Role of Sleep Apnea in the Neuropsychological Function in Down Syndrome People
1 other identifier
interventional
45
0 countries
N/A
Brief Summary
This is the first study about Neuropsychological function and OSAS in Taiwan. Although the correlation between OSAS and neuropsychological abnormalities had been reported, it is worth to understand more about the detailed domains that involved in our cohort. After this, investigators can dissect the cause of mental retardation in DS and help for further treatment strategies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 17, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedSeptember 5, 2017
August 1, 2017
4 years
August 17, 2017
August 31, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Assessed the sleep apnea level with Apnoea-Hypopnoea Index (AHI) score.
3 months
Assessed neuropsychological functions with Wechsler Preschool and Primary Scale of Intelligence (WPPSI-R) vocabulary subdomain score.
3 months
Secondary Outcomes (9)
Assessed the memory domain that subtest of Sentence (WPPSI-R) .
3 months
Assessed the memory domain that forward memory (Leiter International Performance Scale-Revised) .
3 months
Evaluation of participants's Visuospatial functions with Geometric Design (WPPSI-R).
3 months
Evaluation of participants's Visuospatial functions with Block Design (WPPSI-R).
3 months
The Executive domain was assessed with TOWER (Developmental NEuroPSYchological Assessment, NEPSY)
3 months
- +4 more secondary outcomes
Study Arms (1)
Continuous Positive Airway Pressure (CPAP) Therapy
EXPERIMENTALInterventions
If following patients are suffering from sleep apnea and agree to receive treatment, 1. older than 18 years, AHI\> 15 and present obvious symptoms or 2. less than 18 years, AHI still\> 5 after tonsillectomy and present obvious symptoms. Investigators will process CPAP treatment for 3 months, and do neuropsychological assessment and sleep examination after treatment for 6 months.
Eligibility Criteria
You may qualify if:
- Diagnosed with Down's syndrome by chromosome test, over 6 years old and IQ\> 40.
- Participants and caregiver who are willing and comply with study.
You may not qualify if:
- Known to have uncontrolled heart, stomach, kidney or neurological / psychiatric disorders.
- Cannot comply with study。
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ni-Chung Lee, M.D, Ph.D
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2017
First Posted
August 30, 2017
Study Start
December 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
September 5, 2017
Record last verified: 2017-08