跳至主要内容
临床试验/NCT06059352
NCT06059352招募中不适用

Contribution of Central Auditory Processing Disorder (CAPD) to Sleep Disturbances in Autism Spectrum Disorder (ASD)

Loma Linda University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Sensory Processing Patterns in Children Ages 14 and Below

研究概览

简要总结

The proposed study aims to understand poor sleep as a possible cause to CAPD in children and adolescents with ASD (ASD+) compared to ASD youth without CAPD (ASD-), using both caregiver-report and objective clinician administered measures. Additionally, the study will aim to understand the complex relationship between CAPD, sleep, and other associated phenotypic features of ASD such as executive and psychiatric functioning.

详细描述

Participation will involve one assessment session approximating 4 hours including administration of neurocognitive and socioemotional measures by trained research staff. The research team then will determine which participants meet CAPD diagnostic criteria for both the SCAN-3 and RGDT tests and assign them to the ASD+ group. Participants not meeting these criteria will be assigned to the ASD- group. Following the assessment visit, all participants will then be asked to wear actigraphy monitors (comparable to overnight polysomnography) regularly for 14 days during nighttime sleep to objectively measure sleep quality.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Have diagnosis of Autism Spectrum Disorder confirmed by the Autism Diagnostic Observation Schedule and the Social Communication Questionnaire, Lifetime Version which will be filled by the parent
  • IQ of 50 or higher on the Abbreviated Battery IQ Score

排除标准

  • No confirmed diagnosis of Autism Spectrum Disorder
  • History of sleep apnea
  • History of restless leg syndrome
  • History of any neurological disorders (e.g., seizures, tumors, etc.)
  • Significant substance use in the past six months
  • Inpatient hospitalization in the past three months-period

研究组 & 干预措施

ASD+ CAPD

This group includes children and adolescence with ASD who also have CAPD. No intervention will be applied to this group.

ASD- CAPD

This group includes children and adolescence with ASD who are not affected by CAPD. No intervention will be applied to this group.

结局指标

主要结局

Sensory Processing Patterns in Children Ages 14 and Below

时间窗: Through study completion, an average of one year

Sensory sensitivity is a composite measurement using the 86 item Sensory Profile 2 (SP-2). SP-2 has 4 quadrants; Seeking (degree child obtains sensory input); Avoiding (degree child is bothered by sensory input); Sensitivity ( degree child detects sensory input); Registration (degree child misses sensory input). SP-2 is completed by parents of subjects using a scale of 5 (almost always = 90% or more), 4 (frequently= 75% of the time), 3 (half of the time = 50%), 2 (occasionally= 25%), 1 (almost never = 10% or less), or does not apply. Seeking quadrant normal limits are 20-47; elevated seeking scores are ≥ 48, reduced seeking behaviors are ≤ 19. Avoiding quadrant normal limits are 21-46; elevated avoiding scores are ≥ 47; reduced avoiding scores are ≤ 20. Sensitivity quadrant normal limits are 18- 42; elevated scores are ≥ 43; reduced scores are ≤ 17 and below. Registration quadrant normal limits are 19-43; elevated scores are ≥ 44; reduced scores are ≤18.

Sensory Processing Patterns in Children Ages 15 and Above

时间窗: Through study completion, an average of one year

Sensory sensitivity is a composite measurement using the 60-item adolescent/ adult sensory profile (AASP). AASP has 4 quadrants: Low Registration, Sensation Seeking, Sensitivity; Avoiding. Subjects will respond using a scale of almost never (5% or less of the time), seldom (25% of the time), occasionally (50% of the time), frequently (75% of the time), and almost always (95% or more of the time). Low Registration normal limits are 27-40; elevated scores are ≥ 41; reduced registration scores are ≤ 26. Sensation seeking normal limits are 42-58; elevated sensation scores are ≥ 59; reduced sensation scores are ≤ 25. Sensitivity normal limits are 26-40; elevated sensitivity scores are ≥ 41; reduced scores are ≤ 25. Avoiding normal limits are 26-40; elevated scores are ≥ 41; reduced scores are ≤ 25.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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