Autism Spectrum DisorderNCT07033078
Sleep, Mood, and Quality of Life Issues in ASD Adolescents and Adults.
An observational study of Autism Spectrum Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 166 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by core symptoms such as social communication difficulties and repetitive behaviors.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Sleep, Mood, and Quality of Life Issues in Adolescents and Adults With Autism and Asperger
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.
Read the detailed description
A.Background Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by core symptoms such as social communication difficulties and repetitive behaviors. Considering the challenges of employment and social environments for adult and adolescents with ASD, sleep problems, quality of life, and functioning may be more severely impacted in adults and adolescents than in children. However, there is few research on sleep problems in adult and adolescents with ASD, as well as a lack of studies on different types of sleep problems in adults and adolescents with ASD. Furthermore, the Social Responsiveness Scale (SRS) is a commonly used assessment tool for ASD, but there are currently lack of validation studies for the adult version of the scale in Taiwan, necessitating further exploration.
B.Purpose This study aims to compare sleep patterns in adults and adolescents with Asperger's syndrome and high-functioning autism using subjective and objective measures such as questionnaires, actigraphy, and PSG. We also explore these factors affecting sleep and related issues including cognitive function, emotional and behavioral problems, autism symptoms, and quality of life. This research will enhance our understanding of sleep problems in Asperger's syndrome and high-functioning autism, tracking the changes in sleep patterns of autism patients at different developmental stages, the relevance to quality of life and prognosis, and also evaluate the reliability and validity of the Chinese Social Responsiveness Scale-Adult Version.
C.Study design This study is a cross-sectional study consisting of two parts. The first part is a retrospective study that includes adolescents and adults with Asperger's syndrome and high-functioning autism who underwent overnight polysomnography in the past. Their sleep studies results and questionnaires were collected. The second part is a prospective study involving outpatient adolescents and adults with Asperger's syndrome and high-functioning autism who have not undergone polysomnography. After enrollment, they undergo sleep studies using subjective and objective measurements including the Pittsburgh Sleep Quality Index (PSQI), actigraphy, and polysomnography. They also complete questionnaires such as the Child Behavior Checklist (CBCL) for assessing emotional and behavioral problems, the Social Responsiveness Scale (SRS), the Aberrant Behavior Checklist (ABC), the Chinese version of the Swanson, Nolan, and Pelham IV Scale (SNAP-IV), and the Adult ADHD Self-Report Scale (ASRS) for assessing autism-related symptoms. Additionally, anxiety and depression symptoms are assessed using the Beck Anxiety Inventory (BAI) and the Beck Depression Inventory (BDI), respectively. The SF-36 Health Survey is used to evaluate quality of life. Correlation analyses are conducted, and comparisons are made with a control group of typically developing adults and adolescents.
D.Predicted results This study aim to predict that sleep patterns in adolescents and adults with autism are associated with depression, anxiety, poorer functioning, lower quality of life, autism symptoms, and poorer prognosis. Considering the increased stress of work and workplace adaptation difficulties in adults and adolescents, they are expected to experience more sleep problems compared to typically developing adults. Additionally, adults and adolescents with Asperger's syndrome and high-functioning autism are likely to exhibit different sleep patterns. Furthermore, additional analysis could be conducted on the reliability and validity of the Chinese version of the Social Responsiveness Scale for adults. The results could then be applied to adults with Autism Spectrum Disorder in Taiwan.
- Conditions
- Autism Spectrum Disorder
- Keywords
- Asperger Disorder, High Functioning Autism, Sleep, Polysomnography, Actigraphy
- Medical subject headings
- Autism Spectrum Disorder, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ASD | Not described | |
| Asperger | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actigraphy
Using actigraphy to assess the differences in sleep patterns between individuals with Autism Spectrum Disorder (ASD) and typically developing controls.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jul 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033078
- Sponsor's protocol ID
- 202400427B0
- Status last verified
- Jul 2024
- First submitted
- 13 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Sleep, Mood, and Quality of Life Issues in Adolescents and Adults With Autism and Asperger
- ClinicalTrials.gov ID
- NCT07033078
- Acronym / sponsor ID
- 202400427B0
- Conditions
- Autism Spectrum Disorder
- Keywords
- Asperger Disorder, High Functioning Autism, Sleep, Polysomnography, Actigraphy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A.Background Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by core symptoms such as social communication difficulties and repetitive behaviors. Considering the challenges of employment and social environments for adult and adolescents with ASD, sleep problems, quality of life, and functioning may be more severely impacted in adults and adolescents than in children. However, there is few research on sleep problems in adult and adolescents with ASD, as well as a lack of studies on different types of sleep problems in adults and adolescents with ASD. Furthermore, the Social Responsiveness Scale (SRS) is a commonly used assessment tool for ASD, but there are currently lack of validation studies for the adult version of the scale in Taiwan, necessitating further exploration.
B.Purpose This study aims to compare sleep patterns in adults and adolescents with Asperger's syndrome and high-functioning autism using subjective and objective measures such as questionnaires, actigraphy, and PSG. We also explore these factors affecting sleep and related issues including cognitive function, emotional and behavioral problems, autism symptoms, and quality of life. This research will enhance our understanding of sleep problems in Asperger's syndrome and high-functioning autism, tracking the changes in sleep patterns of autism patients at different developmental stages, the relevance to quality of life and prognosis, and also evaluate the reliability and validity of the Chinese Social Responsiveness Scale-Adult Version.
C.Study design This study is a cross-sectional study consisting of two parts. The first part is a retrospective study that includes adolescents and adults with Asperger's syndrome and high-functioning autism who underwent overnight polysomnography in the past. Their sleep studies results and questionnaires were collected. The second part is a prospective study involving outpatient adolescents and adults with Asperger's syndrome and high-functioning autism who have not undergone polysomnography. After enrollment, they undergo sleep studies using subjective and objective measurements including the Pittsburgh Sleep Quality Index (PSQI), actigraphy, and polysomnography. They also complete questionnaires such as the Child Behavior Checklist (CBCL) for assessing emotional and behavioral problems, the Social Responsiveness Scale (SRS), the Aberrant Behavior Checklist (ABC), the Chinese version of the Swanson, Nolan, and Pelham IV Scale (SNAP-IV), and the Adult ADHD Self-Report Scale (ASRS) for assessing autism-related symptoms. Additionally, anxiety and depression symptoms are assessed using the Beck Anxiety Inventory (BAI) and the Beck Depression Inventory (BDI), respectively. The SF-36 Health Survey is used to evaluate quality of life. Correlation analyses are conducted, and comparisons are made with a control group of typically developing adults and adolescents.
D.Predicted results This study aim to predict that sleep patterns in adolescents and adults with autism are associated with depression, anxiety, poorer functioning, lower quality of life, autism symptoms, and poorer prognosis. Considering the increased stress of work and workplace adaptation difficulties in adults and adolescents, they are expected to experience more sleep problems compared to typically developing adults. Additionally, adults and adolescents with Asperger's syndrome and high-functioning autism are likely to exhibit different sleep patterns. Furthermore, additional analysis could be conducted on the reliability and validity of the Chinese version of the Social Responsiveness Scale for adults. The results could then be applied to adults with Autism Spectrum Disorder in Taiwan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD | – | – |
| Asperger | – | – |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by core symptoms such as social communication difficulties and repetitive behaviors.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Actigraphy
Time frame: 7 days
Using actigraphy to assess the differences in sleep patterns between individuals with Autism Spectrum Disorder (ASD) and typically developing controls.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actigraphy (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.