NCT07033078

Brief Summary

Autism Spectrum Disorder (ASD) presents unique challenges, particularly in sleep, mood, and quality of life for adolescents and adults. Due to the pressures of life they face, these groups may experience more severe sleep problems and emotional issue and associated issues than children. Current research on these sleep and emotional issues in older ASD individuals is limited, and there is a need for studies on various sleep and emotional problems they encounter. This study aims to compare sleep patterns in adolescents and adults with Asperger's syndrome and high-functioning autism using both subjective and objective measures, such as questionnaires and polysomnography. It also examines the factors influencing sleep, including cognitive function, emotional and behavioral problems, and quality of life. Additionally, the study evaluates the reliability and validity of the Chinese Social Responsiveness Scale-Adult Version in Taiwan. The expected outcome is that sleep and emotional issues in these populations are linked to anxiety, depression, poorer functioning, and lower quality of life.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

June 24, 2025

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

June 13, 2025

Last Update Submit

June 13, 2025

Conditions

Keywords

Asperger DisorderHigh Functioning AutismSleepPolysomnographyActigraphy

Outcome Measures

Primary Outcomes (1)

  • Actigraphy

    Using actigraphy to assess the differences in sleep patterns between individuals with Autism Spectrum Disorder (ASD) and typically developing controls.

    7 days

Study Arms (2)

ASD

Asperger

Eligibility Criteria

Age13 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by core symptoms such as social communication difficulties and repetitive behaviors.

You may qualify if:

  • Subjects diagnosed by a psychiatrist as meeting the DSM-IV-TR diagnosis of Asperger's syndrome or autism.
  • Subjects were aged between 13-45 years old, male or female.
  • The subjects and their families agree to join the trial and sign the subject consent form.

You may not qualify if:

  • Cases where clinical assessment cannot be combined with sleep examination.
  • Cases where the intelligence test result showed that the full scale IQ was \<70.
  • Those with serious physiological diseases, such as congenital heart disease, thyroid dysfunction, immune deficiency diseases, severe autoimmune diseases, brain injuries or severe organic brain diseases, which will affect the evaluation results.
  • Severe mental illness, such as severe schizophrenia, bipolar disorder, etc.
  • Not willing to participate in this study or unwilling to fill out the consent form.
  • Those who are not suitable to enter the trial after being evaluated by the PI and co-PI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan, 333, Taiwan

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAsperger Syndrome

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2025

First Posted

June 24, 2025

Study Start

July 1, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

June 24, 2025

Record last verified: 2024-07

Locations