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Идёт набор NCT05501678

Trial of Diphenhydramine for Sleep in Children With Autism

Фаза II С лечением Autism Autism Spectrum Disorder

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: Diphenhydramine, Placebo.
Кому может быть актуально
Состояния в реестре: Autism, Autism Spectrum Disorder. Базовые параметры: 8 лет — 17 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

Randomized Placebo-controlled Crossover Trial of Diphenhydramine for Sleep in Children With Autism

Обзор

The purpose of this study is to examine the effect of diphenhydramine on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Diphenhydramine is an anti-histaminergic agent with strong hypnotic properties. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of diphenhydramine on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

Вмешательства

  • Препарат Diphenhydramine
    25mg (and up to 50mg) Diphenhydramine given orally
  • Препарат Placebo
    Matching Placebo given orally

Первичные конечные точки

  • Change from baseline in sleep latency as measured by polysomnography (PSG) and/or actigraphy [Срок оценки: Baseline, Week 4 and Week 8]
  • Change from baseline in duration of non-rapid eye movement (NREM) sleep as measured by polysomnography (PSG) [Срок оценки: Baseline, Week 4 and Week 8]
Вторичные конечные точки (1)
  • Change from baseline in sleep efficiency as measured by polysomnography (PSG) and actigraphy [Срок оценки: Baseline, Week 4 and Week 8]

Критерии участия

Критерии включения

Participants will meet the following

  • Outpatients between 8 and 17 years of age at the time of consent
  • Diagnostic and Statistical Manual, 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) or the Childhood Autism Rating Scale, Second Edition (CARS-2).
  • Males and females
  • Availability of polysomnography (PSG) or actigraphy data
  • Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher
  • care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis
  • stable medications for at least 2 weeks, with the exception of Prozac which is required to be stable for at least 4 weeks
  • no planned changes in psychosocial and biomedical interventions during the trial
  • willingness to provide additional saliva samples and participate in key study procedures (i.e., safety measurements every visit, PSG at weeks 4 and 8, and wear the actigraphy watch for 2 weeks before the beginning of trial as well as during the 8 weeks of the trial).

Критерии исключения

Participants will be excluded if one or more of the following is met

  • active suicidal ideation or DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder
  • active medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology)
  • evidence of a metabolic, or infectious etiology for the participant's autism on the basis of medical history, neurologic history, and available tests for inborn errors of metabolism and chromosomal analysis
  • pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)
  • individuals taking benzodiazepines, antiepileptic medications when prescribed for seizure disorder/epilepsy, melatonin and centrally-acting antihistamines
  • history of hypersensitivity to diphenhydramine
  • history of severe side effects from diphenhydramine
  • history of adequate trial of diphenhydramine
  • current use of any medications known to interact with diphenhydramine such as medications inhibiting CYP2D6
  • taking anticholinergic agents (e.g., trihexyphenidyl, thioridazine).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Четверное слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Stanford University — Stanford

Идентификаторы

NCT: NCT05501678 · IRB-66941 · 1P50HD109861

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗