brain tumor survivors Estimate the rates of parent- and self-reported behavioral sleep problems, including nocturnal enuresis, bedtime resistance, nighttime awakenings, nightmares, and fatigue in pediatric brain tumor survivors.

Assessment of Sleep Complaints in Brain Tumor Survivors

Ключевые слова

опухоль головного мозга

злокачественная опухоль

переутомление

храп

сомнолентность

энурез

enuresis

ожирение

противогрибковые средства