Role of Sleep Apnea in the Neuropsychological Function in Down Syndrome People
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Down Syndrome (DS) is the most common cause of mental retardation with incidence of 1 in 848 (Lin, Hu et al. 1991). Although prenatal Down syndrome and Amniocentesis had been applied for years, in the survey of 2005, current birth incidence of DS is 1.6 in 10,000 live birth, meaning a 30-50 new cases per year (Jou, Kuo et al. 2005). Patients with DS will have multisystemic manifestations including short stature, mental retardation, dysmorphism, congenital heart disease, congenital anomaly of gastrointestinal and genitourinary tract, abnormal endocrine function, leukemia and leukemoid reaction. Beside mental retardation, other anomalies could be treated or controlled by current medical care. The IQ of DS is around 20-80 with significant cognitive, language, and behavior problems (Dierssen, Ortiz-Abalia et al. 2006).
In addition, obstructive sleep apnea syndrome (OSAS) had been observed in DS people with prevalence about 45-79% in the literature (de Miguel-Diez, Villa-Asensi et al. 2003; Dyken, Lin-Dyken et al. 2003; Shott, Amin et al. 2006; Fitzgerald, Paul et al. 2007), which is much higher than the 1-3% prevalence rate in general population (Holmes 1993; Gislason and Benediktsdottir 1995). The reasons of DS people prone to have OSAS are due to the combination of anatomical and physiological factors. In DS people, facial dysmorphism (midfacial hypoplasia, mandibular hypoplasia), macroglossia, small hypopharynx, pharyngeal hypotonia, tonsil and adenoid enlargement, obesity, laryngomalacia, and tracheomalacia contributed to upper airway obstructions in DS people (Trois, Capone et al. 2009; Pandit and Fitzgerald 2012). In addition, DS people has increased incidence of lower respiratory tract diseases including gastroesophageal reflux, immunological dysfunction, tracheal bronchus, airway malacia, congenital heart disease, and pulmonary hypoplasia, which will predispose to OSAS. While growing up, DS people still have generalized hypotonia with increasing risk of developing hypothyroidism and obesity, which are also risk factors for OSAS (Trois, Capone et al. 2009).
It has been noted that sleep disordered breathing is associated with neurocognitive deficit, particularly of memory, learning, attention, hyperactivity, executive functioning, cognitive capacity, and poor school performance (Beebe 2006; Pandit and Fitzgerald 2012). And a number of studies have reported improved attention, executive functioning, analytical thinking, verbal functioning, memory and academic progress at 6-12 months post- adenotonsillectomy (Chervin, Ruzicka et al. 2006). In DS, study demonstrated that a higher number of apneic episodes on polysomnography was correlated to the decreased visuoperceptual skill in DS (Andreou, Galanopoulou et al. 2002). Similarly, presence of snoring in DS was associated with a much higher rate of disruptive school behavior than without snore (Carskadon, Pueschel et al. 1993). Although learning disability and memory defect had been globally known in DS, the behavior, cognitive, and developmental impairment caused by OSAS is especially concerning because it might adversely affect their ability, even the social adaptation (Rihtman, Tekuzener et al. 2010) . Therefore, investigators would like to know the correlation between severity of OSAS and Neurocognitive and behavior in DS people in Taiwan. Also, investigators would like to follow the Neurocognitive and behavior changes in those who had been treated for OSAS, including tonsillectomy or Bilevel Positive Airway Pressure.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Known to have uncontrolled heart, stomach, kidney or neurological / psychiatric disorders.
- Cannot comply with study。
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: Continuous Positive Airway Pressure (CPAP) Therapy
|
If following patients are suffering from sleep apnea and agree to receive treatment,
Investigators will process CPAP treatment for 3 months, and do neuropsychological assessment and sleep examination after treatment for 6 months. |
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessed the sleep apnea level with Apnoea-Hypopnoea Index (AHI) score.
Time Frame: 3 months
|
3 months
|
|
Assessed neuropsychological functions with Wechsler Preschool and Primary Scale of Intelligence (WPPSI-R) vocabulary subdomain score.
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessed the memory domain that subtest of Sentence (WPPSI-R) .
Time Frame: 3 months
|
3 months
|
|
Assessed the memory domain that forward memory (Leiter International Performance Scale-Revised) .
Time Frame: 3 months
|
3 months
|
|
Evaluation of participants's Visuospatial functions with Geometric Design (WPPSI-R).
Time Frame: 3 months
|
3 months
|
|
Evaluation of participants's Visuospatial functions with Block Design (WPPSI-R).
Time Frame: 3 months
|
3 months
|
|
The Executive domain was assessed with TOWER (Developmental NEuroPSYchological Assessment, NEPSY)
Time Frame: 3 months
|
3 months
|
|
Assessed the Language domain with Vocabulary subtest
Time Frame: 3 months
|
3 months
|
|
Assessed the Sensorimotor domain with Visuomotor Precision-train and car
Time Frame: 3 months
|
3 months
|
|
Measurement the effectiveness of therapy before and after treatment with Apnoea-Hypopnoea Index (AHI).
Time Frame: 12 months
|
12 months
|
|
Measurement the effectiveness of therapy before and after treatment with Oxygen Desaturation Index (ODI).
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Ni-Chung Lee, M.D, Ph.D, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 201208075RIC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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